Recruiting
Phase 1

Mesenchymal Stem Cells

Sponsor:

The Foundation for Orthopaedics and Regenerative Medicine

Code:

NCT06143527

Conditions

Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome

PCOS

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

Study Details

Brief summary:

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Conditions

Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome

PCOS

Study ID

NCT06143527

Start date

Nov 16, 2023

Status verified date

Oct, 2026

Completion date

Nov 16, 2027

Anticipated

Primary completion date

Nov 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Intravenous infusion

Interventions

Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

Primary outcome measure

  • Safety: Adverse Events [ Time Frame: Four year follow-up ]

Central Contacts and Locations

Central contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

Locations

Prodromos Stem Cell Institute

Recruiting

Naples, Florida, United States, 34102

Contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

More Information

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by The Foundation for Orthopaedics and Regenerative Medicine on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.