Knee OsteoarthritisNCT02034032
Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA
A study testing Regenexx SD and Exercise Therapy in people with Knee Osteoarthritis, run by Regenexx, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Regenexx SD and Exercise Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2018
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signature of the IRB approved Informed Consent
- Ages 18 to 70
- Diagnosis of Knee osteoarthritis
- Kellgren-Lawrence Grade 2 or 3 on X-Ray
- BMI of <30
- Minimum flexion to 110 degrees
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- Varus under 12 degrees/Valgus under 15 degrees
- Instability in any plane less than 2 mm translation
- ACL intact and no history of ACL reconstruction
- Knee Society 100 point score > 65
- If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
- Candidate is able to follow Regenexx medication guidelines
- Patient agrees to return for periodic assessment protocol
- Patient must execute all required documents
- Patient must be appraised of Clinical Trial
Who cannot join
- History of infection of the joint in the last five years
- Intra-articular PRP, steroid or viscosupplementation in the last three months
- Previous knee surgery within the last 6 months
- Flexion contracture over 15 degrees
- Low back pain with radiculopathy or with "significant" radiographic changes
- History of immunosuppressive or chemotherapy in the last five years
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- Systemic neurological disease
- HIV positive or chronic hepatitis
- Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute
Des Plaines, Illinois, 60016
About this study
Official title: A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to Total Knee Arthroplasty
The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.
Read the detailed description
The study is single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with Regenexx SD and 25 treated with Exercise Therapy for treatment of knee osteoarthritis. Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of Exercise Therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.
Subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit and then continue to be followed through 24 months.
Subjects will complete the study following the 2 year follow-up visit. They will be withdrawn from the study prematurely if a revision occurs.
The study subjects will be compared to a historical total knee arthroplasty group. Data of the TKA group subjects will be reviewed retrospectively after it is retrieved from the clinical database. The TKA group will consist of patients who underwent TKA for knee osteoarthritis. The inclusion criteria of age and BMI will be applied to these subjects.
- Conditions
- Knee Osteoarthritis
- Being tested
- Regenexx SD, Exercise Therapy
- Keywords
- Osteoarthritis, Knee, Arthritis, TKA, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenexx SDProcedure or surgery
stem cell treatment
Exercise TherapyBehavioural
exercise therapy control
| Study group | Role | What they receive |
|---|---|---|
| Regenexx SD | Active comparator | Regenexx-SD (Same Day) is a bone marrow based injection procedure. Receives: Procedure: Regenexx SD |
| Exercise Therapy | Active comparator | Subjects in the Exercise Therapy group will attend an initial session with a trained Physical Therapist. During that session the physical therapist will instruct the subject in a home exercise program and instructions about activity limitations. The subject's progress will also be followed by the Physical Therapist during the 6 week follow-up visit with further instructions provided. Receives: Behavioral: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Scores
Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months
Measured: 3 months
Secondary outcomes (2)
KSS means difference between Regenexx SD and historical TKA data
The KSS means difference between Regenexx SD and historical TKA data measured at 1 year
Measured: 1 year
KSS means difference between Regenexx SD and historical TKA data
The KSS means difference between Regenexx SD and historical TKA data measured at 2 years
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Sheinkop, M.D., Principal investigator, Regenerative Pain Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034032
- Sponsor's protocol ID
- MM-03-K
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2014
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8.
PubMed 30545387
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02034032
- Acronym / sponsor ID
- MM-03-K
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Arthritis, TKA, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Jan 2014 (estimated)
- 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.
The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.
Detailed description
The study is single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with Regenexx SD and 25 treated with Exercise Therapy for treatment of knee osteoarthritis. Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of Exercise Therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.
Subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit and then continue to be followed through 24 months.
Subjects will complete the study following the 2 year follow-up visit. They will be withdrawn from the study prematurely if a revision occurs.
The study subjects will be compared to a historical total knee arthroplasty group. Data of the TKA group subjects will be reviewed retrospectively after it is retrieved from the clinical database. The TKA group will consist of patients who underwent TKA for knee osteoarthritis. The inclusion criteria of age and BMI will be applied to these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenexx SD | Active comparator | Procedure: Regenexx SDRegenexx-SD (Same Day) is a bone marrow based injection procedure. |
| Exercise Therapy | Active comparator | Behavioral: Exercise TherapySubjects in the Exercise Therapy group will attend an initial session with a trained Physical Therapist. During that session the physical therapist will instruct the subject in a home exercise program and instructions about activity limitations. The subject's progress will also be followed by the Physical Therapist during the 6 week follow-up visit with further instructions provided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntary signature of the IRB approved Informed Consent
- Ages 18 to 70
- Diagnosis of Knee osteoarthritis
- Kellgren-Lawrence Grade 2 or 3 on X-Ray
- BMI of <30
Key exclusion criteria (9 listed)
- History of infection of the joint in the last five years
- Intra-articular PRP, steroid or viscosupplementation in the last three months
- Previous knee surgery within the last 6 months
- Flexion contracture over 15 degrees
- Low back pain with radiculopathy or with "significant" radiographic changes
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 |
|---|---|---|
| Regenexx SDstem cell treatment | Procedure or surgery | Regenexx SD |
| Exercise Therapyexercise therapy control | Behavioural | Exercise Therapy |
Primary outcome
Knee Society Scores
Time frame: 3 months
Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months
2 secondary outcomes
KSS means difference between Regenexx SD and historical TKA data
Time frame: 1 year
KSS means difference between Regenexx SD and historical TKA data
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 30545387Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8.
- 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.
Mitchell Sheinkop, M.D. principal investigator
Regenerative Pain Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenexx SD and Exercise Therapy in people with Knee Osteoarthritis, run by Regenexx, LLC 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 15 inclusion and 9 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: finished, as of the sponsor's last update on 4 Jan 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee Society Scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034032, which also lists 1 linked publication.
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 4 Jan 2019.