A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorChristopher Dvorak
About this trial
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.
Eligibility criteria
Qualifiers
Male or female 0-30 years of age at time of transplant admission
Documentation of a disease requiring HCT
A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Disqualifiers
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
Patient with an anticipated life expectancy of <1 month
Trial design
Treatments tested in this trial
- CliniMacs®
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Christopher Dvorak
Lead sponsor
University of California, San Francisco
Sponsor institution
Source ClinicalTrials.gov