The present invention relates to methods and compositions for providing hematopoietic function in immunodeficient human patients, by selecting an expanded human umbilical cord blood stem/progenitor cell sample without taking into account the HLA-type of the expanded human cord blood stem/progenitor sample or the HLA-type of the patient; and administering the selected expanded human cord blood stem/progenitor cell sample to the patient. Methods for obtaining the expanded human cord blood stem/progenitor cell samples, banks of frozen expanded human cord blood stem/progenitor cell samples, and methods for producing such banks are also provided herein.

Compositions and methods for providing hematopoietic function without hla matching

The present invention relates to methods and compositions for providing hematopoietic function to human patients in need thereof, by selecting a pool of expanded human cord blood stem/progenitor cell samples for administration to the patient, wherein the samples in the pool collectively do not mismatch the patient at more than 2 of the HLA antigens or alleles typed in the patient; and administering the selected pool of expanded human cord blood stem/progenitor cell samples to the patient. Methods for obtaining the pools of expanded human cord blood stem/progenitor cell samples, banks of frozen pools of expanded human umbilical cord blood stem/progenitor cell samples, and methods for producing such banks are also provided herein.

Compositions and methods for providing hematopoietic function

Cell separation technologies play a vital role in the graft engineering of hematopoietic cellular fractions, particularly with the rapid expansion of the field of cellular therapeutics. The CliniMACS Plus Instrument (Miltenyi Biotec) utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells (HPCs), T cells, NK cells, and monocytes. These products are ultimately used for HPC transplantation and for the manufacture of adoptive immunotherapies. We evaluated the viable cell recovery and cell purity of selections and depletions performed on the CliniMACS Plus over a 10-year period at our facility, specifically assessing for the isolation of CD34+, CD4+, CD3+/CD56+, CD4+/CD8+, and CD25+ cells. Additionally, patient- and instrument-related factors affecting these parameters were examined. Viable cell recovery ranged from 32.3 ± 10.2% to 65.4 ± 15.4%, and was the highest for CD34+ selections. Cell purity ranged from 86.3 ± 7.2% to 99.0 ± 1.1%, and was the highest for CD4+ selections. Undesired cell fractions demonstrated a range of 1.2 ± 0.45 to 5.1 ± 0.4 log reductions. Red cell depletions averaged 2.12 ± 0.68 logs, while platelets were reduced by an average of 4.01 ± 1.57 logs. Donor characteristics did not impact viable cell recovery or cell purity for CD34+ or CD4+ cell enrichments; however, these were affected by manufacturing variables, including tubing size, bead quantity, and whether preselection platelet washes were performed. Our data demonstrate the efficient recovery of hematopoietic cellular fractions on the CliniMACS Plus that may be optimized by adjusting manufacturing variables.

Robust Selections of Various Hematopoietic Cell Fractions on the CliniMACS Plus Instrument.

BACKGROUND: Since the first umbilical cord blood (UCB) transplant, performed 25 years ago, UCB banks have been established worldwide for the collection and cryopreservation of UCB for autologous and allogeneic transplants. CONTENT: Much has been learned in a relatively short time on the properties of UCB hematopoietic progenitors and their clinical application. More interestingly, non-hematopoietic stem cells have been isolated from UCB. These cells can be grown and differentiated into various tissues including bone, cartilage, liver, pancreas, nerve, muscle and so on. The non-hematopoietic stem cells have an advantage over other sources of stem cells, such as embryonic stem cells or induced pluripotent stem cells, because their supply is unlimited, they can be used in autologous or allogeneic situations, they need minimal manipulation and they raise no ethical concerns. Future studies will test the potential of UCB cells for the treatment of several diseases including, among other possibilities, diabetes, arthritis, burns, neurological disorder and myocardial infarction. SUMMARY: In addition to hematopoietic stem cells, UCB contain a large number of non-hematopoietic stem cells. In the absence of ethical concern, the unlimited supply of UCB cells explains the increasing interest of using UCB for developing regenerative medicine. KEYWORDS: UCB, transplantation, UCB bank, HSC, MSC, CD34, CD133, VSEL

/pdf/application-of-umbilical-cord-blood-stem-cells-in-1y5e321sz5.pdf

Application of Umbilical Cord Blood Stem Cells in Regenerative Medicine

Allogeneic stem cell transplantation applications have improved tremendously over the past quarter of a century. The use of new immunosuppressive protocols and elimination of T cells by CD34+ cell enrichment or T cell depletion on apheresis products increases the chance of using partially matched or haploidentical grafts. This is without increasing the risk of graft-versus-host disease, which is observed as a major complication of hematopoietic stem cell transplantation. The aim of this protocol is to evaluate the results obtained from 6 different process cycles performed on 6 different days. We used the CliniMACS Plus system located in our Cell and Tissue Manufacturing Center Quality Control Unit which is already calibrated as a class D room and includes a class A microbiological safety cabinet inside. The average purity of the end products was 95.66%, excluding only one end product which was 70%; this was higher than the values in current studies in the field. Superior to the reported studies, the CD3 quantity in each end product was below the dedicated thresholds. BactecTM FX40 blood culture system test results were detected as negative for each end product. Endotoxin testing suggested the absence of endotoxin within the products. The consistent outcomes obtained from these 6 different process cycles confirmed that the CliniMACS® Plus process cycles performed in accordance with our well-defined quality management system procedure is sufficient for the routine application of high-quality and safe CD34+ enrichment processes within our clean room area.

A CD34+ Cell Enrichment Protocol of Hematopoietic Stem Cells in a Well-Established Quality Management System.

Improved immunomagnetic enrichment of CD34+ cells from umbilical cord blood using the CliniMACS cell separation system

Cryopreserved Ex-Vivo Expanded Murine Hematopoietic Progenitors Can Engraft Across MHC Barriers and Improve Survival In a Murine Model of Acute Radiation Syndrome.

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Improved immunomagnetic enrichment of CD34+ cells from umbilical cord blood using the CliniMACS cell separation system

Cryopreserved Ex-Vivo Expanded Murine Hematopoietic Progenitors Can Engraft Across MHC Barriers and Improve Survival In a Murine Model of Acute Radiation Syndrome.