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

NCT ID: NCT06143527

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-16

Study Completion Date

2027-11-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome (PCOS) Polycystic Ovary Syndrome PCOS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group (AlloRx)

Intravenous infusion

Group Type EXPERIMENTAL

AlloRx

Intervention Type BIOLOGICAL

Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Interventions

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AlloRx

Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chadwick C Prodromos, MD

Role: PRINCIPAL_INVESTIGATOR

The Foundation for Orthopaedics and Regenerative Medicine

Locations

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Medical Surgical Associates Center

St John's, , Antigua and Barbuda

Site Status RECRUITING

Athens Beverly Hills Medical Group

Glyfada, , Greece

Site Status RECRUITING

Countries

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Antigua and Barbuda Greece

Central Contacts

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Chadwick C Prodromos, MD

Role: CONTACT

8476996810

Facility Contacts

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Chadwick C Prodromos, MD

Role: primary

Chadwick C Prodromos, MD

Role: primary

Other Identifiers

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2023MSC-01

Identifier Type: -

Identifier Source: org_study_id

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