NCT05016817

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• 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 Idiopathic pulmonary fibrosis

Detailed description

Studies have shown that stem cell treatment is safe for Idiopathic pulmonary fibrosis (IPF) and can improve the prognosis of afflicted patients. Patients with IPF will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. 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 requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

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

Timeline

• Start date: 2022-07-03
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2021-08-23
• Last updated: 2025-04-17

Locations

1 site across 1 country: Antigua and Barbuda

Regulatory

• FDA-regulated drug study