NCT03706482

Boost Brittle Bones Before Birth

An Exploratory, Open Label, Multiple Dose, Multicentre Phase I/II Trial Evaluating Safety and Efficacy of Postnatal or Prenatal and Postnatal Intravenous 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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Osteogenesis Imperfecta

Interventions

Type	Name	Description
BIOLOGICAL	BOOST cells	Four doses of expanded human 1st trimester fetal liver-derived mesenchymal stem cells.

Timeline

• Start date: 2019-08-12
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2018-10-16
• Last updated: 2025-09-12

Locations

1 site across 1 country: Sweden