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

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Peyronie's Disease, Erectile Dysfunction, and Interstitial Cystitis

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05147779

Enrollment

Registered

2021-12-07

Start date

2021-09-12

Completion date

2025-12-31

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Interstitial Cystitis, Peyronie's Disease

Keywords

Erectile Dysfunction, Peyronie's Disease, stem cell treatment, Interstitial Cystitis

Brief summary

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

Detailed description

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.

Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Countries

Antigua and Barbuda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026