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NCT Number: NCT06143527

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases PCOS Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Medical Surgical Associates Center, St John's, Antigua and Barbuda

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AlloRx

Biological

Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Primary outcomes

  1. Safety: Adverse Events

    Time frame: Four year follow-up

    Clinical monitoring of possible adverse events or complications

Secondary outcomes

  1. Efficacy: Global Improvement Score (GI)

    Time frame: Four year follow-up

    Ranging from 0 to 100%

Study contacts

Contact information is provided by the study sponsor or research team.

Chadwick C Prodromos, MD

CONTACT

[email protected]

8476996810

Sponsors and collaborators

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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