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NCT06143527 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06143527
Other study ID # 2023MSC-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 16, 2023
Est. completion date November 16, 2027

Study information
Verified date November 2023
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact Chadwick C Prodromos, MD
Phone 8476996810
Email research@ismoc.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 16, 2027
Est. primary completion date November 16, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• AlloRx
Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations
Country Name City State
Antigua and Barbuda Medical Surgical Associates Center St. John's
Greece Athens Beverly Hills Medical Group Glyfáda

Sponsors (1)
Lead Sponsor Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Countries where clinical trial is conducted

Antigua and Barbuda,  Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: Adverse Events Clinical monitoring of possible adverse events or complications Four year follow-up
Secondary Efficacy: Global Improvement Score (GI) Ranging from 0 to 100% Four year follow-up
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Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
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Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A