Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for Various Chronic and Acute Conditions

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of stem cell therapy for treating a variety of acute and chronic conditions. This multi-site, multi-arm study focuses on regenerative treatments using amniotic and umbilical cord stem cell rich tissue. The study covers conditions including autoimmune diseases, cardiovascular disorders, diabetes complications, integumentary diseases, musculoskeletal disorders, neurological and neurodegenerative disorders, pulmonary disorders, sexual dysfunction, urologic disorders, and viral illnesses. The goal is to measure improvements based on validated quality of life and condition-specific tools. Participants will receive injections of PrimePro™ or PrimeMSK™ stem cell products administered through condition-specific routes. Each study arm targets a particular group of conditions to compare outcomes against established research. The treatments are given once with follow-up visits planned to assess changes over time. No placebo or control group is used, and the study is non-randomized with open-label participation. During the study, participants will undergo various assessments such as the 36-Item Short Form Survey (SF-36) for quality of life, condition-specific questionnaires like the DASH for arm and shoulder disabilities, IIEF-5 for erectile function, clinical COPD questionnaire, MMSE for mental state, O'Leary/Sant questionnaire for interstitial cystitis, Oswestry Low Back Pain Disability Questionnaire, and WOMAC for osteoarthritis. Follow-up evaluations occur at 6 and 12 months after treatment to monitor progress. The study includes safety monitoring and requires participants to be available for follow-up visits over this time frame.

Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions