CD34+ Stem Cell Infusion to Augment Graft Function
Stopped early · Phase 2
Conditions studied: Waning Donor Chimerism, Waning Immune Function, Primary Immunodeficiency Disease(s), Bone Marrow Failure
In brief
The purpose of this study is to determine if infusing additional special donor cells will help to improve graft or immune function in previously transplanted children with immune deficiencies and bone marrow failures.
Key facts
- Study ID
- NCT01856582
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 23
- Starts
- 2010-10-01
- Expected to finish
- 2018-08-15
- Last updated by the study team
- 2019-11-22
Who can join
Age: any, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible for this protocol, patients must have the following:
- Primary immunodeficiency (e.g. SCID, Wiskott-Aldrich and/or other more rare conditions and other bone marrow failure syndromes) with prior allogeneic stem cell transplant.
- Waning donor chimerism or immune function that is inadequate to correct their disease or clinical condition, for which primary transplant was given, as determined by their attending physician.
- Available primary donor.
- Must not have other organ dysfunction deemed by the attending physician to preclude this procedure.
- Age < 35 years at time of transplant
- One of the following must be true:
- Patients must have evidence of persistent or recurrent immunodeficiency or thrombocytopenia.
- OR-
- Primary immunodeficiency disease with known potential to progress to malignant condition if untreated.
- OR-
- Debilitating secondary disease known to be a consequence of inadequate immune response to known agent or pathogen, uncontrollable by other available medical therapies (e.g. third patient described on page 5).
You may not qualify if…
- Absence of an available original donor
- Failure to sign consent form, or inability to undergo informed consent process
- Pregnant or lactating female
- Uncontrolled GVHD
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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