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

Last updated: April 15, 2025
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Impotence

Peyronie's Disease

Gynecological Infections

Treatment

AlloRx

Clinical Study ID

NCT05147779
ATG-1-MSC-015
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Peyronie's Disease, erectile dysfunction, or Interstitial Cystitis

  • Understanding and willingness to sign a written informed consent document

Exclusion

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) compromisepatient's safety.

  • Continued drug abuse

  • Pre-menopausal women not using contraception

  • Previous organ transplant

  • Hypersensitivity to sulfur

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: AlloRx
Phase: 1
Study Start date:
September 12, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Medical Surgical Associates Center

    St. John's,
    Antigua and Barbuda

    Active - Recruiting

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