|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 March 2015 |
|
Main ID: |
NCT00187018 |
|
Date of registration:
|
12/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot Study
|
|
Scientific title:
|
Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot Study |
|
Date of first enrolment:
|
March 2004 |
|
Target sample size:
|
9 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00187018 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Gregory Hale, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St. Jude Children's Research Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Must have been previously enrolled on TOIT protocol at St. Jude Children's Research
Hospital
- Must have original bone marrow donor available and willing to participate as a donor
- Normal liver function
- Hemoglobin >10gm/dl
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteogenesis Imperfecta
|
|
Intervention(s)
|
|
Biological: Bone marrow transplant
|
|
Primary Outcome(s)
|
|
To find out if there is any effect on the growth rate of children with osteogenesis imperfecta who receive donor bone marrow which has had CD3+ cells removed
|
|
To find out the effects (good and bad) of bone marrow cell infusions using donor bone marrow that has had CD3+ cells removed
|
|
To find out if there is any effect on the total bone mineral content of children with OI
|
|
who receive donor bone marrow which has had CD3+ cells removed
|
|
Secondary Outcome(s)
|
|
To find out the effect of the CD3 washed-out marrow cell therapy on the growth rate of the children
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|