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Boost Brittle Bones Before Birth

Study acronym: BOOSTB4
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revisedv10
  2. Re-verified, no change to tracked fieldsv9
  3. Eligibility criteria expanded, about 46 wordsv8
  4. Primary and study completion dates: Dec 30, 2031 to Apr 2030
    • Eligibility criteria expanded, about 6 words
    v7
  5. Primary completion date: Aug 12, 2023 to Dec 30, 2031v6 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 18
    • Study completion date: Aug 12, 2033 to Dec 30, 2031
    • Site details revised
Show 4 earlier versionsHide 4 earlier versions
  1. Lead sponsor: Cecilia Götherström to Karolinska Institutet
    • Enrollment target: 210 to 30
    • Eligibility criteria revised
    v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jan 1, 2023 to Aug 12, 2023
    • Start date changed from estimate of May 1, 2019 to Aug 12, 2019
    • Study sites: 0 to 1
    • Study completion date: Jan 1, 2033 to Aug 12, 2033
  3. Start date: Jan 1, 2019 to May 1, 2019v3
  4. Collaborators expanded, about 25 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Osteogenesis Imperfecta
Related terms Osteogenesis Imperfecta
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov