drugset / Trial / NCT05559801

Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)

NCT05559801 ↗

Phase 1/2 Not yet recruiting 12 enrolled Emory University
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1/2 study to determine the safety and efficacy of allogeneic (third party), bone-marrow derived mesenchymal stromal cells (MSCs) for the treatment of Osteogenesis Imperfecta (OI) Type 3. It will evaluate this by looking at whether there are treatment related infusion reactions, and assessing linear growth rates and bone health, both of which are impaired in patients ages 3-10 with Osteogenesis Imperfecta Type 3. This is a single-site non-randomized clinical trial, that will take place at Children's Healthcare of Atlanta (CHOA) at Egleston and Emory Children's Center.

Timeline

Start
2027-01
Primary completion
2029-01
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bone marrow-derived mesenchymal stromal cells (MSCs) Cell therapy — Intravenous