NCT05158933

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Foundation for Orthopaedics and Regenerative Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	AlloRx	cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Timeline

• Start date: 2025-04-03
• Primary completion: 2025-04-03
• Completion: 2025-04-03
• First posted: 2021-12-15
• Last updated: 2025-04-06

Locations

1 site across 1 country: Antigua and Barbuda

Regulatory

• FDA-regulated drug study