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

NCT ID: NCT05158933

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2025-04-03

Brief Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Ovarian Failure

Detailed Description

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Ovarian Failure. Patients will receive a single intravenous infusion of UC-MSCs as well as a transvaginal ultrasound guided injection of UC-MSCs into the Ovarian Niche, with sedation if needed. The total dose will be approximately 1 million cells per kilogram for the intravenous infusion and 25 million cells injected into the Ovarian Niche. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Conditions

Ovarian Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group (AlloRx)

Single intravenous infusion of 100 million cells

Group Type: EXPERIMENTAL

AlloRx

Intervention Type: BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Interventions

AlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Ovarian Failure
• Understanding and willingness to sign a written informed consent document

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chadwick Prodromos, MD

Role: PRINCIPAL_INVESTIGATOR

The Foundation for Orthopaedics and Regenerative Medicine

Locations

Medical Surgical Associates Center

St John's, , Antigua and Barbuda

Countries

Antigua and Barbuda

Other Identifiers

ATG-2-MSC-012

Identifier Type: -

Identifier Source: org_study_id