drugset / Trial / NCT02172885
Mesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis Imperfecta
Phase 1
Completed
2 enrolled
Hospital de Cruces
Hospital Infantil Universitario Niño Jesús, Madrid, Spain · collabHospital Universitario Getafe · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and effectiveness of five infusions of characterized HLA-identical MSC in non immunosuppressed children with Osteogenesis Imperfecta (OI).
Timeline
- Start
- 2014-04
- Primary completion
- 2018-12
- Completion
- 2018-12
Publications
- Background Infante A, Gener B, Vazquez M, Olivares N, Arrieta A, Grau G, Llano I, Madero L, Bueno AM, Sagastizabal B, Gerovska D, Arauzo-Bravo MJ, Astigarraga I, Rodriguez CI. Reiterative infusions of MSCs improve pediatric osteogenesis imperfecta eliciting a pro-osteogenic paracrine response: TERCELOI clinical trial. Clin Transl Med. 2021 Jan;11(1):e265. doi: 10.1002/ctm2.265.
- Results Infante A, Cabodevilla L, Gener B, Rodriguez CI. Circulating TGF-beta Pathway in Osteogenesis Imperfecta Pediatric Patients Subjected to MSCs-Based Cell Therapy. Front Cell Dev Biol. 2022 Feb 9;10:830928. doi: 10.3389/fcell.2022.830928. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | — | — |