Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age1+
SponsorChildren's Hospital of Philadelphia
About this trial
The primary objective of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed, informed consent
Participants of childbearing potential must have a negative pregnancy test as per institutional SOP
Patients who do not meet criteria for current open, institutional protocols using CliniMACs device for β T/CD19+ depletion
Non-malignant diseases
Disqualifiers
Suitable and available HLA matched sibling donor. However, patients with fully matched related donors (including siblings) may be eligible in special circumstances where use of an unmanipulated bone marrow graft has increased risks for donor or recipient.
Donor unable to donate peripheral stem cells
Pregnant participants
Donor selection will comply with 21 CFR 1271*
Trial design
Treatments tested in this trial
Apha/beta T and CD19+ cell depletion using CliniMACS device
DeviceStem cells will be processed using the CliniMACS device for alpha/beta and CD19+ T cell depletion. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
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Source ClinicalTrials.gov