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

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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

NCT06731036•University of Florida

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients over 1 month of age
•The following category of patients is eligible for this protocol:
•a. Patients undergoing allogeneic transplantation for the following indications:
•i. Non-malignant disorders where graft versus host disease is detrimental:
•Severe combined immune deficiency
•Fanconi Anemia
•Dyskeratosis Congenita
•Sickle Cell Disease
•or
•b. Patients undergoing autologous transplantation intended for hematopoietic/immunologic reconstitution
+8 more criteria

Exclusion Criteria

•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
•Donor unable to donate peripheral blood stem cells
•Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire participation period and for at least 1 year after stem cell infusion.
•Females who are known to be pregnant or breastfeeding.
•Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Key Dates

Last Updated

February 18, 2026

Conditions

Severe Combined ImmunodeficiencyFanconi AnemiaDyskeratosis CongenitaSickle Cell Disease

Interventions

CD34+ cell enriched stem cell graft

BIOLOGICAL

Contacts

Giselle Moore-Higgs, PhD, APRN

CONTACT

(352) 273-9050 mooregj@ufl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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