StroMel™ for Moderate to Severe Knee Osteoarthritis
This study is looking at the safety of StroMel™, a treatment made from your own cells (autologous MSC), for people with moderate to severe osteoarthritis (OA) of the knee. Researchers want to see if StroMel™ is safe and well-tolerated over 12 months. You might be able to join if you are between 25 and 65 years old, have a BMI (Body Mass Index) less than 40, and are generally healthy. The study is currently unclear about its recruitment status and plans to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Safety of StroMel in subjects with moderate to severe OA of the kneee12 months
Presence of adverse events in less than 10% of the study population. Adverse events assessed will be Grade 4 administrative site infection, Grade 3 hypersensitivity/anaphylaxis, \>20% increase in WOMAC pain score, treatment-related disability, and presence of tumors post-treatment.
- Overall Safety of StroMel12 months
Summary of all study related AEs and SAEs.