Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta

Completed · Phase 1

Conditions studied: Osteogenesis Imperfecta Type II, Osteogenesis Imperfecta Type III

In brief

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.

Key facts

Study ID

NCT01061099

Run by

Nationwide Children's Hospital

People needed

5

Starts

2010-02-01

Expected to finish

2014-02-01

Last updated by the study team

2015-04-24

Who can join

Age: any, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Dependent on supplemental oxygen
• Concurrent Infection

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.