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

NCT05147779 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ATG-1-MSC-015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Erectile Dysfunction; Peyronie's Disease; Interstitial Cystitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events)

  Clinical monitoring of possible adverse events or complications

  Four year follow-up

Study Arms (1)

Treatment Group (AlloRx)

EXPERIMENTAL

intravenous and intracavernosal or interstitial delivery (total dose of 100 million cells)

Biological: AlloRx

Interventions

AlloRx BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group (AlloRx)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Peyronie's Disease, erectile dysfunction, or Interstitial Cystitis
• Understanding and willingness to sign a written informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• The Foundation for Orthopaedics and Regenerative Medicine: lead

Study Sites (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Related Publications (3)

• Al Demour S, Jafar H, Adwan S, AlSharif A, Alhawari H, Alrabadi A, Zayed A, Jaradat A, Awidi A. Safety and Potential Therapeutic Effect of Two Intracavernous Autologous Bone Marrow Derived Mesenchymal Stem Cells injections in Diabetic Patients with Erectile Dysfunction: An Open Label Phase I Clinical Trial. Urol Int. 2018;101(3):358-365. doi: 10.1159/000492120. Epub 2018 Aug 31.

  PMID: 30173210 BACKGROUND

• Bahk JY, Jung JH, Han H, Min SK, Lee YS. Treatment of diabetic impotence with umbilical cord blood stem cell intracavernosal transplant: preliminary report of 7 cases. Exp Clin Transplant. 2010 Jun;8(2):150-60.

  PMID: 20565373 BACKGROUND

• Levy JA, Marchand M, Iorio L, Zribi G, Zahalsky MP. Effects of Stem Cell Treatment in Human Patients With Peyronie Disease. J Am Osteopath Assoc. 2015 Oct;115(10):e8-13. doi: 10.7556/jaoa.2015.124.

  PMID: 26414724 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction; Penile Induration; Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Penile Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Chadwick Prodromos, MD

  The Foundation for Orthopaedics and Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 7, 2021
• Study Start: September 12, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)