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

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Ovarian Failure

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05158933

Enrollment

Registered

2021-12-15

Start date

2025-04-03

Completion date

2025-04-03

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Failure

Keywords

Ovarian Failure, stem cell treatment

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.

Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Countries

Antigua and Barbuda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026