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NCT06915233 · ClinicalTrials.gov registry record · Phase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
A Phase 3 study of Chondral Defect and Articular Cartilage Defect, sponsored by Vericel Corporation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
- 4
- Study locations
NCT06915233: Recruiting Phase 3 study of Chondral Defect and Articular Cartilage Defect, sponsored by Vericel Corporation.
NCT06915233 is a Phase 3 study of Chondral Defect and Articular Cartilage Defect that is actively recruiting participants, run by Vericel Corporation. The registered enrollment target is 309 participants, above the 202-participant average among 3 other Chondral Defect trials with a reported enrollment target (53% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06915233, a Phase 3 study of Chondral Defect and Articular Cartilage Defect, is actively recruiting participants, sponsored by Vericel Corporation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme sym
Conditions Studied
Interventions
- BIOLOGICAL autologous cultured chondrocytes on porcine collagen membrane
- PROCEDURE Bone Marrow Stimulation
Study Locations (4)
Texas
- NextStage Clinical Research Houston - All American Orthopedic and Sports Medicine - Houston
- NextStage Clinical Research San Antonio - San Antonino Podiatry Associates - San Antonio
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Kansas
- NextStage Clinical Research Wichita - Kansas Joint and Spine specialists - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2026-03 |
| Est. Completion | 2030-07 |
| Phase | Phase 3 |
What NCT06915233 shows while recruiting
NCT06915233 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 3 other Chondral Defect trials with a reported enrollment target (53% higher).
The record links to 2 conditions, with Chondral Defect appearing as the primary indexed condition, and to 2 interventions - of which autologous cultured chondrocytes on porcine collagen membrane is the first listed.
NCT06915233 reports a single indexed study location in Texas, District of Columbia, Kansas.
Frequently Asked Questions
What is clinical trial NCT06915233 about?
NCT06915233 is a clinical study titled "A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle". 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.
What is the current status of trial NCT06915233?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2026-03. Estimated completion is 2030-07.
What conditions does trial NCT06915233 study?
This clinical trial studies the following conditions: Chondral Defect, Articular Cartilage Defect.
What interventions are being tested in trial NCT06915233?
The interventions under investigation include: autologous cultured chondrocytes on porcine collagen membrane (BIOLOGICAL), Bone Marrow Stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT06915233?
This trial is sponsored by Vericel Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06915233 being conducted?
This trial has 4 study locations across District of Columbia, Kansas, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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