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Plasma-depleted, non-red blood cell-depleted umbilical cord blood compositions and methods of use

A composition and technology of red blood cells, which can be applied in the fields of application, preservation of human or animal bodies, and medical raw materials derived from mammals, can solve the problems of cord blood stem cell supply shortage, high cost, and insufficient number of cells, etc., and achieve overall survival rate The effect of increasing, reducing the incidence rate, and reducing the mortality rate

Active Publication Date: 2008-08-27
STEMCYTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Second, obtaining these cells from embryonic or fetal tissue, including aborted fetuses, raises ethical issues
However, cord blood stem cells are in extremely short supply because of collection limitations, insufficient numbers of cells collected from cord blood (especially if used to treat adult patients) and the high cost of building large banks

Method used

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  • Plasma-depleted, non-red blood cell-depleted umbilical cord blood compositions and methods of use
  • Plasma-depleted, non-red blood cell-depleted umbilical cord blood compositions and methods of use
  • Plasma-depleted, non-red blood cell-depleted umbilical cord blood compositions and methods of use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131] Example 1. Exemplary Plasma Depletion Umbilical Cord Blood Unit

[0132] The present embodiment provides an exemplary cord blood (UCB) composition substantially depleted of plasma but not red blood cells.

[0133] Standard cryoprotectant volume: about 60ml plasma depletion unit uses about 15ml cryoprotectant.

[0134] If CV=volume of cord blood collected, AV=volume of anticoagulant (for example, between about 23-about 35ml), PV=volume of plasma-depleted cord blood, PAV=volume of anticoagulant after processing, and APV=anticoagulant To remove the volume of umbilical cord blood from coagulant plasma, an exemplary UCB composition of the present invention contains:

[0135] PV=60ml×(CV / (CV+AV));

[0136] PAV=60ml×(AV / (CV+AV));

[0137] PV+PAV=APV=60ml; and

[0138] Volume before freezing = APV + cryoprotectant volume = 60 ml + 15 ml = 75 ml.

Embodiment 2

[0139] Example 2. Removal of umbilical cord blood unit plasma increases hematocrit and red blood cell concentration

[0140] This example illustrates that processing and collecting umbilical cord blood (UCB) according to the method of the present invention increases the hematocrit (ie, the percentage of red blood cells in the final volume) and red blood cell (RBC) concentration of UCB units.

[0141] The UCB collected from 488 newborns was first tested to determine the hematocrit ("PRE-HCT%") and RBC concentration ("PRE-RBC(10 6 / μl)”), and then the plasma removal process described herein. After processing, the hematocrit ("POST-HCT%") and RBC concentration ("POST-RBC(10 6 / μl)”) and white blood cell concentration (“POST-WBC(10 3 / μl)”). As shown in Table 3, processing UCB units by plasmapheresis according to the methods described herein can substantially increase hematocrit and RBC concentration.

[0142] Table 3. 488 cord blood units before and after processing

[0143] ...

Embodiment 3

[0145] Example 3. Comparison of plasma-depleted, red blood cell-depleted, and whole blood cord blood units

[0146] This example compares the plasma-depleted cord blood composition of the present invention with whole blood and HES red blood cell depletion units.

[0147] Hematocrit:

[0148] The average hematocrit of plasma depleted (PD) cord blood (UCB) units is about 1.8 times that of whole blood units or red blood cell depleted (RD) units. In terms of volume, the hematocrit of a given unit corresponds to the percentage of red blood cells (RBC). Without intending to be limited to any specific theory, the PD UCB unit of the present invention has a higher hematocrit, which is beneficial to provide better cryoprotective properties and / or improved clinical effects.

[0149] Hematocrit

Whole blood

PD blood

RD blood

≤40％

≥50％

≤50％

[0150] Red blood cell concentration:

[0151] The average RBC concentration of PD units is about 1.8 tim...

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Abstract

The umbilical cord blood (UCB) compositions of the present invention possess the unique features of having plasma that is substantially depleted from the UCB unit and red blood cells (RBC) that are not depleted from the UCB unit. Such UCB units can be prepared by a process that combines plasma depletion with cryopreservation, selection, thawing, and / or transplantation of hematopoietic stem cells to provide superior clinical outcome by maximizing post-processing cell recovery and post-thaw infusion cell dose. Methods for treating a wide variety of malignant diseases and benign diseases associated with the hematopoietic system by administering the UCB compositions of the present invention are also provided.

Description

[0001] Cross references to related applications [0002] This application relates to U.S. Provisional Application No. 60 / 687,127 filed on June 2, 2005 and 60 / 733,956 filed on December 3, 2005. The contents of these two applications are incorporated herein by reference in their entirety for all purposes. Background of the invention [0003] The identification, isolation and preparation of human stem cells have aroused great interest. Human stem cells are totipotent or pluripotent precursor cells that can self-renew and produce various mature human cell lineages. This ability is the basis for cell differentiation and specialization required for organ and tissue development. In recent years, the success of stem cell transplantation has provided new clinical tools for bone marrow reconstitution and / or supplementation after myeloablation caused by diseases, exposure to toxic compounds and / or radiation. There is other evidence that it can be used to regenerate many (if not all) tissues a...

Claims

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Application Information

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IPC IPC(8): A01N1/02A61K35/51
Inventor R·乔
Owner STEMCYTE
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