OsteoarthritisPhase 1/2NCT03866330
Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
A Phase 1/2 study testing Intraarticular injection of WJMSC in people with Osteoarthritis and Hip Osteoarthritis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Intraarticular injection of WJMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2019to 1 Mar 2022
- Phase
- Phase 1/2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of osteoarthritis of the knee, hip or glenohumeral joint,
- confirmation cartilage injury, articular cartilage part or full-thickness injury by MR (Magnetic Resonance),
- joint pain of VAS (visual analog scale score) is 1 or higher while resting, 2 and higher during any physical activity,
- loss of joint function based on scale specific for certain joints; for hip: HHS scale (Harris Hip Score), HOOS scale (Hip disability and Osteoarthritis Outcome Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC); for knee: modified HHS score (Harris Hip Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC), The International Knee Documentation Committee (IKDC Questionnaire) and KOOS scale (Osteoarthritis Outcome Score); glenohumeral joint: Disability of Arm, Shoulder and Hand [DASH], CONSTANT score,
- clinical indication for surgical intervention,
- no effect of pharmacotherapy according to The World Health Organization (WHO) analgesic ladder lasting at least 6 months,
- no effect of physical rehabilitation lasting at least 6 months,
- willing to participate understand and sign the consent form of this study.
Who cannot join
- active inflammatory disease or infection,
- skin disease/infection around joint,
- severe heart failure,
- anemia,
- active/history of human immunodeficiency viruses (HIV), the hepatitis B virus (HBV) or the hepatitis C virus (HCV) infection,
- pregnant or breast-feeding women,
Show all 9Show fewer
- mental disease, addiction to drugs or alcohol,
- participate other clinical experiments in 6 months,
- refuse to sign the consent form, or cannot keep follow-up visit.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Life Clinic
Warsaw, Mazovian, 00-132
Robert Śmigielski, MD, +48609455055
Robert Śmigielski
About this study
Official title: Effectiveness of Wharton's Jelly-derived Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features
This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive every three months a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) form the Polish Stem Cell Bank for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection.
Read the detailed description
This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. All patients are selected and sign consent forms, then divided into 3 groups based on clinical presentation. Subjects will receive a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) prepared by the Polish Stem Cell Bank every three months for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection. During the study period and 24 months after last injection they will be followed by clinical assessment, laboratory investigations including inflammatory markers and microRNA, as well as magnetic resonance imaging (MRI) of the injected joint. The investigators will also determine the local and systemic safety of the procedure and therapy with WJMSC.
- Being tested
- Intraarticular injection of WJMSC
- Keywords
- Osteoarthritis, Wharton Jelly derived Mesenchymal Stem Cells
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarticular injection of WJMSCBiological
ultrasound guided intra-articular injection of at least 10 million of Wharton's jelly-derived mesenchymal stem cells per procedure
| Study group | Role | What they receive |
|---|---|---|
| osteoarthritis of the knee | Active comparator | Intraarticular injection of WJMSC Receives: Biological: Intraarticular injection of WJMSC |
| osteoarthritis of the hip | Active comparator | Intraarticular injection of WJMSC Receives: Biological: Intraarticular injection of WJMSC |
| osteoarthritis of the glenohumeral joint | Active comparator | Intraarticular injection of WJMSC Receives: Biological: Intraarticular injection of WJMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS)
Change in HOOS score. HOOS consists of 5 subscales: pain, other symptoms, function in activities of daily living (ADL), and function in sport and recreation (Sport/Rec), and hip-related quality of life (QOL). In total, 40 items: 10 items for pain, 5 items for other symptoms (3 for symptoms and 2 for stiff- ness), 17 items for function in ADL, 4 items for function in Sport/Rec, and 4 items for hip-related QOL. Standardized answer options are given (5 Likert boxes) and each question is scored from 0 to 4. Scores are summarized for each subscale and trans- formed to a 0-100 scale (0 indicating extreme problems and 100 indicating no problems).
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Harris Hip Score
Change in Harris Hip Score (HHS) The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS score
It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
modified Harris Hip Score for knee
Change in modified Harris Hip Score (HHS) The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
The International Knee Documentation Committee (IKDC Questionnaire)
Change in IKDC Questionnaire score
The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee.
Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function
The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
WOMAC (for hip and knee)
Change in WOMAC score. WOMAC score is used to assess patients with osteoarthritis of the hip or knee using 24 parameters in 5 categories.
1 Pain 2.Stiffness 3.Physical function 4.Social function 5. Emotional function
Scoring and Interpretation
Response : points none - 0 slight 1 moderate 2 severe 3 extreme 4
score = = summary (points for relevant items) average score = = (total score) / (number of items) Interpretation: minimum total score: 0 maximum total score: 96 minimum pain subscore: 0 maximum pain subscore: 20 minimum stiffness subscore: 0 maximum stiffness subscore: 8 minimum physical function subscore: 0 maximum physical function subscore: 6
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Disability of Arm, Shoulder and Hand [DASH]
Change in DASH score
The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items).
The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability
A minimum score is 30; a maximum is 150. The range of the scores, therefore-from 30 to 150-equals 120. The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
The Constant-Murley score (CMS)
Change in CMS. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Visual Analog Scale (VAS)
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control The VAS is a commonly used tool in health outcome studies, when using it to assess importance of certain action or intervention, how we can interpret the results, on 1 to 10 line (where 1; the least and the 10; the highest),
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Secondary outcomes (7)
1. Nature, incidence and severity of adverse events (AEs)
Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.
Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups. Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.
Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups
Measured: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
2. Change in radiographic/magnetic resonance joint morphology
Change in radiographic/magnetic resonance joint morphology
Measured: Baseline, and 12 months post-treatment cycle
3. Change in cartilage thickness
Cartilage thickness on MRI
Measured: Baseline, and 12 months post-treatment cycle
4. Change in cartilage volume
Cartilage volume on MRI
Measured: Baseline, and 12 months post-treatment cycle
5. Change in cartilage morphology
Cartilage morphology on MRI
Measured: Baseline, and 12 months post-treatment cycle
6. Change in subchondral bone morphology
Subchondral bone morphology (i.e. edema) on MRI
Measured: Baseline, and 12 months post-treatment cycle
8. Inflammation monitoring
Baseline, and 12 months post-treatment cycle based on changes of concentrations of interleukin (IL)-1β (pg/ml), IL-6 (pg/ml), IL-8 (pg/ml), IL-11 (pg/ml), CD40L (ng/ml), tumor necrosis factor (TNF)-alpha (pg/ml), high-sensivity C-reactive protein (hsCRP) (mg/dl) and miRNA expression (ug/dl) defined on microarray profilling.
Measured: Baseline, and 12 months post-treatment cycle]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Mar 2019
- Primary completionDec 2019 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Postula, Medical University of Warsaw
- Investigators
- Marek Postula, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866330
- Sponsor's protocol ID
- 001/LIFE/2019
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Wharton's Jelly-derived Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features
- ClinicalTrials.gov ID
- NCT03866330
- Acronym / sponsor ID
- 001/LIFE/2019
- Keywords
- Osteoarthritis, Wharton Jelly derived Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 7 Mar 2019 (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 phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive every three months a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) form the Polish Stem Cell Bank for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection.
Detailed description
This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. All patients are selected and sign consent forms, then divided into 3 groups based on clinical presentation. Subjects will receive a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) prepared by the Polish Stem Cell Bank every three months for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection. During the study period and 24 months after last injection they will be followed by clinical assessment, laboratory investigations including inflammatory markers and microRNA, as well as magnetic resonance imaging (MRI) of the injected joint. The investigators will also determine the local and systemic safety of the procedure and therapy with WJMSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| osteoarthritis of the knee | Active comparator | Biological: Intraarticular injection of WJMSCIntraarticular injection of WJMSC |
| osteoarthritis of the hip | Active comparator | Biological: Intraarticular injection of WJMSCIntraarticular injection of WJMSC |
| osteoarthritis of the glenohumeral joint | Active comparator | Biological: Intraarticular injection of WJMSCIntraarticular injection of WJMSC |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- presence of osteoarthritis of the knee, hip or glenohumeral joint,
- confirmation cartilage injury, articular cartilage part or full-thickness injury by MR (Magnetic Resonance),
- joint pain of VAS (visual analog scale score) is 1 or higher while resting, 2 and higher during any physical activity,
- loss of joint function based on scale specific for certain joints; for hip: HHS scale (Harris Hip Score), HOOS scale (Hip disability and Osteoarthritis Outcome Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC); for knee: modified HHS score (Harris Hip Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC), The International Knee Documentation Committee (IKDC Questionnaire) and KOOS scale (Osteoarthritis Outcome Score); glenohumeral joint: Disability of Arm, Shoulder and Hand [DASH], CONSTANT score,
- clinical indication for surgical intervention,
Key exclusion criteria (9 listed)
- active inflammatory disease or infection,
- skin disease/infection around joint,
- severe heart failure,
- anemia,
- active/history of human immunodeficiency viruses (HIV), the hepatitis B virus (HBV) or the hepatitis C virus (HCV) infection,
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 |
|---|---|---|
| Intraarticular injection of WJMSCultrasound guided intra-articular injection of at least 10 million of Wharton's jelly-derived mesenchymal stem cells per procedure | Biological | osteoarthritis of the glenohumeral joint, osteoarthritis of the hip, osteoarthritis of the knee |
Primary outcome
HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Change in HOOS score. HOOS consists of 5 subscales: pain, other symptoms, function in activities of daily living (ADL), and function in sport and recreation (Sport/Rec), and hip-related quality of life (QOL). In total, 40 items: 10 items for pain, 5 items for other symptoms (3 for symptoms and 2 for stiff- ness), 17 items for function in ADL, 4 items for function in Sport/Rec, and 4 items for hip-related QOL. Standardized answer options are given (5 Likert boxes) and each question is scored from 0 to 4. Scores are summarized for each subscale and trans- formed to a 0-100 scale (0 indicating extreme problems and 100 indicating no problems).
Harris Hip Score
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Change in Harris Hip Score (HHS) The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Change in KOOS score It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL) The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.
modified Harris Hip Score for knee
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Change in modified Harris Hip Score (HHS) The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
The International Knee Documentation Committee (IKDC Questionnaire)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
Change in IKDC Questionnaire score The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
WOMAC (for hip and knee)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Change in WOMAC score. WOMAC score is used to assess patients with osteoarthritis of the hip or knee using 24 parameters in 5 categories. 1 Pain 2.Stiffness 3.Physical function 4.Social function 5. Emotional function Scoring and Interpretation Response : points none - 0 slight 1 moderate 2 severe 3 extreme 4 score = = summary (points for relevant items) average score = = (total score) / (number of items) Interpretation: minimum total score: 0 maximum total score: 96 minimum pain subscore: 0 maximum pain subscore: 20 minimum stiffness subscore: 0 maximum stiffness subscore: 8 minimum physical function subscore: 0 maximum physical function subscore: 6
Disability of Arm, Shoulder and Hand [DASH]
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Change in DASH score The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability A minimum score is 30; a maximum is 150. The range of the scores, therefore-from 30 to 150-equals 120. The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.
The Constant-Murley score (CMS)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Change in CMS. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
Visual Analog Scale (VAS)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control The VAS is a commonly used tool in health outcome studies, when using it to assess importance of certain action or intervention, how we can interpret the results, on 1 to 10 line (where 1; the least and the 10; the highest),
7 secondary outcomes
1. Nature, incidence and severity of adverse events (AEs)
Time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
2. Change in radiographic/magnetic resonance joint morphology
Time frame: Baseline, and 12 months post-treatment cycle
3. Change in cartilage thickness
Time frame: Baseline, and 12 months post-treatment cycle
4. Change in cartilage volume
Time frame: Baseline, and 12 months post-treatment cycle
5. Change in cartilage morphology
Time frame: Baseline, and 12 months post-treatment cycle
6. Change in subchondral bone morphology
Time frame: Baseline, and 12 months post-treatment cycle
8. Inflammation monitoring
Time frame: Baseline, and 12 months post-treatment cycle]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- 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.
Marek Postula, MD, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intraarticular injection of WJMSC in people with Osteoarthritis and Hip Osteoarthritis, run by Medical University of Warsaw at 1 site in Poland.
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 8 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Poland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Postula, MD, PhD (+48605113346, mpostula@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS) (time frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]). The study lists 9 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 8 Mar 2019.