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A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

Study acronym: MASCOT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 4 → 7 locations
    • Start date changed from estimate of May 2026 to May 28, 2026
    • Study description revised
    v6
  2. Start date: Mar 2026 to May 2026v5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints revised (2)
    • Study sites revised (4)
    • Study description expanded, about 5 words
  3. Start date: Dec 2025 to Mar 2026
    • Study sites: 1 to 4
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2025 to Dec 2025
    • Study sites: 0 to 1
    • Primary and study completion dates: Apr 2030 to Jul 2030
    v3
  5. Start date: Jul 2025 to Sep 2025v2 Show 4 more changesShow less
    • Enrollment target: 276 to 309
    • Primary and study completion dates: Feb 2030 to Apr 2030
    • Eligibility criteria expanded, about 101 words
    • Study description revised
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06915233
Lead Sponsor Vericel Corporation
Conditions
(from sponsor)		 Chondral Defect, Articular Cartilage Defect
Related terms Bone Diseases, Cartilage Diseases, Connective Tissue Diseases, Musculoskeletal Diseases, Osteochondritis
Enrollment 309 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov