Clinical Trial

Boost Brittle Bones Before Birth

Study acronym: BOOSTB4
Active, Not Recruiting Phase 1/2
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Summary
An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2018-10-10; most recent amendment 2025-09-06.
Status change: Recruiting → Active, Not Recruiting 2022-09-30
Status change: Not Yet Recruiting → Recruiting 2019-08-13
Trial Details
NCT Number NCT03706482
Lead Sponsor Karolinska Institutet
Collaborators: Karolinska University Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, University College, London, Universitätsklinikum Köln, UMC Utrecht, Leiden University Medical Center, Lund University
Conditions Osteogenesis Imperfecta
Enrollment 18 participants
Start Date 2019-08-12
Primary Completion 2030-04 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2025-09-12