drugset / Trial / NCT05559801
Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bone marrow-derived mesenchymal stromal cells (MSCs) | Cell therapy | — | Intravenous |