Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
Celltex Therapeutics Corporation
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age above 18 years * Male or female * Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage) * Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures * Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination. Exclusion Criteria: * Participation in another clinical study (with use of another Investigational Medical Product)…
Interventions
- BiologicalCelltex- AdMSCs
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Location
- Stanley C JonesHouston, Texas