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.
Adults between the ages of 25-65 years
Body Mass Index (BMI) less than 40 kg/m2
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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days
Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
Subject with an infection that requires parenteral antibiotic administration.
Active infection or crystal disease in the index joint within 1 month of screening
History of fracture in the index limb, joint instability, or history of acute dislocation within 12 months of screening, or fracture with sequelae at any time
Single group
StroMel
Biological/VaccineAutologous MSC
Safety of StroMel in subjects with moderate to severe OA of the kneee
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 StroMel
Summary of all study related AEs and SAEs.
Efficacy of StroMel in managing OA of the knee
Reduction of NSAIDS, until study completion
Efficacy of StroMel in assessment of OA of the knee post-treatment
Percent change from baseline in rating scales (WOMAC and VAS assessments)
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This trial is not recruiting at the moment. You can still explore other options:
