Actively Recruiting
A Prospective, Open-label, Randomized, Active-controlled Phase 3 Study of MACI for Symptomatic Chondral or Osteochondral Lesions of the Talus
Led by Vericel Corporation · Updated on 2026-05-27
309
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of MACI, which involves autologous cultured chondrocytes on a porcine collagen membrane, compared to Bone Marrow Stimulation for treating patients aged 17 to 65 with symptomatic cartilage or bone defects in the ankle. This phase 3, open-label clinical trial aims to demonstrate whether MACI is superior to Bone Marrow Stimulation in improving ankle function and pain over two years. The study enrolls about 309 participants randomly assigned in a 2:1 ratio to receive either MACI or Bone Marrow Stimulation. Eligible participants must have at least one cartilage lesion of 1.2 cm² or larger on the talus. After initial screening and ankle arthroscopy, a cartilage biopsy is taken. Those assigned to MACI undergo implantation surgery 5 to 12 weeks later, while those in the Bone Marrow Stimulation group receive treatment during arthroscopy. Both groups follow recommended rehabilitation programs. Participants will have follow-up visits to assess safety at weeks 6 and 12, and for both safety and efficacy at weeks 24, 36, 52, 78, and 104 after treatment. Researchers will monitor pain, function, symptoms, daily living ability, and quality of life using the FAOS questionnaire. Rehabilitation progress is tracked through the first year. The total study period for each participant spans two years from treatment to final assessments.
CONDITIONS
Brief Title
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 17 to 65 years at the time of planned randomization
- One or more symptomatic chondral or osteochondral lesions with FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50
- ICRS Grade 3 or 4 lesions on the talus, including talar neck, suitable for surgery
- At least one lesion ≥ 1.2 cm² in size
- Written informed consent and assent as required
- Will refrain from NSAIDs for 12 weeks after treatment, except low-dose aspirin
- Will limit pain medication to over-the-counter analgesics after 12 weeks post-treatment
- Satisfactory blood counts and kidney function as defined by study parameters
You will not qualify if you...
- Lesions with bone defect depth > 5 mm
- Surgery on target ankle within 24 weeks prior to initial visit (excluding diagnostic arthroscopy)
- Use of investigational drugs, biologics, or devices within 12 weeks prior to initial visit
- Avascular necrosis of target ankle
- Symptomatic musculoskeletal conditions in lower limbs affecting ankle assessment
- Bipolar (kissing) lesions or bilateral ankle lesions
- Lesions requiring osteotomy for MACI implantation
- Systemic inflammatory or joint-affecting diseases such as rheumatoid arthritis or psoriasis
- Advanced or severe osteoarthritis of the ankle
- Septic arthritis in target ankle within 1 year prior to initial visit
- Current or recent malignancy within 5 years (except non-melanoma skin cancer)
- Known allergies to gentamicin, aminoglycosides, or porcine/bovine products
- Female participants who are pregnant or lactating
- Significant medical or psychosocial problems impacting surgery or compliance
- Injection of hyaluronic acid, platelet-rich plasma, or corticosteroids in target ankle within 90 days prior to initial visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 8 weeks after screening
Participants undergo an index ankle arthroscopy to assess eligibility and receive either Bone Marrow Stimulation or a cartilage biopsy for MACI preparation.
1 visit (in-person)
Duration - 5 to 12 weeks after ankle arthroscopy
Participants randomized to MACI return for the MACI implantation surgery. Participants receive either MACI implantation or Bone Marrow Stimulation as their assigned treatment, followed by a recommended postoperative rehabilitation program.
1 visit for MACI implantation; Bone Marrow Stimulation occurs during the arthroscopy visit
Duration - Up to 2 years after treatment
Participants are monitored for safety and efficacy, and their rehabilitation status is assessed through scheduled visits.
Visits at Weeks 6, 12, 24, 36, 52, 78, and 104
Trial Site Locations
Total: 4 locations
1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Elevate Clinical Research Wichita - Kansas Joint and Spine specialists
Wichita, Kansas, United States, 67226
Actively Recruiting
3
Elevate Clinical Research Houston - All American Orthopedic and Sports Medicine
Houston, Texas, United States, 77058
Actively Recruiting
4
San Antonino Podiatry Associates
San Antonio, Texas, United States, 78251
Actively Recruiting
Research Team
V
Vericel Clinical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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