Safety of Cultured Allogeneic Adult Umbilical Cord Derive... | NCT06143527

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

NCT06143527

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Status

Recruiting

Last Update Posted

Apr 8, 2025Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
PCOS

Interventions

AlloRx

Countries

Antigua and Barbuda
Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2023Actual

Primary Completion Date

Nov 16, 2027Estimated

Completion Date

Nov 16, 2027Estimated

First Submitted Date

Nov 16, 2023

First Submission Date that Met QC Criteria

Nov 16, 2023

First Posted Date

Nov 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group (AlloRx)	Experimental	Intravenous infusion	Biological: AlloRx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AlloRx	Biological	Cultured allogeneic adult umbilical cord derived mesenchymal stem cells	Treatment Group (AlloRx)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Adverse Events	Clinical monitoring of possible adverse events or complications	Four year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: Global Improvement Score (GI)	Ranging from 0 to 100%	Four year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chadwick C Prodromos, MD	Contact	8476996810		research@ismoc.net

Overall Officials

Name	Affiliation	Role
Chadwick C Prodromos, MD	The Foundation for Orthopaedics and Regenerative Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Surgical Associates Center	Recruiting	St John's			Antigua and Barbuda

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided