An Open Label Study to Evaluate Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
Akan Biosciences, LLC
Summary
The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.
Eligibility
- Age range
- 25–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults between the ages of 25-65 years 2. Body Mass Index (BMI) less than 40 kg/m2 3. Ambulatory and in good general health as described by vital signs (blood pressure 90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1 °F) and normal blood chemistry. 4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days 5. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) within the last 6 months 6. Minimum score of 40 out of…
Interventions
- BiologicalStroMel
Autologous MSC
Location
- MukeshGaithersburg, Maryland