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Boost Brittle Bones Before Birth | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT03706482•Karolinska Institutet

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Parent's/legal guardian's signed informed-consent form
•2. Clinical diagnosis of OI type III or severe type IV AND
•3. Molecular diagnosis of OI (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
•4. Age less than 18 months (calculated from gestational week 40+0, i.e. the corrected age)
•5. Parent/legal guardian over 18 years of age
•1. Woman has signed the informed-consent form
•2. Only women where termination of the pregnancy is no longer possible or where the women are committed to continue the pregnancy may be included in the trial
•3. Suspicion of OI type III or severe type IV in the fetus on ultrasound findings AND
•4. Molecular diagnosis of OI in the fetus (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
•5. Gestation age between 16+0 and 35+6 weeks+days
+5 more criteria

Exclusion Criteria

•1. Existence of other known disorder that might interfere with the treatment, such as, but not limited to organ dysfunction (for example liver or renal failure or bronchopulmonary dysplasia), congenital heart defect, hypoxic encephalopathy l-lll, severe neurological problems, immune deficiencies, muscle diseases, severe malformations or syndromes diagnosed by clinical examination.
•2. Any contraindication for invasive procedures such as a moderate/severe bleeding tendency
•3. Known risk factors for clotting, such as, but not limited to previous blood clot, family history of clots, clotting disorder (inherited or acquired), heart failure, inflammatory disorders (for example lupus, rheumatoid arthritis, inflammatory bowel disease)
•4. Positive Donor Specific Antibody-test
•5. Known allergy/hypersensitivity to Fungizone and/or Gensumycin
•6. Abnormal karyotype or other confirmed genetic syndromes
•7. Oncologic disease (previous or current malignancy)
•8. Inability to comply with the trial protocol and follow-up schedule
•9. Inability to understand the information and to provide informed consent
•1. Multiple pregnancy
+12 more criteria

Locations (1)

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Key Dates

Start Date

August 12, 2019

Primary Completion Date

April 1, 2030

Completion Date

April 1, 2030

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Osteogenesis Imperfecta

Interventions

BOOST cells

BIOLOGICAL

Effects of Bisphosphonates on OI-Related Hearing Loss

NCT04152551

Osteogenesis Imperfecta

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ACTIVE_NOT_RECRUITING

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

NCT05317637

Osteogenesis Imperfecta

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COMPLETED

Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

NCT00001594

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Boost Brittle Bones Before Birth

Inclusion Criteria

Exclusion Criteria

Effects of Bisphosphonates on OI-Related Hearing Loss

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid

Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)