Knee OsteoarthritisNCT04405297
A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by Sanford Health at 1 site in United States.
Trial summary
This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis, Ankle Osteoarthritis
- What is being tested?
- Adipose-derived regenerative cells
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 23 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The focus of this study is to investigate the therapeutic benefit of autologous ADRCs in patients with OA in various joints. The ENDURE study allows subjects at Sanford Health and in the United States access to adipose-derived regenerative cells while reviewing safety for subjects with knee, shoulder, hip, ankle and wrist OA, using a more pragmatic and standard clinical approach.
Who may be able to join
- Men and women age 18 or older
- Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip, Knee, Shoulder, or Wrist
- Continued OA pain in the targeted joint despite conservative measures (per treating provider's discretion)
- Average daily VAS Pain Score ≥3
- Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
- On physical exam. subject appears to have adequate adipose tissue for liposuction
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- Subject must also meet additional inclusion criteria specific to the targeted joint cohort
- Ankle Cohort:
- Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray (weight-bearing mortise views with 20⁰ internal rotation)
- Ankle pain for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
- Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
- Hip Cohort:
- 1. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or 3)
- Knee Cohort:
- Kellgren-Lawrence system of Grade II, III, or IV
- Subject may have concomitant patellofemoral but they must have stage II or higher generalized knee OA
- Shoulder Cohort:
- Grades 1, 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view)
- Subjects who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
- The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- Activity modification
- Wrist Cohort:
- 1. Clinical symptoms consistent with wrist OA
Who cannot join
- Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort
- Viscosupplementation within 6 months of screening in the targeted joint
- Other Biologic Injection (Platelet Rich Plasma (PRP) or stem cell) within 6 months in the targeted joint
- Surgery in the targeted joint within the past 6 months (either open or scope)
- Planned/anticipated surgery of the targeted joint during study participation
- Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening (re-screening allowed once this criteria is met)
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- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry.
- Part of a vulnerable population per Office for Human Research Protections (OHRP) definition (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc.)
- Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7 calendar days prior to the procedure
- Unwilling to discontinue NSAIDS for 5 calendar days after procedure
- Insufficient amount of subcutaneous tissue to allow recovery of at least 100mL of lipoaspirate
- Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
- Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to an injection procedure.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. (Nonintervention observational studies are not exclusionary.)
- History of, or ongoing, autoimmune disorder that requires treatment with an immunosuppressive medication
- Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, and sepsis in the treatment site
- History of bleeding disorders or inflammatory joint disease
- Inability to hold anti-platelet therapy according to treating provider prior to procedure
- Any medical condition that could preclude participation in the study in the opinion of the investigator
- Active workers' compensation case in progress with the targeted joint
- Daily opioid use for the 3 months prior to screening or anticipated daily use while participating on study
- Psychiatric disorder that may prevent participation in the study in the opinion of the investigators
- A positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid test
- Has a known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected)
- Allergy to sodium citrate of any "caine" type of local anesthetic
- Hemoglobin less than 10g/dL at the time of screening
- Leukocytes <3,000/µL; neutrophils <1,500/µL; lymphocytes <800/µL; platelets <100,000/µL at the time of screening
- Subjects with a known diagnosis of osteoporosis
- Diagnosis of liver disease as defined by alanine aminotransferase (ALT) >2x the upper limit of age-determined normal (ULN) or total bilirubin > 1.5x ULN
- Ankle Cohort:
- Lower leg trauma in a location other than within the ankle
- Arthroscopy or open surgery of the ankle joint within 6 months of screening.
- Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40)
- Any condition other than OA of the ankle joint which, in the opinion of the investigator, affects their ability to ambulate to a sufficient degree to interfere with the assessment of the safety and treatment effects of the study injection.
- Hip Cohort:
- Evidence of hip dysplasia (centre edge angle less than 20⁰)
- Previous fracture trauma to the affected hip requiring medical or surgical treatment
- Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
- Infections or skin diseases at target hip joint
- Significant medical co-morbidities (requiring daily assistance for activities of daily living)
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
- Femoral head deformity (perthes or AVN)
- Knee Cohort:
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
- Clinically apparent tense effusion of the targeted knee
- Significant valgus/varus deformities (+/- 10⁰)
- Shoulder Cohort:
- Walch B2 glenoid with greater than 10⁰ of retroversion
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Wrist Cohort:
- 1. Subjects who have a documented diagnosis of active carpal tunnel syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanford Orthopedics and Sports Medicine
Sioux Falls, South Dakota, 57104
About this study
This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.
Read the detailed description
Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment.
The subject will have an injection procedure (ADRC treatment) For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a non-Investigator physician (e.g., a plastic surgeon) who is trained on the study protocol.
All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose® RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRCs.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis, Ankle Osteoarthritis, Shoulder Osteoarthritis, Wrist Osteoarthritis
- Being tested
- Adipose-derived regenerative cells
- Keywords
- Stem Cells, Adipose-derived regenerative cells, Osteoarthritis, Adipose-derived stem cells, Arthritis, Joint Diseases
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived regenerative cellsDevice
Adipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint.
| Study group | Role | What they receive |
|---|---|---|
| Hip Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected hip joint. Receives: Device: Adipose-derived regenerative cells | |
| Knee Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected knee joint. Receives: Device: Adipose-derived regenerative cells | |
| Ankle Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected ankle joint. Receives: Device: Adipose-derived regenerative cells | |
| Shoulder Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected shoulder joint. Receives: Device: Adipose-derived regenerative cells | |
| Wrist Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected wrist joint. Receives: Device: Adipose-derived regenerative cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as indicated by incidence (%) of unanticipated AEs. All AEs and SAEs will be graded on severity by the Investigator using the National Institutes of Health Common Terminology Criteria for Adverse Events (NIH CTCAE).
A one-sided binomial test will be used with a significance level of 0.05 to test whether safety was significantly lower than 20%. Each cohort will be analyzed independently.
Measured: Up to 2 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using PROMIS 10 Global health
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using SF-12v2
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients.Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Visual Analog Pain Scale (VAS-Pain)
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Knee Osteoarthritis Outcome Score (KOOS)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a valid, reliable, and responsive outcome measure in total joint replacement (E. T.-L. Roos 2003). KOOS is a self-administered questionnaire that assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The KOOS's patient-reported questionnaire utilizes 5-point Likert scale, options scored from 0 (No problems) to 4 (Extreme problems).
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the knee
Ranges include:
0-140 degrees flexion 0 degrees extension
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using PROMIS 10 Global health
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using SF-12v2
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Visual Analog Pain Scale (VAS-Pain)
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using American Surgeon and Elbow Surgeon (ASES) measure
The ASES is a 100-point scale that consists of questions related to pain and activities of daily living. It is comprised of patient self-evaluation section and a physician assessment section.The activities of daily living questionnaire are marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. The physician assessment section includes demographic information and assess range of motion, specific physical signs, strength and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). The ASES is a 17-item patient-reported questionnaire utilizing a 10-point pain scale ranging from 0="No pain at all" to 10="Pain as bad as it can be" and a 4-point activities of daily living scale ranging from 0="Unable to do" to 3="Normal"
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Oxford Shoulder Score
The Oxford Shoulder Score (OSS) is validated patient-reported outcome providing researchers and clinicians with a quantitative measure of a patient's response after a surgical and non-surgical shoulder intervention. Developed by the Department of Public Heath in the United Kingdom, the OSS is a 12-item tool used to review patient's pain and function, and is widely utilized in clinical trials. The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from "None"/No trouble at all" to "Unbearable"/"Impossible to do".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in the range of motion of the shoulder (ROM)
Ranges include:
0-180 degrees forward flexion 0-150 degrees abduction 30 degrees adduction 70-90 degrees internal rotation 0-90 degrees external rotation
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS 10 Global health
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using SF-12v2
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Pain Score Analog Scale (VAS-Pain)
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Quick-Dash
The subject will complete the QuickDASH by scoring each item of the questionnaire with scores between 1 (no difficulty at all) and 5 (unable to do), with higher scores indicating greater disability (Hudak 1996, Kennedy 2011). The QuickDASH questionnaire is considered complete when 10 of the total 11 items are answered. The QuickDASH is an 11 item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from 1="No difficulty"/"None" to 5="Unable to perform"/"Extreme".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS-Upper Extremity
The subject will complete the PROMIS self-report without help from anyone else. The respondents will be given the optimal time needed to capture the most relevant perspective and complete data (e.g., before/after clinician visit or in between visits). All results will be recorded and analyzed in accordance with standard practice. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.PROMIS- Upper Extremity is a 7-item patient-reported questionnaire utilizing as 5-point scale ranging from 5="Without any difficulty" to 1="Unable to do".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in the range of motion of the wrist (ROM)
Ranges include:
0-75 degrees flexion 0-70 degrees extension 50 degrees radioulnar deviation arc
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using PROMIS 10 Global health
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using SF-12v2
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Pain Score on Visual Analog (VAS-Pain)
VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is Sanford Health Confidential commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Foot and Ankle Disability Index (FADI)
The Foot and Ankle Disability Index (FADI) is a 34-item questionnaire divided into two sub-scales: the Foot and Ankle Disability Index and the Foot and Ankle Sports Disability index (Hale 2005). Although not one foot and ankle self-reported measure has been determined as the most reliable, FADI is designed to detect deficits in higher functioning subjects and is more sensitive to responses after deliberate intervention. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The FADI is a 34-item patient-reported questionnaire utilizing a 5-point scale ranging from 0% (most disability) to 100% (least disability), e.g. 0="Unable to do"/"Unbearable" to 4="No difficulty"/"No Pain".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in the range of motion of the ankle (ROM)
Ranges include:
0-40 degrees plantar flexion 0-20 degrees dorsiflexion 0-30 degrees inversion 0-20 degrees eversion
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using PROMIS 10 Global health
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using SF-12v2
The SF-12v2 is a generic health outcome measurement widely used. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using Pain Score on Visual Analog Scale (VAS-Pain)
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using the Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS is a patient-administered questionnaire consisting of 40 items across five subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items) and Hip Related Quality of Life (4 items). The HOOS is scored on a Likert scale of 0 to 4 (no, mild, moderate, severe and extreme) with a total score is calculated by using a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms, with higher scores representing better function.
Measured: Through study completion, up to 3 years
Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the hip
Ranges include:
0-125 degrees flexion 115-0 degrees extension 0-15 degrees hyperextension 0-45 degrees abduction 0-20 degrees adduction
Measured: Through study completion, up to 3 years
Secondary outcomes (1)
The secondary objective is to create a data registry for future research on ADRC use for OA
The registry will only contain treated individuals. Future analyses will analyze all subjects, subsets of subjects based on area of treatment, or potentially match treated subjects to similar control subjects for comparison of outcomes.
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start24 May 2021
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Why it stopped: The sponsor decided to close the study early due to low patient enrollment and the sponsor no longer pursuing stem cell therapy treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A. Pearce, PhD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405297
- Sponsor's protocol ID
- ENDURE
- Status last verified
- Oct 2025
- First submitted
- 8 May 2020
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells
- ClinicalTrials.gov ID
- NCT04405297
- Acronym / sponsor ID
- ENDURE
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis, Ankle Osteoarthritis, Shoulder Osteoarthritis, Wrist Osteoarthritis
- Keywords
- Stem Cells, Adipose-derived regenerative cells, Osteoarthritis, Adipose-derived stem cells, Arthritis, Joint Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor decided to close the study early due to low patient enrollment and the sponsor no longer pursuing stem cell therapy treatment.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.
Detailed description
Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment.
The subject will have an injection procedure (ADRC treatment) For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a non-Investigator physician (e.g., a plastic surgeon) who is trained on the study protocol.
All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose® RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hip Osteoarthritis | – | Device: Adipose-derived regenerative cellsSubjects will receive autologous adipose-derived regenerative stem cells into their affected hip joint. |
| Knee Osteoarthritis | – | Device: Adipose-derived regenerative cellsSubjects will receive autologous adipose-derived regenerative stem cells into their affected knee joint. |
| Ankle Osteoarthritis | – | Device: Adipose-derived regenerative cellsSubjects will receive autologous adipose-derived regenerative stem cells into their affected ankle joint. |
| Shoulder Osteoarthritis | – | Device: Adipose-derived regenerative cellsSubjects will receive autologous adipose-derived regenerative stem cells into their affected shoulder joint. |
| Wrist Osteoarthritis | – | Device: Adipose-derived regenerative cellsSubjects will receive autologous adipose-derived regenerative stem cells into their affected wrist joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The focus of this study is to investigate the therapeutic benefit of autologous ADRCs in patients with OA in various joints. The ENDURE study allows subjects at Sanford Health and in the United States access to adipose-derived regenerative cells while reviewing safety for subjects with knee, shoulder, hip, ankle and wrist OA, using a more pragmatic and standard clinical approach.
Key inclusion criteria (23 listed)
- Men and women age 18 or older
- Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip, Knee, Shoulder, or Wrist
- Continued OA pain in the targeted joint despite conservative measures (per treating provider's discretion)
- Average daily VAS Pain Score ≥3
- Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
Key exclusion criteria (55 listed)
- Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort
- Viscosupplementation within 6 months of screening in the targeted joint
- Other Biologic Injection (Platelet Rich Plasma (PRP) or stem cell) within 6 months in the targeted joint
- Surgery in the targeted joint within the past 6 months (either open or scope)
- Planned/anticipated surgery of the targeted joint during study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose-derived regenerative cellsAdipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint. | Device | Ankle Osteoarthritis, Hip Osteoarthritis, Knee Osteoarthritis, Shoulder Osteoarthritis, Wrist Osteoarthritis |
Primary outcome
Safety as indicated by incidence (%) of unanticipated AEs. All AEs and SAEs will be graded on severity by the Investigator using the National Institutes of Health Common Terminology Criteria for Adverse Events (NIH CTCAE).
Time frame: Up to 2 years
A one-sided binomial test will be used with a significance level of 0.05 to test whether safety was significantly lower than 20%. Each cohort will be analyzed independently.
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using PROMIS 10 Global health
Time frame: Through study completion, up to 3 years
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using SF-12v2
Time frame: Through study completion, up to 3 years
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients.Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Visual Analog Pain Scale (VAS-Pain)
Time frame: Through study completion, up to 3 years
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Knee Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, up to 3 years
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a valid, reliable, and responsive outcome measure in total joint replacement (E. T.-L. Roos 2003). KOOS is a self-administered questionnaire that assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The KOOS's patient-reported questionnaire utilizes 5-point Likert scale, options scored from 0 (No problems) to 4 (Extreme problems).
Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the knee
Time frame: Through study completion, up to 3 years
Ranges include: 0-140 degrees flexion 0 degrees extension
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using PROMIS 10 Global health
Time frame: Through study completion, up to 3 years
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using SF-12v2
Time frame: Through study completion, up to 3 years
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Visual Analog Pain Scale (VAS-Pain)
Time frame: Through study completion, up to 3 years
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using American Surgeon and Elbow Surgeon (ASES) measure
Time frame: Through study completion, up to 3 years
The ASES is a 100-point scale that consists of questions related to pain and activities of daily living. It is comprised of patient self-evaluation section and a physician assessment section.The activities of daily living questionnaire are marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. The physician assessment section includes demographic information and assess range of motion, specific physical signs, strength and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). The ASES is a 17-item patient-reported questionnaire utilizing a 10-point pain scale ranging from 0="No pain at all" to 10="Pain as bad as it can be" and a 4-point activities of daily living scale ranging from 0="Unable to do" to 3="Normal"
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Oxford Shoulder Score
Time frame: Through study completion, up to 3 years
The Oxford Shoulder Score (OSS) is validated patient-reported outcome providing researchers and clinicians with a quantitative measure of a patient's response after a surgical and non-surgical shoulder intervention. Developed by the Department of Public Heath in the United Kingdom, the OSS is a 12-item tool used to review patient's pain and function, and is widely utilized in clinical trials. The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from "None"/No trouble at all" to "Unbearable"/"Impossible to do".
Efficacy outcomes include changes in the range of motion of the shoulder (ROM)
Time frame: Through study completion, up to 3 years
Ranges include: 0-180 degrees forward flexion 0-150 degrees abduction 30 degrees adduction 70-90 degrees internal rotation 0-90 degrees external rotation
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS 10 Global health
Time frame: Through study completion, up to 3 years
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using SF-12v2
Time frame: Through study completion, up to 3 years
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Pain Score Analog Scale (VAS-Pain)
Time frame: Through study completion, up to 3 years
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Quick-Dash
Time frame: Through study completion, up to 3 years
The subject will complete the QuickDASH by scoring each item of the questionnaire with scores between 1 (no difficulty at all) and 5 (unable to do), with higher scores indicating greater disability (Hudak 1996, Kennedy 2011). The QuickDASH questionnaire is considered complete when 10 of the total 11 items are answered. The QuickDASH is an 11 item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from 1="No difficulty"/"None" to 5="Unable to perform"/"Extreme".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS-Upper Extremity
Time frame: Through study completion, up to 3 years
The subject will complete the PROMIS self-report without help from anyone else. The respondents will be given the optimal time needed to capture the most relevant perspective and complete data (e.g., before/after clinician visit or in between visits). All results will be recorded and analyzed in accordance with standard practice. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.PROMIS- Upper Extremity is a 7-item patient-reported questionnaire utilizing as 5-point scale ranging from 5="Without any difficulty" to 1="Unable to do".
Efficacy outcomes include changes in the range of motion of the wrist (ROM)
Time frame: Through study completion, up to 3 years
Ranges include: 0-75 degrees flexion 0-70 degrees extension 50 degrees radioulnar deviation arc
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using PROMIS 10 Global health
Time frame: Through study completion, up to 3 years
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using SF-12v2
Time frame: Through study completion, up to 3 years
The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Pain Score on Visual Analog (VAS-Pain)
Time frame: Through study completion, up to 3 years
VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is Sanford Health Confidential commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Foot and Ankle Disability Index (FADI)
Time frame: Through study completion, up to 3 years
The Foot and Ankle Disability Index (FADI) is a 34-item questionnaire divided into two sub-scales: the Foot and Ankle Disability Index and the Foot and Ankle Sports Disability index (Hale 2005). Although not one foot and ankle self-reported measure has been determined as the most reliable, FADI is designed to detect deficits in higher functioning subjects and is more sensitive to responses after deliberate intervention. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The FADI is a 34-item patient-reported questionnaire utilizing a 5-point scale ranging from 0% (most disability) to 100% (least disability), e.g. 0="Unable to do"/"Unbearable" to 4="No difficulty"/"No Pain".
Efficacy outcomes include changes in the range of motion of the ankle (ROM)
Time frame: Through study completion, up to 3 years
Ranges include: 0-40 degrees plantar flexion 0-20 degrees dorsiflexion 0-30 degrees inversion 0-20 degrees eversion
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using PROMIS 10 Global health
Time frame: Through study completion, up to 3 years
The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using SF-12v2
Time frame: Through study completion, up to 3 years
The SF-12v2 is a generic health outcome measurement widely used. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using Pain Score on Visual Analog Scale (VAS-Pain)
Time frame: Through study completion, up to 3 years
A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using the Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: Through study completion, up to 3 years
The HOOS is a patient-administered questionnaire consisting of 40 items across five subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items) and Hip Related Quality of Life (4 items). The HOOS is scored on a Likert scale of 0 to 4 (no, mild, moderate, severe and extreme) with a total score is calculated by using a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms, with higher scores representing better function.
Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the hip
Time frame: Through study completion, up to 3 years
Ranges include: 0-125 degrees flexion 115-0 degrees extension 0-15 degrees hyperextension 0-45 degrees abduction 0-20 degrees adduction
1 secondary outcome
The secondary objective is to create a data registry for future research on ADRC use for OA
Time frame: Through study completion, up to 3 years
Results and safety
The study was stopped early (reason given: The sponsor decided to close the study early due to low patient enrollment and the sponsor no longer pursuing stem cell therapy treatment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Pearce, PhD principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by Sanford Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The sponsor decided to close the study early due to low patient enrollment and the sponsor no longer pursuing stem cell therapy treatment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as indicated by incidence (%) of unanticipated AEs. All AEs and SAEs will be graded on severity by the Investigator using the National Institutes of Health Common Terminology Criteria for Adverse Events (NIH CTCAE). (time frame: Up to 2 years). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.