CompletedPhase 1

Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta

United States5 participantsStarted 2010-02

Plain-language summary

This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI). Participants will receive MSC infusions approximately every 4 months to complete a total of 6 infusions over 20 months. Participants will be followed for 4 months post their last MSC infusion.

Who can participate

Age range19 Years

SexALL

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Inclusion Criteria: * Subjects less than or equal to 19 years of age at the time of enrollment * Children with a diagnosis of severe of Type II or III osteogenesis imperfecta * Parent or sibling greater than or equal to 18 years of age, donor willing to or has already undergone HLA typing, and willing and able to provide bone marrow * BMT greater than 5 years ago for Stratum A Exclusion Criteria: * Dependent on supplemental oxygen * Concurrent Infection

What they're measuring

To determine the safety or repeated infusions of donor-derived and MSCs in subjects with severe osteogenesis imperfecta > 5years after an allogeneic bone marrow transplant and no prior bone marrow transplant.

Timeframe: Completion of study

Trial details

NCT IDNCT01061099

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Osteogenesis Imperfecta Type II trials