About this trial
Allogeneic stem cell transplantation (alloSCT) is utilized for various underlying diseases. AlloSCT is limited by graft versus host disease (GVHD), graft rejection, viral infections, and post-transplant lymphoproliferative disorders. To mitigate graft versus host disease, graft manipulation has been taking place with CD34+ selection to decrease T-cells entering into the patient, thus lowering the risk of GVHD.
Historically CD34+ manipulation has been performed under a humanitarian use device by utilizing the Miltenyi CliniMACs CD34 Reagent System. This was used for patients with AML in first remission. This approach has additionally been used for patients with sickle cell disease, immune deficiencies, and poor graft function with excellent efficiency. The purpose of this protocol is to create expanded access of CD34+ manipulation for various underlying diseases utilizing the Miltenyi CliniMACS Prodigy® device.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 1 month of age
Severe combined immune deficiency
Fanconi Anemia
Dyskeratosis Congenita
Disqualifiers
Patients with a fully HLA matched sibling donor
Patients with active graft versus host disease
Patient with uncontrollable transplant associated thrombotic microangiopathy
Patient not cleared by transplant provider to process
Trial design
Treatments tested in this trial
CD34+ cell enriched stem cell graft
Biological/VaccinePatients will receive a peripheral blood stem cell graft that has been CD34+ cell enriched using the Miltenyi CliniMACS Prodigy® system.
Treatment groups
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
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