NCT06731036

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: —

Summary

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.

Conditions

• Severe Combined Immunodeficiency
• Fanconi Anemia
• Dyskeratosis Congenita
• Sickle Cell Disease

Interventions

Type	Name	Description
BIOLOGICAL	CD34+ cell enriched stem cell graft	Patients will receive a peripheral blood stem cell graft that has been CD34+ cell enriched using the Miltenyi CliniMACS Prodigy® system.

Timeline

• First posted: 2024-12-12
• Last updated: 2026-02-18