Expanded Access to CD34+ Selection Utilizing Miltenyi CliniMACS Prodigy® for Patients Receiving Peripheral Blood Stem Cell Transplantations and Stem Cell Boosts

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age1+
SponsorUniversity of Florida

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

Qualifiers

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

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators