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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06143527

Enrollment

Registered

2023-11-22

Start date

2023-11-16

Completion date

2027-11-16

Last updated

2025-04-08

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

Conditions

PCOS, Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome, PCOS, Stem Cell, Stem Cells, Mesenchymal Stem Cells, Umbilical Cord Derived Mesenchymal Stem Cells

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.

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.

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

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Antigua and Barbuda, Greece

Contacts

Primary ContactChadwick C Prodromos, MD

research@ismoc.net8476996810

Outcome results

None listed

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