Methods for stem cell transplantation
a stem cell and transplantation technology, applied in the field of stem cell transplantation, can solve the problems of graft versus host disease (gvhd), high risk of graft rejection, inappropriate time-consuming registration searches in some high-risk patients, etc., and achieve the effect of increasing the number of t cells and minimizing harmful effects
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example 1
Depletion
[0061]Methods for αβ T cell depletion are known in the art and any method known in the art may be used. In one embodiment, the following method of αβ T cell depletion is used. The CLINIMACS® device with the α / β TCR Reagent Kit and other associated reagents is used for αβ T cell depletion. CLINIMACS®α / β TCR Reagent is a sterile monoclonal antibody reagent specific for αβ cells. The depletion of the αβ T-cells will be performed according to the manufacturer's instructions and as previously described (16). In brief, the leukapheresis / ex-vivo expanded product are incubated with the appropriate antibodies that are conjugated to magnetic particles and then are processed using the CLINIMACS® device (Miltenyi Biotec). CLINIMACS® plus Instrument is a software-controlled instrument that processes the blood sample (cell product). The CLINIMACS® Tubing Set is a single-use, sterile, disposable tubing set with proprietary cell selection columns. The CLINIMACS® PBS / EDTA Buffer is a steril...
example 2
δ T Cell Expansion
[0062]Methods for γδ T cell expansion are known in the art and any method known in the art may be used. In one embodiment, peripheral blood mononuclear cells (PBMC) are obtained via a peripheral blood draw or leukapheresis. The PBMC product is placed into culture at a density of 1-2×106 / mL with addition of 2 mM ZOMETA® (Novartis, Inc.; zoledronic acid) and 100 u / mL Interleuken-2 (IL-2 Miltenyi Biotec, Bergish Gladbach, GERMANY) and appropriate GMP-grade base media culture or bioreactor system that allows monocytes to adhere (e.g. tissue culture plastic or the PRODIGY® bioreactor system (Miltenyi Biotech). Following 14 days of culture the cells are harvested and depleted of αβ T cells.
[0063]Preferably, the following method of αβ T cell depletion is used. The PRODIGY® OR CLINIMACS® device with the α / β TCR Reagent Kit and other associated reagents is used for αβ T cell depletion. CLINIMACS®α / β TCR Reagent is a sterile monoclonal antibody reagent specific for αβ cells....
example 3
Study
[0064]To be enrolled in the study, patients must fulfill all eligibility criteria and not be excluded by an exclusion criteria.
Eligibility Criteria
[0065]Eligibility criteria for the study are as follows:
(i) Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows; (a) Acute lymphoblastic leukemia [ALL]25 with high-risk features or relapsed disease; (b) Hodgkin26 or Non-Hodgkin lymphoma27 [HL or NHL]: relapsed disease where remission duration is less than 1 year, relapse after previous autologous transplant, or failure to achieve CR with chemotherapy; and (c) Myeloid malignancy (acute myeloid leukemia [AML]28 with intermediate / high-risk features (per NCCN criteria) or relapsed disease, OR chronic myeloid leukemia [CML]29 in hematological remission or chronic phase).28;
(ii) myeloid disorder (myelodysplastic syndrome [MDS]30 with intermediate / high ...
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