CD34+ Stem Cell Infusion to Augment Graft Function
Waning Donor Chimerism, Waning Immune Function, Primary Immunodeficiency Disease(s)
About this trial
This is an interventional treatment trial for Waning Donor Chimerism focused on measuring Primary Immunodeficiency Disease(s), Mixed Donor Chimerism, bone marrow failure syndromes, allogeneic hematopoietic stem cell transplant (HSCT), children
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
- Absence of an available original donor
- Failure to sign consent form, or inability to undergo informed consent process
- Pregnant or lactating female
- Uncontrolled GVHD
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Experimental
CD34+ selected stem cell infusion
An infusion of selected CD34+ stem cells will be given without any preparative regimen.