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

The Foundation for Orthopaedics and Regenerative Medicine

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Ovarian Failure

Interventions

AlloRxBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Outcomes

Primary Outcomes

Safety (adverse events)

Clinical monitoring of possible adverse events or complications

Time frame: Four year follow-up

Data from ClinicalTrials.gov

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