Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Peyronie's Disease, Erectile Dysfunction, and Interstitial Cystitis
| Registry | NCT05147779 |
|---|---|
| Status | Terminated - Inadequate treatment response observed in preliminary data did not justify enrolling further study participants |
| Phase | Phase 1 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine (Other) |
| Conditions | Erectile Dysfunction, Peyronie's Disease, Interstitial Cystitis |
| Interventions | AlloRx (Biological) |
| Dates | start 2021-09-12, primary completion 2025-12-30, completion 2025-12-30, first posted 2021-12-07, last updated 2026-10-20 |
| Locations | 1 site in Antigua and Barbuda |
Related Papers Related Patents Related Grants Related Experts
All trials for Erectile Dysfunction All trials for Peyronie's Disease All trials of AlloRx
This trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis
This patient funded trial aims to study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment Group (AlloRx) | Experimental | Biological: AlloRx | intravenous and intracavernosal or interstitial delivery (total dose of 100 million cells) |
Sex: All
Inclusion Criteria: * Diagnosis of Peyronie's Disease, erectile dysfunction, or Interstitial Cystitis * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur
| Facility | City | Country | Status |
|---|---|---|---|
| Medical Surgical Associates Center | St John's | Antigua and Barbuda |