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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 - KIBB01

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Trial Profile

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 - KIBB01

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Nov 2025

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At a glance

  • Drugs BT 101-BOOST Pharma (Primary)
  • Indications Osteogenesis imperfecta
  • Focus Adverse reactions; Pharmacodynamics
  • Acronyms BOOSTB4

Most Recent Events

  • 26 Nov 2025 New trial record
  • 10 Nov 2025 According to the BOOST Pharma media release, the BOOSTB4 trial has completed its final dosing. All doses of mesenchymal stem cells (MSCs) have been successfully administered to the participating children with Osteogenesis Imperfecta (OI).
  • 31 Oct 2025 According to BOOST Pharma media release, two-year follow-up data from the landmark BOOSTB4 study has been selected for presentation by BOOST Pharma co-founder Dr. Cecilia Gotherstrom at the prestigious 15th International Conference on Osteogenesis Imperfecta (OI), taking place from October 29-31, 2025, in Hong Kong.

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