Study of MACI for Ankle Cartilage Defects
This study is testing two treatments for painful cartilage or bone and cartilage (osteochondral) defects in the ankle bone (talus). Researchers want to see if MACI (autologous cultured chondrocytes on porcine collagen membrane) works better than Bone Marrow Stimulation. MACI uses your own cartilage cells grown on a special membrane, while Bone Marrow Stimulation involves making small holes in the bone to encourage healing. You might be able to join if you are 17 to 65 years old and have painful ankle cartilage defects. The main goal is to see how much your pain and ankle function improve over 104 weeks (about two years) with each treatment. The study is currently recruiting participants.
- Study design
- This is a 2-year study with 309 participants, aged 17 to 65, who will be randomly assigned to receive either MACI or Bone Marrow Stimulation. It is an open-label study, meaning both you and your doctor will know which treatment you receive.
- What's involved
- You will have an initial screening visit, followed by an ankle arthroscopy (a type of surgery) within 8 weeks to check your eligibility and take a cartilage biopsy. If eligible, you will receive one treatment and follow a recommended rehabilitation program.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 104 weeks (about two years) after treatment to assess changes in pain and function.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
At a glance
Conditions
NCT06915233
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke Orthopaedic Surgery
Durham, North Carolinastudy coordinator listed
Recruiting
Elevate Clinical Research
Houston, Texasstudy coordinator listed
Recruiting
Elevate Clinical Research Wichita
Wichita, Kansasstudy coordinator listed
Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbiastudy coordinator listed
Recruiting
Rodaro, LLC
San Antonio, Texasstudy coordinator listed
Recruiting
UC Davis Foot and Ankle Clinic
Sacramento, Californiastudy coordinator listed
Recruiting
University of Virginia
Charlottesville, Virginiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jonathan Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB · STUDY_CHAIR · Vericel Corporation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scoresBaseline to Week 104
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 symptoms and 100 no symptoms. Selection of this composite primary endpoint is consistent with FDA guidance recommending selection of primary endpoints that evaluate changes in Pain and Function (SRA) subscale scores as they represent clinically meaningful outcomes for participants who receive products intended to repair or replace damaged cartilage in the knee.