Consider participating in a clinical trial evaluating the safety and effectiveness of MACI, your own cartilage cells placed on a collagen membrane made from pig tissue, compared to Bone Marrow Stimulation (BMS) in the treatment of participants with painful cartilage or cartilage-and-bone injuries in the ankle.
The MASCOT Clinical Trial is looking at the safety and effectiveness of MACI for treating symptomatic chondral or osteochondral lesions of the ankle (painful cartilage or cartilage-and-bone injuries in the ankle) compared with a standard arthroscopic procedure called Bone Marrow Stimulation (BMS). MACI is a surgical treatment that has been approved by the US FDA since 2016 for the repair of similar cartilage defects in the adult knee. However, the use of MACI for the repair of cartilage damage in the ankle is investigational and is not approved by the US FDA or elsewhere.
The study is randomized and open-label, meaning the doctor and participant will know which treatment has been assigned after an ankle arthroscopy and ankle cartilage biopsy. If you qualify and choose to participate, there is a 67% chance you will receive MACI treatment and a 33% you will receive arthroscopic BMS treatment. All study-related treatment is covered at no cost.
If you qualify and choose to participate, you will be in this study for approximately 30 months, which will include a screening period, a treatment period, and a follow-up period. The study will require approximately 10 in-clinic visits depending upon study treatment assignment. If you qualify and choose to participate, you may be compensated for your study-related time and travel. Your participation is entirely voluntary, and you can leave the study at any time.
For more information, please see ClinicalTrials.gov (NCT 06915233).
Those who qualify and choose to participate could:
Support research on the safety and effectiveness of MACI compared to Bone Marrow Stimulation (BMS) for painful ankle cartilage injuries
Improve future treatment options for people with similar ankle injuries
Leave the study at any time - your participation is entirely voluntary
A research study or clinical trial is the process a potential new drug, device, procedure, or process goes through to prove that it is safe, tolerable and effective for the condition it is being studied for. Research studies are the only way to advance medicine for future generations.
Each study has its own set of inclusion and exclusion criteria that a participant must meet before they are allowed to participate in a study. Patients from all backgrounds and walks of life are encouraged to participate.
Every participant in every research study must go through the informed consent process. During this, the trial doctor and research team go over what will happen in the study, what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the study. Participants may withdraw their consent and discontinue the study at any time for any reason.
If studies do not include diverse participants, we cannot know if treatments work for everyone who needs them. Studies only tell researchers how something works for the participants of that study, and they may not work the same in people of different races, ethnicities, ages, or sexes.
All research studies must follow federal laws and ethical guidelines, including HIPAA. Studies must also be approved by an expert group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.