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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 May 2015 |
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Main ID: |
NCT01061099 |
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Date of registration:
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01/02/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta
STOD3 |
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Scientific title:
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A Pilot Study to Assess the Safety and Feasibility of Repeated Infusions of Mesenchymal Stromal Cells (MSC) in Children With Osteogenesis Imperfecta |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01061099 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Alix Seif, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
19 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteogenesis Imperfecta Type III
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Osteogenesis Imperfecta Type II
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Intervention(s)
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Biological: Mesenchymal Stromal Cells
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Primary Outcome(s)
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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.
[Time Frame: Completion of study]
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Secondary Outcome(s)
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To determine the change in clinical course (growth, bone mineral content, fracture rate, development/activities) of subjects after experimental MSC intervention therapy as compared with each subject's own pre-MSC intervention therapy.
[Time Frame: Completion of Study]
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To determine if MSCs elicit an immune response after repeated infusions.
[Time Frame: Completion of study]
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Secondary ID(s)
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2008-4-5947
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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