Study of Umbilical Cord Stem Cell Therapy for Peyronies Disease, Erectile Dysfunction, and Interstitial Cystitis Assessing Safety and Effectiveness of Intravenous and Local Stem Cell Delivery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs delivered intravenously and directly into the penis or bladder area. This trial focuses on treating Peyronies disease, erectile dysfunction, and interstitial cystitis. It is a phase 1 patient-funded study sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Participants will receive a total dose of 100 million stem cells delivered through intravenous and intracavernosal or interstitial injections. The study involves one treatment group receiving the AlloRx stem cell therapy. Patients are assessed before treatment and then at 1, 6, 12, 24, 36, and 48 months after to monitor safety and treatment effects over four years. During the trial, participants will undergo evaluations including laboratory tests and safety checks at multiple time points up to four years post-treatment. The primary outcome measure is the recording of any adverse events throughout the four-year follow-up. Researchers will assess both safety and efficacy of the stem cell therapy by observing participants health and responses over this extended period.

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis