Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

April 4, 2025 updated by: The Foundation for Orthopaedics and Regenerative Medicine

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stem cell treatment has shown efficacy for PCOS in both human and animal studies. Complete resolution was seen of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). It is hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Antigua and Barbuda
      • St. John's, Antigua and Barbuda
        • Recruiting
        • Medical Surgical Associates Center
        • Contact:
          • Chadwick C Prodromos, MD
  • Greece
      • Glyfáda, Greece, 16675
        • Recruiting
        • Athens Beverly Hills Medical Group
        • Contact:
          • Chadwick C Prodromos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Ultrasound documented poly cystic ovary syndrome

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
  • Previous organ transplant
  • Hypersensitivity to sulfur
  • Inability to supply proper informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group (AlloRx)
Intravenous infusion
Biological: AlloRx
Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Adverse Events
Time Frame: Four year follow-up
Clinical monitoring of possible adverse events or complications
Four year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Global Improvement Score (GI)
Time Frame: Four year follow-up
Ranging from 0 to 100%
Four year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Investigators

  • Principal Investigator: Chadwick C Prodromos, MD, The Foundation for Orthopaedics and Regenerative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Estimated)

November 16, 2027

Study Completion (Estimated)

November 16, 2027

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023MSC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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