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Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)

Transplant-Related Disorder Clinical Trial

Official title:
Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta to Prepare Cells for an Unlabeled Indication Using an HLA-Compatible Related or Unrelated Donor for Allogenic Transplant

Clinical Trial Summary

The purpose of this IDE protocol is to provide access to TCR Alpha/Beta+/CD19+ depleted allogeneic hematopoietic stem cell (HSC) in patients who require hematopoietic stem cell transplantation.

Clinical Trial Description

Allogeneic hematopoietic stem cell transplant (HSCT) is the only known curative therapy for a variety of non-malignant and malignant disorders1-4. Only about 25% of patients have an HLA-matched sibling and in about 16-75% (depending on ethnicity), a 10/10 HLA-matched unrelated donor can be identified. The use of mis-matched or haploidentical donors is associated with a higher risk of post-transplant mortality due to the development of severe graft versus host disease, graft failure and the development of infection due to the use of immunosuppression or T cell depletion. The protocol is designed to provide access to patients to the Clinimacs® CD34 TCR Alpha/Beta system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06393660
Study type Expanded Access
Source University of Texas Southwestern Medical Center
Contact
Status Temporarily not available
Phase
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