# US 2013/0280207 A1 · Compositions and methods for reducing the risk of spontaneous abortion in a human female > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0280207 A1 - Document ID: US20130280207A1 - Status: Published application - Kind: A1 - Application number: 13/924,823 - Filed: 2013-06-24 - Published: 2013-10-24 - Earliest claimed: 2003-10-24 - Assignees: Nora Therapeutics, Inc. - Applicants: Nora Therapeutics, Inc. - Inventors: Darryl L. Carter - Web page: https://patentgrep.com/patent/US20130280207A1 ## CPC - A61K 38/193: {Colony stimulating factors [CSF]} - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3 - A61K 38/1816: {Erythropoietin [EPO]} - A61K 38/1841: {Transforming growth factor [TGF]} - A61K 38/20: Interleukins [IL] - A61K 38/21: Interferons {[IFN]} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 9/12: Antihypertensives - A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives - A61P 15/06: Antiabortive agents; Labour repressants - G01N 33/689: {related to pregnancy or the gonads} - G01N 33/6893: {related to diseases not provided for elsewhere} - G01N 2800/368: Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Methods and kits for preventing or reducing the likelihood of implantation failure or miscarriage in a recipient of artificial insemination are provided. The methods include administering into a recipient of artificial insemination in need of such treatment an effective amount of granulocyte colony stimulating factor (G-CSF). ## Claims ### Claim 1 A method for reducing the risk of spontaneous abortion, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of a spontaneous abortion, wherein the G-CSF has an increased half-life and is administered at a dose ranging from about 1 μg/kg/day to about 100 μg/kg/day during the first 20 weeks of pregnancy. ### Claim 2 A method for reducing the risk of preterm labor, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of preterm labor, wherein the G-CSF has an increased half-life and is administered at a dose ranging from about 1 μg/kg/day to about 100 μg/kg/day for a plurality of days. ### Claim 3 A method for reducing the risk of preeclampsia, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of preeclampsia, wherein the G-CSF has an increased half-life and is administered at a dose ranging from about 1 μg/kg/day to about 100 μg/kg/day. ### Claim 4 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life is administered parenterally, enterally, subcutaneously, percutaneously, transdermally, intradermally, intravenously, topically, by inhalation, or by implantation. ### Claim 5 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life is administered subcutaneously. ### Claim 6 (depends on 1) The method according to claim 1, wherein the human female was a recipient of an assisted reproduction procedure. ### Claim 7 (depends on 4) The method according to claim 4, wherein the assisted reproduction procedure is in vitro fertilization, artificial insemination, or gamete intrafallopian tube transfer. ### Claim 8 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life is administered at a dose ranging from 1 μg/kg/day to 20 μg/kg/day. ### Claim 9 (depends on 1) The method according to claim 1, wherein the dose is administered daily or is administered daily through the 20th week of pregnancy. ### Claim 10 (depends on 1) The method according to claim 1, wherein the dose is administered for one day, two days, three days, four days, one week, two weeks, three weeks, or four weeks. ### Claim 11 (depends on 1) The method according to claim 1, wherein the dose is administered daily for four weeks, three weeks, two weeks, or one week during the first trimester of pregnancy. ### Claim 12 (depends on 1) The method according to claim 1, wherein the dose is administered daily for four weeks, three weeks, two weeks, or one week during the second trimester of pregnancy ### Claim 13 (depends on 1) The method according to claim 1, wherein the dose is administered for at least five consecutive days during the first or second trimester of pregnancy. ### Claim 14 (depends on 1) The method according to claim 1, wherein the dose is administered for at least five consecutive days during the first or second week of pregnancy. ### Claim 15 (depends on 1) The method according to claim 1, wherein the dose is administered through the second trimester of pregnancy. ### Claim 16 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life is administered with another active agent. ### Claim 17 (depends on 16) The method according to claim 16, wherein the other active agent is an immunosuppressive agent, an anti-inflammatory agent, vitamin D, aspirin, heparin, intravenous immunoglobulin (IVIG), or progesterone. ### Claim 18 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life is formulated as a composition comprising a pharmaceutically acceptable carrier or diluent. ### Claim 19 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life comprises filgrastim, nartograstim, or lenograstim. ### Claim 20 (depends on 1) The method according to claim 1, wherein the G-CSF having an increased half-life comprises a G-CSF fusion protein, a G-CSF hybrid, or a G-CSF conjugated to a water soluble polymer. ### Claim 21 (depends on 20) The method according to claim 20, wherein the G-CSF having an increased half-life is a G-CSF conjugated to a water soluble polymer, wherein the water soluble polymer comprises one or more polyethylene glycol molecules. ### Claim 22 (depends on 20) The method according to claim 20, wherein the G-CSF having an increased half-life is a G-CSF conjugated to a water soluble polymer, wherein the G-CSF comprises filgrastim, nartograstim, or lenograstim. ### Claim 23 (depends on 20) The method according to claim 20, wherein the G-CSF conjugated to a water soluble polymer is pegfilgrastim. ### Claim 24 (depends on 1) The method according to claim 1, wherein the human female is in the first trimester of pregnancy, or is in the first or second month of pregnancy. ### Claim 25 (depends on 1) The method according to claim 1, wherein the human female previously had one or more spontaneous abortions, two or more spontaneous abortions, or recurrent spontaneous abortions.