Human pluripotent hematopoietic colony stimulating factor,...

Drug – bio-affecting and body treating compositions – Lymphokine

Reexamination Certificate

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C514S002600, C530S350000, C530S351000

Reexamination Certificate

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06419918

ABSTRACT:

This application concerns human pluripotent colony stimulating factor (P-CSF) also known as pluripoietin.
BACKGROUND
This work was done in part with government funding under United States Public Health Service Grants CA-32516, HL-31780, CA-20194, CA-23766 and CA-00966. Therefore, the government has certain rights in this invention.
Abbreviations
CFU-GEMM: Colony forming unit - granulocyte, erythroid, macrophage, megakaryocyte.
CFU-GM: Colony forming unit - granulocyte-macrophage
BFU-E: erythroid burst forming unit
GM-CSF: Granulocyte-macrophage colony stimulating factor
Colony-stimulating factors (CSFs) are hormone-like glycoproteins produced by a variety of tissues and tumor cell lines which regulate hematopoiesis and are required for the clonal growth and maturation of normal bone marrow cell precursors in vitro (Burgess, A. W., et al. (1980) Blood
56
:947-958; Nicola, N. A., et al. (1984) Immunology Today
5
:76-81). In contrast to the murine system (Nicola, N. A., et al. (1983) J. Biol. Chem.
258
:9017-9021; Ihle, J. N., et al. (1982) J. Immunol.
129
:2431-2436; Fung, M. C., et al. (1984) Nature
307
:233-237; Gough, N. M., et al. (1984) Nature
309
:763-767), human CSFs have been less well characterized, both biologically and biochemically (Nicola, N. A., et al. (1979) Blood
54
:614-627; Wu, M. C., et al. (1980) J. Clin. Invest.
65
:772-775; Golde, D. W., et al. (1980) Proc. Nat'l. acad. Sci. USA
77
:593-596; Lusis, A. J., et al. (1981) Blood 57:13-21; Abboud, C. N., et al. (1981) Blood
58
:1148-1154; Okabe, T., et al. (1982) J. Cell. Phys.
110
:43-49). Purification to apparent homogeneity has only been reported for macrophage active CSF (CSF-1) (Das, S. K., et al. (1981) Blood
58
:630-641; Das, S. K., et al. (1982) J. Biol. Chem.
257
:13679-13684) and erythroid potentiating activity [Westbrook, C. A. et al. J. Biol. Chem.
259
:9992-9996 (1984)] and for granulocyte-macrophage CSF (GM-CSF) [Gasson, J. C., et al. Science
226
:1339-1342 (1984)], but not for human pluripotent CSF.
Assays are available to detect human clonogenic precursors that give rise to cells of the erythroid, granulocytic, megakaryocytic, macrophage (CFU-GEMM) (Fauser, A. A., et al. 1978) Blood
52
:1243-1248; Fauser, A. A., et al. (1979) Blood
53
:1023-1027) and possibly lymphoid (Messner, E. A., et al. (1981) Blood
58
:402-405) lineages. CSFs with activities on these multipotential progenitor cells (pluripotent CSF or P-CSF) are produced by mitogen- or antigen activated T lymphocytes (Ruppert, S., et al. (1983) Exp. Hematol.
11
:154-161) and constitutively by human tumor cell lines such as the SK-HEP-1 human hepatoma cell lines (J. Gabrilove, K. Welte, Li Lu, H. Castro-Malaspina, M. A. S. Moore, Blood,
in Press
and hereby incorporated by reference); the 5637 bladder carcinoma cell lines (reported herein and in Proc. Nat'l. Acad. Sci.
82
:1526-1530 1985 hereby incorporated by reference); and by the HTLV-transformed lymphoid cells (Fauser, A. A., et al. (1981) Stem Cells
1
:73-80;Salahuddin S. Z., et al. (1984) Science
223
:703-707). Pluripotent CSF is involved in the proliferation and differentiation of pluripotent progenitor cells leading to the production of all major blood cell types. This is therefore a broad spectrum CSF. It also induces differentiation of leukemic cells.
SUMMARY
This application concerns human puripotent colony stimulating factor CSF for the stimulation of proliferation and differentiation of pluripotent progenitor cells to all major blood cell types which is purified to apparent homogeneity. Its biological effects include the induction of functional markers of differentiation of normal and leukemic cells.


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