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Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.

Study acronym: ENCANTO
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 4 of 11 sitesv7
  2. Primary endpoint revised
    • Secondary endpoints: details revised at 1 of 11 entries
    • Site details revised at 2 of 11 sites
    v6
  3. Start date: Apr 2025 to Jul 15, 2025
    • Eligibility criteria expanded, about 107 words
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 11 of 11 sites
    v4
  5. Start date: Jan 2025 to Apr 2025v3
  6. Study sites: 10 to 11v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA. The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.
Trial Details
NCT Number NCT06576583
Lead Sponsor University Hospital, Basel, Switzerland
Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland, Wuerzburg University Hospital, Medical University of Vienna, Videoreha, University of Oulu, Theracell Laboratories, Promove-Biotec GmbH, Maastricht University, Foundation National Reumafonds, Angry@Arthritis, University of Miami, Geistlich Pharma AG, European Union
Conditions
(from sponsor)		 Patellofemoral Osteoarthritis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov