Stromal Therapy of Osteodysplasia After Allogeneic Bone Marrow Transplantation
Completed · Phase 1
Conditions studied: Osteodysplasia
In brief
Osteodysplasia or poorly formed bones, "brittle bones" is a genetic disease with no known proven treatments. Some forms of osteodysplasia may cause severe disability and even death. Eligible patients were limited to those children with Osteodysplasia who had undergone a previous allogeneic bone marrow transplant at St. Jude. The study intervention involved an infusion of a specified number of ex vivo expanded stromal cells obtained from the bone marrow of the same donor from whom they received their primary transplant procedure. These bone marrow stromal cells can become bone-forming cells, called osteoblasts. Participants then received 2 infusions of ex vivo expanded, gene marked cells not less than 6 months after bone marrow transplantation. The second cell infusion occurred between 14 to 21 days after the first infusion in the absence of toxicity. The goal of the study was to evaluate the safety and toxicity of these infusions.
Key facts
- Study ID
- NCT00186914
- Run by
- St. Jude Children's Research Hospital
- People needed
- 8
- Starts
- 1999-07-01
- Expected to finish
- 2008-01-01
- Last updated by the study team
- 2015-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with an appropriate genetic disorder who have had an allogeneic bone marrow transplant and currently maintain complete or mixed hematopoietic chimerism
- Patient must be < or equal to 18Kg
You may not qualify if…
- Presence of infection
- Presence of GVHD (graft versus host disease)or the need for prophylaxis
- Concurrent participation in any investigational study that could potentially confound the interpretation of the safety parameters being investigated in this study.
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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