Status:
TERMINATED
CD34+ Stem Cell Infusion to Augment Graft Function
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Hoxworth Blood Center
Conditions:
Waning Donor Chimerism
Waning Immune Function
Eligibility:
All Genders
Up to 35 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
The purpose of this study is to investigate the usefulness of infusing purified CD34+ cells of donor origin in order to augment graft function in response to declining chimerism after initially perfor...
Eligibility Criteria
Inclusion
- 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
- Absence of an available original donor
- Failure to sign consent form, or inability to undergo informed consent process
- Pregnant or lactating female
- Uncontrolled GVHD
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01856582
Start Date
October 1 2010
End Date
August 15 2018
Last Update
November 22 2019
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229