TREATMENT OF INFLAMMATORY DISEASES USING PLACENTAL STEM CELLS
Provided herein are methods of treatment of individuals having an immune-related disease, disorder or condition, for example, inflammatory bowel disease, graft-versus-host disease, multiple sclerosis, rheumatoid arthritis, psoriasis, lupus erythematosus, diabetes, mycosis fungoides (Alibert-Bazin syndrome), or scleroderma using placental stem cells or umbilical cord stem cells.
1 .- 18 . (canceled)
19 . A method of treating an individual having graft-versus-host disease, comprising administering to the individual a therapeutically effective amount of non-hematopoietic placental stem cells, wherein said placental stem cells are CD10+, CD34−, CD105+, CD200+, and CD117−, as detectable by flow cytometry, and wherein the therapeutically effective amount is an amount sufficient to cause a detectable improvement in one or more symptoms of said graft-versus-host disease.
20 . The method of claim 19 , wherein said graft-versus-host disease is acute graft-versus-host disease.
21 . The method of claim 19 , wherein said graft-versus-host disease is chronic graft-versus-host disease.
22 . The method of claim 19 , wherein said graft-versus-host disease developed in said individual after an allogeneic bone marrow transplant, after a solid organ transplant, or after a composite tissue allograft.
23 . The method of claim 20 , wherein said symptom of acute graft-versus-host disease is one or more of dermatitis, pruritic skin, rash, enteritis, hepatitis, fever, erythroderma, desquamation, a raised level of alanine aminotransferase, a raised level of aspartate aminotransferase, a raised level of alkaline phosphatase, a raised level of bilirubin, abdominal pain, cramping, internal bleeding, and/or ileus.
24 . The method of claim 20 , wherein said symptom of acute graft-versus-host disease is one or more of hyperbilirubinemia, jaundice, portal hypertension, cirrhosis, hemorrhagic conjunctivitis, psudomembrane formation, lagophthalmos, chronic keratoconjunctivitis, sicca, punctuate keratopathy, atrophy of the oral mucosa, erythema, development of lichenoid lesions of the buccal or labial mucosae, bronchiolitis obliterans, vaginitis, vaginal strictures, autoimmune thrombocytopenia, and/or anemia.
25 . The method of claim 21 , wherein said symptom of chronic graft-versus-host disease is one or more of burning sensation in the eye, eye irritation, decreased tear production, photophobia, eye pain due to decreased tear secretion dryness of the mouth, sensitivity to spicy or acidic foods, abdominal pain, dysphagia, odynophagia, weight loss, muscular weakness, neuropathic pain, and/or muscle cramps.
26 . The method of claim 21 , wherein said symptom of acute graft-versus-host disease is one or more of hyperbilirubinemia, jaundice, portal hypertension, cirrhosis, hemorrhagic conjunctivitis, psudomembrane formation, lagophthalmos, chronic keratoconjunctivitis, sicca, punctuate keratopathy, atrophy of the oral mucosa, erythema, development of lichenoid lesions of the buccal or labial mucosae, bronchiolitis obliterans, vaginitis, vaginal strictures, autoimmune thrombocytopenia, and/or anemia.
27 . The method of claim 19 , wherein said graft-versus-host disease is reduced in grade by at least one grade level as a result of said treatment.
28 . The method of claim 27 , wherein said graft-versus-host disease is reduced from grade IV to grade III; from grade IV to grade II; from grade IV to grade I; from grade IV to grade 0; from grade III to grade II; from grade III to grade I; from grade III to grade 0; from grade II to grade I; from grade II to grade 0; or from grade I to grade 0.
29 . The method of claim 19 , wherein said placental stem cells are administered to said individual within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 days of said individual receiving a transplant.
30 . The method of claim 19 , wherein at least one other therapeutic agent is administered to said individual in addition to said placental stem cells.
31 . The method of claim 30 , wherein said at least one other therapeutic agent is an immunosuppressive agent or immunomodulatory agent.
32 . The method of claim 31 , wherein said immunosuppressive agent or immunomodulatory agent is methothrexate, leflunomide, cyclophosphamide, cyclosporine A, a macrolide antibiotic, methylprednisolone, a corticosteroid, a steroid, mycophenolate mofetil, rapamycin, mizoribine, deoxyspergualin, brequinar, malononitriloamindes, a T cell receptor modulator, a cytokine receptor modulator, a peptide mimetic, an antibody, a nucleic acid molecule, a small molecule, an organic compound, or an inorganic compound.
33 . The method of claim 19 , wherein between 1 million and 10 billion placental stem cells are administered.
34 . The method of claim 33 , wherein said placental stem cells are administered directly into an organ.
35 . The method of claim 20 , wherein between 1 million and 10 billion placental stem cells are administered.
36 . The method of claim 35 , wherein said placental stem cells are administered directly into an organ.
37 . The method of claim 21 , wherein between 1 million and 10 billion placental stem cells are administered.
38 . The method of claim 37 , wherein said placental stem cells are administered directly into an organ.