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

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT06143527

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome (PCOS) Polycystic Ovary Syndrome PCOS	Biological: AlloRx	Phase 1

Detailed Description

Stem cell treatment has shown efficacy for PCOS in both human and animal studies. We are also reporting completer resolution of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). We 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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2023

Anticipated Primary Completion Date :

Nov 16, 2027

Anticipated Study Completion Date :

Nov 16, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment Group (AlloRx)

Intravenous infusion

Biological: AlloRx

Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Outcome Measures

Primary Outcome Measures

Safety: Adverse Events [Four year follow-up]
Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

Efficacy: Global Improvement Score (GI) [Four year follow-up]
Ranging from 0 to 100%

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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