Actively Recruiting
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Led by Vericel Corporation · Updated on 2026-03-06
309
Participants Needed
4
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 at the time of planned randomization visit
- One or more symptomatic chondral or osteochondral lesions with FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50
- ICRS Grade 3 or 4 lesion(s) located on the talus, including shoulder lesions, suitable for assigned surgical treatment
- At least one lesion measuring 1.2 cm² or larger
- Written informed consent and assent per Institutional Review Board requirements
- Will refrain from using NSAIDs for 12 weeks after study treatment (low-dose aspirin allowed)
- Will limit pain medication to over-the-counter analgesics after 12 weeks post-treatment
- Hematocrit ≥ 30.0%, White Blood Cell count ≤ 14,000 cells/µL, Platelet Count ≥ 50,000 platelets/µL, Creatinine ≤ 2.0 mg/dL, INR ≤ 1.6
You will not qualify if you...
- Lesions with underlying bone defect deeper than 5 mm
- Surgery on the target joint within 24 weeks prior to initial visit (excluding diagnostic arthroscopy)
- Use of investigational drug, biologic, or device within 12 weeks prior to visit
- Avascular necrosis of the target ankle
- Musculoskeletal conditions in lower limbs that affect ankle measurement
- "Kissing lesions" (bipolar lesions involving tibia and talus) or bilateral ankle lesions
- Lesions requiring osteotomy for MACI implantation
- Systemic inflammatory or joint diseases (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
- History of advanced or severe ankle osteoarthritis (bone on bone or equivalent radiographic evidence)
- Known septic arthritis in the target ankle within 1 year prior to visit
- Current malignancy or treatment for malignancy within past 5 years (except non-melanoma skin cancer)
- Known hypersensitivity to gentamicin, aminoglycosides, or porcine/bovine products
- Females who are pregnant or lactating
- Significant medical or psychosocial issues that affect surgery, rehabilitation, or compliance
- Abnormal screening blood work exceeding 1.5 times upper or below 0.5 times lower normal limits
AI-Screening
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Trial Site Locations
Total: 4 locations
1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
NextStage Clinical Research Wichita - Kansas Joint and Spine specialists
Wichita, Kansas, United States, 67226
Actively Recruiting
3
NextStage Clinical Research Houston - All American Orthopedic and Sports Medicine
Houston, Texas, United States, 77058
Actively Recruiting
4
NextStage Clinical Research San Antonio - San Antonino Podiatry Associates
San Antonio, Texas, United States, 78251
Actively Recruiting
Research Team
V
Vericel Clinical Affairs
CONTACT
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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