Chondral DefectPhase 3MASCOTNCT06915233
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
A Phase 3 study testing autologous cultured chondrocytes on porcine collagen membrane and Bone Marrow Stimulation in people with Chondral Defect and Articular Cartilage Defect, run by Vericel Corporation at 12 sites in United States.
Trial summary
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Chondral Defect, Articular Cartilage Defect
- What is being tested?
- autologous cultured chondrocytes on porcine collagen membrane and Bone Marrow Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 12 sitesUnited States
- Study dates
- 28 May 2026to Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 17 to 65 at the time of planned randomization visit (Visit 2).
- One or more symptomatic chondral or osteochondral lesion/s as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50.
- International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral or osteochondral lesion/s located on the talus with or without cysts, including shoulder lesions (lesions on the talar neck), and amenable to treatment with the surgical procedure specified at randomization.
- At least 1 lesion ≥ 1.2 cm².
- Written informed consent and assent (as applicable) per Institutional Review Board (IRB) requirements.
- Participant will refrain from using Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 12 weeks post-study treatment. (Post-surgical use of low-dose aspirin for clot prevention is acceptable).
- Participant will restrict pain medication to over-the-counter analgesics (NSAIDs or acetaminophen/paracetamol) after 12 weeks post-study treatment.
- Participant must have Hematocrit ≥30.0%; White Blood Cell count ≤14,000 cells/μL; Platelet Count ≥50,000 platelets/μL; Creatinine ≤2.0 mg/dL; and International Normalized Ratio (INR) ≤1.6.
Who cannot join
- Lesions with an underlying bony defect depth of > 5 mm.
- Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).
- Previous investigational drug, biologic or device use within 12 weeks prior to Visit.
- Avascular necrosis of the target ankle.
- Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.
- Participant with "kissing lesions" (bipolar lesions, involving both the tibia and talus), or with bilateral lesions in both ankles.
Show all 21Show fewer
- Participant with lesions that require an osteotomy procedure to allow for MACI implantation as determined at the time of ankle arthroscopy (Visit 2).
- Concomitant systemic inflammatory diseases or other conditions that affect the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis).
- History of advanced or severe osteoarthritis of the ankle as determined by prior surgical history confirming no joint space (i.e., "bone on bone") or radiographic evidence of Modified Kellgren-Lawrence Grade 4 arthritis (i.e., osteophytes on lateral and medial malleoli and at the tibiotalar joint margins, narrowing of the joint space width > 50%, and tibiotalar sclerosis), Van Dijk Grade III (i.e., total or subtotal destruction of the joint space) or the equivalent.
- Known history of septic arthritis in the target ankle joint within 1 year prior to Visit 1.
- Current malignancy or treatment for malignancy within the past 5 years prior to Visit 1, excluding non-melanoma skin cancer.
- Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.
- Females who are pregnant or lactating.
- Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:
- Any condition that has potential for negatively impacting intra- or postoperative course (e.g., uncontrolled diabetes, heavy smoking). - Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8.0% and/or fasting plasma glucose >250 mg/dL (13.9 mmol/L) within the last 90 days prior to Screening Visit 1 - Heavy smoking is defined as current smoker with use of ≥20 cigarettes per day (≥1 pack/day) at the time of Screening Visit 1.
- Conditions that limit compliance with rehabilitation program.
- Any condition that has potential for significantly limiting participant's ability to assess postoperative ankle function.
- Any condition, psychiatric or otherwise, that would preclude informed consent/assent, consistent follow-up, or compliance with any aspect of the clinical trial.
- Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance.
- Any abnormal screening blood work that the Investigator deems clinically significant in addition to the parameters delineated in Inclusion Criterion #8.
- Injection of hyaluronic acid (HA), platelet-rich plasma (PRP), and/or corticosteroids in the target ankle within 90 days prior to Visit 1.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Castro Valley Care Center
Castro Valley, California, 94546
Canary Jumawan, 510-204-1610, canary.jumawan@sutterhealth.org
Deryk Jones
- Recruiting
UVA Orthopedic Center Ivy Road
Charlottesville, Virginia, 22903
Eric McVey, 434-243-5382, EDM9U@uvahealth.org
Minton Truitt Cooper, MD
- Recruiting
Duke Orthopaedic Surgery
Durham, North Carolina, 27705
Suzanne Finley, 919-684-5431, suzanne.finley@duke.edu
Annunziato Amendola, MD
- Recruiting
Orthopedic Specialists of North America, PLLC d/b/a OrthoArizona - South Gilbert
Gilbert, Arizona, 85297
Study Recruitment Team, 800-774-1534, recruitment@prgresearch.com
Kipling P. Sharpe
- Recruiting
Elevate Clinical Research
Houston, Texas, 77058
Tara Bocquet, 8322252937, tara.bocquet@elevateclinical.com
Jesus Juarez, MD
- Recruiting
University of Pittsburgh Medical Center Freddie Fu Sports Medicine Center
Pittsburgh, Pennsylvania, 15203
Ting Cong, 412-432-3707, congt@upmc.edu
Ting Cong
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sejal Dave, 507-266-9085, dave.sejal@mayo.edu
Kyle R Duchman
- Recruiting
UC Davis Foot and Ankle Clinic
Sacramento, California, 95816
Leslie Mellor, 916-826-8135, ljmellor@health.ucdavis.edu
Eric Giza, MD
- Recruiting
Rodaro, LLC
San Antonio, Texas, 78251
Carrisa Bolado, 2106898287, Cboladorodarollc@gmail.com
Robert Farber, MD
- Recruiting
The Steadman Clinic
Vail, Colorado, 81657
Sara Robinson, 970-401-8717, srobinson@sprivail.org
Jonathon Backus
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Joshua Lawrence, 240-863-1681, joshua.lawrence@medstar.net
Nicholas Casscells, MD
- Recruiting
Elevate Clinical Research Wichita
Wichita, Kansas, 67226
Tara Bocquet, 8322252937, tara.bocquet@elevateclinical.com
Jon Morgan, MD
About this study
Official title: A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients With Symptomatic Chondral or Osteochondral Lesions of the Talus (MASCOT)
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.
Read the detailed description
This is a 2-year prospective, multicenter, two-arm, parallel-group open-label clinical trial in which a total of 309 subjects, ages 17 to 65, will be randomized 2:1 to receive a 1-time treatment in the ankle with MACI or arthroscopic BMS.
After meeting screening criteria at the initial visit (Visit 1), all participants will have an index ankle arthroscopy within 8 weeks to further assess clinical trial eligibility. During the index ankle arthroscopy (Visit 2), participants will be further evaluated against entry criteria. Cartilage lesion size will be measured before randomization and any cartilage repair procedure. Only participants with at least 1 lesion ≥ 1.2 cm² on the talus will be eligible for inclusion in the clinical trial.
All participants who meet the eligibility criteria and are considered suitable for treatment in the clinical trial by their surgeon will have a cartilage biopsy taken prior to randomization to study treatment. Eligible participants will be randomized 2:1 to receive either MACI or Bone Marrow Stimulation. Participants randomized to Bone Marrow Stimulation will undergo the procedure during the Visit 2 ankle arthroscopy. Subjects will be asked to follow a recommended postoperative rehabilitation program.
All biopsied tissue will be sent to the Vericel Corporation manufacturing facility in Massachusetts, where the sample will be processed to isolate the autologous chondrocytes, undergo cell culture expansion through at least the primary phase, and cryopreservation. Additional expansion of the cells will occur after the MACI implantation surgery has been scheduled.
Participants assigned to the MACI treatment arm will return within 5 to 12 weeks of the Visit 2 ankle arthroscopy to undergo MACI implantation procedure via arthrotomy (Visit 3). Participants will be asked to follow a recommended postoperative rehabilitation program.
All subjects will be assessed post-study treatment at Weeks 6 and 12 for safety and at Weeks 24, 36, 52, 78, and 104 for safety and efficacy. Rehabilitation status will be monitored at all post-treatment visits through Week 52.
- Conditions
- Chondral Defect, Articular Cartilage Defect
- Being tested
- autologous cultured chondrocytes on porcine collagen membrane, Bone Marrow Stimulation
- Keywords
- Bone Diseases, Musculoskeletal Diseases, Connective Tissue Diseases, Osteochondritis, Cartilage Diseases
- Medical subject headings
- Bone Diseases, Musculoskeletal Diseases, Connective Tissue Diseases, Osteochondritis, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous cultured chondrocytes on porcine collagen membraneBiological
An autologous cellularized scaffold combination product being studied for the repair of symptomatic, single or multiple full-thickness cartilage defects of the talus with or without bone involvement in adults.
Bone Marrow StimulationProcedure or surgery
A surgical awl or microdrill will be used to make multiple holes in the exposed base of the lesion. The microfracture procedure should result in holes that are approximately 3 to 4 mm apart.
When fat droplets can be seen coming from the marrow cavity, the appropriate depth (approximately 2 to 4 mm) has been reached.
The released marrow elements (including mesenchymal stem cells, growth factors, and other healing proteins) form a surgically induced clot that provides an enriched environment for new tissue formation.
| Study group | Role | What they receive |
|---|---|---|
| MACI | Experimental | autologous cultured chondrocytes on porcine collagen membrane Receives: Biological: autologous cultured chondrocytes on porcine collagen membrane |
| Bone Marrow Stimulation | Other | Surgical procedure Receives: Procedure: Bone Marrow Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores
The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms.
Selection of this composite primary endpoint is consistent with FDA guidance recommending selection of primary endpoints that evaluate changes in Pain and Function (SRA) subscale scores as they represent clinically meaningful outcomes for participants who receive products intended to repair or replace damaged cartilage in the knee.
Measured: Baseline to Week 104
Secondary outcomes (2)
Percentage of participants who respond to study treatment after 2 years, i.e., participants who have ≥ 10-point improvement on both the FAOS Pain and Function (SRA) subscale scores from Baseline to Week 104.
The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms.
Measured: Baseline to Week 104
Change from Baseline to Week 104 in the remaining FAOS subscales scores [Symptoms, Function (Daily Living) and Quality of Life]
The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms.
Measured: Baseline to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start28 May 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral DefectStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB, Study chair, Vericel Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915233
- Sponsor's protocol ID
- 55-2410-01
- Acronym
- MASCOT
- Status last verified
- Nov 2026
- First submitted
- 1 Apr 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients With Symptomatic Chondral or Osteochondral Lesions of the Talus (MASCOT)
- ClinicalTrials.gov ID
- NCT06915233
- Acronym / sponsor ID
- MASCOT / 55-2410-01
- Conditions
- Chondral Defect, Articular Cartilage Defect
- Keywords
- Bone Diseases, Musculoskeletal Diseases, Connective Tissue Diseases, Osteochondritis, Cartilage Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 8 Apr 2025 (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.
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.
Detailed description
This is a 2-year prospective, multicenter, two-arm, parallel-group open-label clinical trial in which a total of 309 subjects, ages 17 to 65, will be randomized 2:1 to receive a 1-time treatment in the ankle with MACI or arthroscopic BMS.
After meeting screening criteria at the initial visit (Visit 1), all participants will have an index ankle arthroscopy within 8 weeks to further assess clinical trial eligibility. During the index ankle arthroscopy (Visit 2), participants will be further evaluated against entry criteria. Cartilage lesion size will be measured before randomization and any cartilage repair procedure. Only participants with at least 1 lesion ≥ 1.2 cm² on the talus will be eligible for inclusion in the clinical trial.
All participants who meet the eligibility criteria and are considered suitable for treatment in the clinical trial by their surgeon will have a cartilage biopsy taken prior to randomization to study treatment. Eligible participants will be randomized 2:1 to receive either MACI or Bone Marrow Stimulation. Participants randomized to Bone Marrow Stimulation will undergo the procedure during the Visit 2 ankle arthroscopy. Subjects will be asked to follow a recommended postoperative rehabilitation program.
All biopsied tissue will be sent to the Vericel Corporation manufacturing facility in Massachusetts, where the sample will be processed to isolate the autologous chondrocytes, undergo cell culture expansion through at least the primary phase, and cryopreservation. Additional expansion of the cells will occur after the MACI implantation surgery has been scheduled.
Participants assigned to the MACI treatment arm will return within 5 to 12 weeks of the Visit 2 ankle arthroscopy to undergo MACI implantation procedure via arthrotomy (Visit 3). Participants will be asked to follow a recommended postoperative rehabilitation program.
All subjects will be assessed post-study treatment at Weeks 6 and 12 for safety and at Weeks 24, 36, 52, 78, and 104 for safety and efficacy. Rehabilitation status will be monitored at all post-treatment visits through Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACI | Experimental | Biological: autologous cultured chondrocytes on porcine collagen membraneautologous cultured chondrocytes on porcine collagen membrane |
| Bone Marrow Stimulation | Other | Procedure: Bone Marrow StimulationSurgical procedure |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 17 to 65 at the time of planned randomization visit (Visit 2).
- One or more symptomatic chondral or osteochondral lesion/s as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50.
- International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral or osteochondral lesion/s located on the talus with or without cysts, including shoulder lesions (lesions on the talar neck), and amenable to treatment with the surgical procedure specified at randomization.
- At least 1 lesion ≥ 1.2 cm².
- Written informed consent and assent (as applicable) per Institutional Review Board (IRB) requirements.
Key exclusion criteria (21 listed)
- Lesions with an underlying bony defect depth of > 5 mm.
- Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).
- Previous investigational drug, biologic or device use within 12 weeks prior to Visit.
- Avascular necrosis of the target ankle.
- Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.
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 |
|---|---|---|
| autologous cultured chondrocytes on porcine collagen membraneAn autologous cellularized scaffold combination product being studied for the repair of symptomatic, single or multiple full-thickness cartilage defects of the talus with or without bone involvement in adults. | Biological | MACI |
| Bone Marrow StimulationA surgical awl or microdrill will be used to make multiple holes in the exposed base of the lesion. The microfracture procedure should result in holes that are approximately 3 to 4 mm apart. When fat droplets can be seen coming from the marrow cavity, the appropriate depth (approximately 2 to 4 mm) has been reached. The released marrow elements (including mesenchymal stem cells, growth factors, and other healing proteins) form a surgically induced clot that provides an enriched environment for new tissue formation. | Procedure or surgery | Bone Marrow Stimulation |
Primary outcome
Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores
Time frame: Baseline to Week 104
The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms. Selection of this composite primary endpoint is consistent with FDA guidance recommending selection of primary endpoints that evaluate changes in Pain and Function (SRA) subscale scores as they represent clinically meaningful outcomes for participants who receive products intended to repair or replace damaged cartilage in the knee.
2 secondary outcomes
Percentage of participants who respond to study treatment after 2 years, i.e., participants who have ≥ 10-point improvement on both the FAOS Pain and Function (SRA) subscale scores from Baseline to Week 104.
Time frame: Baseline to Week 104
Change from Baseline to Week 104 in the remaining FAOS subscales scores [Symptoms, Function (Daily Living) and Quality of Life]
Time frame: Baseline to Week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- 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.
Jonathan Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB study chair
Vericel Corporation
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing autologous cultured chondrocytes on porcine collagen membrane and Bone Marrow Stimulation in people with Chondral Defect and Articular Cartilage Defect, run by Vericel Corporation at 12 sites 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 8 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vericel Clinical Affairs (978-347-2876, clinicalhotline@vcel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores (time frame: Baseline to Week 104). 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 5 Nov 2026.