This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Stanley C Jones
Houston, Texas, United States
the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.
safety
Time frame: 12 months
Any organ damage or safety concerns determined by SMAC 20 blood test.
Safety
Time frame: 12 months
Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
efficacy
Time frame: 12 months
Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
efficacy
Time frame: 12 months
Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
efficacy
Time frame: 12 months
Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
efficacy
Time frame: 12 months
Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
efficacy
Time frame: 12 month
Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
efficacy
Time frame: 12 months
changes in joint images (X-ray or MRI) from the baseline
efficacy
Time frame: 12 months
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