Treatment Use of the CliniMACS® CD34 TCR Alpha/Beta for Allogenic Transplant (Expanded Access Use)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
AgeUp to 21
SponsorVictor Aquino
About this trial
The protocol is designed to provide access to patients to the Clinimacs® CD34 TCRαβ system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age less than 22 years of age
No available genotypically matched related donor (sibling)
Availability of a suitable donor and graft source
Haploidentical related mobilized peripheral blood cells
Disqualifiers
Pregnant or lactating females are ineligible as the risk to unborn children and infants is unknown
Presence of life-threatening, uncontrolled opportunistic infection (fungal, bacterial, or viral infections). Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation.
HIV or HTLV I/II infection
Trial design
Treatments tested in this trial
CliniMACS® CD34 TCR Alpha/Beta
DeviceCliniMACS System uses an automated antibody/magnetic beads column system that allows efficient depletion of TCRαβ and CD19+ cells without relevant loss of cell viability. Hematopoietic stem cells are retained in sufficient numbers to permit engraftment and hematopoietic reconstitution. Humanitarian Exemption IDE approval has been obtained for CD34+ cell selection as a method of T-cell depletion.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Victor Aquino
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
Source ClinicalTrials.gov