NCT06143527

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
19mo left

Started Nov 2023

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Nov 2023Nov 2027

First Submitted

Initial submission to the registry

November 16, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

November 16, 2023

Last Update Submit

April 4, 2025

Conditions

Polycystic Ovary Syndrome (PCOS)Polycystic Ovary SyndromePCOS

Keywords

Polycystic Ovary Syndrome (PCOS)Polycystic Ovary SyndromePCOSStem CellStem CellsMesenchymal Stem CellsUmbilical Cord Derived Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

  • Safety: Adverse Events

    Clinical monitoring of possible adverse events or complications

    Four year follow-up

Secondary Outcomes (1)

  • Efficacy: Global Improvement Score (GI)

    Four year follow-up

Study Arms (1)

Treatment Group (AlloRx)

EXPERIMENTAL

Intravenous infusion

Biological: AlloRx

Interventions

AlloRxBIOLOGICAL

Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group (AlloRx)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ultrasound documented poly cystic ovary syndrome

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Athens Beverly Hills Medical Group

Glyfada, 16675, Greece

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Chadwick C Prodromos, MD

    The Foundation for Orthopaedics and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chadwick C Prodromos, MD

CONTACT

8476996810research@ismoc.net

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 16, 2023

First Posted

November 22, 2023

Study Start

November 16, 2023

Primary Completion (Estimated)

November 16, 2027

Study Completion (Estimated)

November 16, 2027

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

AN(1)GR(1)