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A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study sites revised (14)
  2. Study sites: 12 to 14
    • Eligibility criteria expanded, about 11 words
    v16
  3. Primary and study completion dates: Jun 2027 to Feb 2030v15 Show 4 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 409 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 1 word
  4. Site details revised at 2 of 12 sitesv14
  5. Site details revised at 2 of 12 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary and study completion dates: Jun 2025 to Jun 2027
    • Site details revised at 1 of 12 sites
    v12
  2. Eligibility criteria shortened, about 9 words
    • Study sites revised (12)
    v11
  3. Site details revised at 3 of 12 sitesv10
  4. Study sites: 10 to 12v9
  5. Re-verified, no change to tracked fieldsv8
  6. Site details revised at 2 of 10 sitesv7
  7. Site details revised at 1 of 10 sitesv6
  8. Study sites: 11 to 10
    • Study description revised
    • Study title revised
    v5
  9. Site details revised at 1 of 11 sitesv4
  10. Start date changed from estimate of Oct 2018 to Oct 24, 2018
    • Site details revised at 2 of 11 sites
    v3
  11. Start date: Jul 2018 to Oct 2018
    • Study sites: 12 to 11
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
Trial Details
NCT Number NCT03588975
Lead Sponsor Vericel Corporation
Conditions
(from sponsor)		 Chondral Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Defect, Articular Cartilage Disorder of Knee
Related terms Osteochondritis Dissecans
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov