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Boost Brittle Bones Before Birth

NCT03706482 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-09-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

BOOST cells

Four doses of expanded human 1st trimester fetal liver-derived mesenchymal stem cells.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Universitätsklinikum Köln

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Lund University

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Eva Åström, MD PhD · Karolinska University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2030-04-30
Completion
2030-04-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03706482 on ClinicalTrials.gov