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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase

Enrolling

Phase 1

Conditions

PCOS

Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS)

Treatments

Biological: AlloRx

Study type

Interventional

Funder types

Other

Identifiers

NCT06143527

2023MSC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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