Isolation and preservation of fetal hematopoietic and mesencymal system cells from non-controversial materials and/or tissues resulting from miscarriages and methods of therapeutic use
First Claim
1. A method for collection of human fetal tissue from second trimester miscarriages (16-20 weeks of gestation), comprising:
- (a) collection of human fetal bone marrow that contains hematopoietic stem or progenitor cells and stromal (mesencymal) cells;
(b) collection of other fetal tissues for therapies of life threatening diseases;
(c) cryopreservation of hematopoietic or progenitor cells, as well as other fetal tissues, utilizing a non-toxic cryopreservation cocktail consisting of 2% or less dimethyl sulfoxide, human serum albumin and dextran in RPMI medium; and
(d) thawing of the cryopreserved hematopoietic or progenitor cells, such that the stem or progenitor cells are at least 90% viable.
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Abstract
The present invention is directed to compositions of fetal hematopoietic stem and progenitor cells and stromal (mesencymal) cells derived from second trimester (16-20 weeks gestation) miscarriages, that are isolated, processed and cryopreserved, and the therapeutic uses of such stem and progenitor cells upon application. Such compositions may be useful for hematopoietic reconstitution and/or replacement in patients with various diseases and metabolic disorders. The invention also relates to methods for collecting, isolating, processing and cryopreserving of the fetal stem and progenitor cells of the invention. Importantly, the invention meets an urgent need in regenerative medicine while at the same time ensures utility of the product compositions because it utilizes fetal materials from second trimester (16-20 weeks of gestation) spontaneously lost pregnancies which are free of moral or ethical burdens.
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Citations
15 Claims
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1. A method for collection of human fetal tissue from second trimester miscarriages (16-20 weeks of gestation), comprising:
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(a) collection of human fetal bone marrow that contains hematopoietic stem or progenitor cells and stromal (mesencymal) cells; (b) collection of other fetal tissues for therapies of life threatening diseases; (c) cryopreservation of hematopoietic or progenitor cells, as well as other fetal tissues, utilizing a non-toxic cryopreservation cocktail consisting of 2% or less dimethyl sulfoxide, human serum albumin and dextran in RPMI medium; and (d) thawing of the cryopreserved hematopoietic or progenitor cells, such that the stem or progenitor cells are at least 90% viable. - View Dependent Claims (2, 3, 6, 7, 8, 9, 10)
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4. (canceled)
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5. A method for hematopoietic or immune reconstitution of a human comprising:
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(a) isolating human fetal bone marrow stem cells from 16-20 weeks miscarriages; and (b) introducing the fetal bone marrow cells into suitable human host, such that the fetal stem cells are viable and can proliferate within the host.
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11. A method for hematopoietic or immune reconstitution of a human comprising:
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(a) isolating human fetal components from 16-20 week miscarriages, containing hematopoietic stem and progenitor cells; (b) cryopreserving the hematopoietic components, utilizing a non-toxic cryopreservation cocktail consisting of 2% or less dimethyl sulfoxide, human serum albumin and dextran in RPMI medium; (c) thawing the hematopoietic components; and (d) introducing the fetal cells into a suitable human host, such that the hematopoietic stem and progenitor cells are viable and can proliferate and reconstitute within the host. - View Dependent Claims (12, 13, 14)
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15. A method for hematopoietic or immune reconstitution of a human comprising introducing into the human a composition comprising human fetal hematopoietic stem cells derived from fetal components from 16-20 week miscarriages, in which the stem cells are progeny of cells which have been previously cryopreserved , utilizing a non-toxic cryopreservation cocktail consisting of 2% or less dimethyl sulfoxide, human serum albumin and dextran in RPMI medium.
Specification