Compositions Comprising Human Embryonic Stem Cells and Their Derivatives, Methods of Use, and Methods of Preparation

Abstract

The present invention relates to a pharmaceutical composition comprising of preparations of human embryonic stem (hES) cells and their derivatives and methods for their transplantation into the human body, wherein transplantation results in the clinical reversal of symptoms, cure, stabilization or arrest of degeneration of a wide variety of presently incurable and terminal medical conditions, diseases and disorders. The invention further relates to novel processes of preparing novel stem cell lines which are free of animal products, feeder cells, growth factors, leukaemia inhibitory factor, supplementary mineral combinations, amino acid supplements, vitamin supplements, fibroblast growth factor, membrane associated steel factor, soluble steel factor and conditioned media. This invention further relates to the isolation, culture, maintenance, expansion, differentiation, storage, and preservation of such stem cells.

What is claimed is: 
     
         1 . A pharmaceutical composition for the treatment of a disease, disorder, or condition, comprising a therapeutically effective amount of human embryonic stem cells free from feeder cells, animal products, growth factors, leukemia inhibiting factor, fibroblast growth cells, vitamin supplements, membrane associated steel factor, soluble steel factor, and conditioned media, wherein said human embryonic stem cells are suspended in a pharmaceutically acceptable biocompatible solution, and wherein the disease, disorder, or condition is selected from the group consisting of ankylosing spondylitis, aphthous ulcers, thrombocytopenia, multiple sclerosis, psoriasis, sarcoidosis, Steven Johnson syndrome, systemic lupus erythematosus, arthritis, ulcerative colitis, acute myeloid leukemia, polycythaemia vera, thalassemia, brain damage, cerebrovascular injury, cerebrovascular attack, stroke, cancer, autism, cerebral palsy, Down's syndrome, eye disorders, optic nerve atrophy, retinitis pigmentosa, macular degeneration, phthisis bulbi, amyotrophic lateral sclerosis, Alzheimer's disease, cerebellar ataxia, corticobasal degeneration, dementia, post-electric shock encephalopathy, post-rabies vaccine encephalopathy, hereditary spino motor neuron disease, Huntington Chorea, motor neuron disease, olivopontocerebellar atrophy, Parkinson's Disease, progressive supranuclear palsy, Becker muscular dystrophy, Duchenne muscular dystrophy, fascio scapular muscular dystrophy, limb-girdle muscular dystrophy, restrictive cardiomyopathy, osteoporosis, spinal muscular dystrophy, spinal cord injury, brachial plexus injury, bed sores, burns, myocardial infarction, diabetes mellitus, kidney disorders, osteoarthritis, liver disorders, lung disorders, testicular atrophy, vascular disorders, and reproductive disorders. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the human embryonic stem cells are from a pre-blastocyst stage embryo. 
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein the embryo is a 2 to 7 day old embryo. 
     
     
         4 . The pharmaceutical composition of  claim 2 , wherein the embryo is a 2 to 4 day old embryo. 
     
     
         5 . The pharmaceutical composition of  claim 2 , wherein the embryo is a 2 day old embryo. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the composition is in a ready-to-use form. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the composition comprises a therapeutically effective amount of neuronal progenitor stem cells. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the composition comprises a therapeutically effective amount of non-neuronal progenitor stem cells. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the disease, disorder, or condition is selected from the is selected from the group consisting of aphthous ulcers, multiple sclerosis, psoriasis, arthritis, cerebrovascular injury, cerebrovascular attack, stroke, autism, cerebral palsy, Down's syndrome, optic nerve atrophy, cerebellar ataxia, motor neuron disease, olivopontocerebellar atrophy, Parkinson's Disease, Duchenne muscular dystrophy, spinal cord injury, brachial plexus injury, burns, diabetes mellitus, and lung disorders. 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the disease, disorder, or condition is selected from the group consisting of ankylosing spondylitis, sarcoidosis, systemic lupus erythematosus, acute myeloid leukemia, brain damage, and cancer. 
     
     
         11 . A method of treating a disease, disorder, or condition, comprising administering a therapeutically effective amount of human embryonic stem cells free from feeder cells, animal products, growth factors, leukemia inhibiting factor, fibroblast growth cells, vitamin supplements, membrane associated steel factor, soluble steel factor, and conditioned media, wherein the human embryonic stem cells are administered by local application, subcutaneous injection, intramuscular injection, intravenous injection, oral spray, intervaginal application, deep spinal injection, caudal injection, lumbar puncture, epidural injection, epidural catheter infusion, local eye drops, local ear drops, nebulizer, intra-articular injection, brachial plexus injection, retroorbital injection, or topical administration. 
     
     
         12 . The method of  claim 11 , wherein the human embryonic stem cells are from a pre-blastocyst stage embryo. 
     
     
         13 . The method of  claim 12 , wherein the embryo is a 2 to 7 day old embryo. 
     
     
         14 . The method of  claim 12 , wherein the embryo is a 2 to 4 day old embryo. 
     
     
         15 . The method of  claim 12 , wherein the embryo is a 2 day old embryo. 
     
     
         16 . The method of  claim 11 , wherein the therapeutically effective amount of human embryonic stem cells is about 750,000 to about 160 million cells. 
     
     
         17 . The method of  claim 11 , wherein the human embryonic stem cells were obtained by expanding in a cell culture medium consisting of minimal essential medium, a progestin, and a βhCG agonist. 
     
     
         18 . The method of  claim 11 , wherein the human embryonic stem cells contain no more than 40% undifferentiated stem cells. 
     
     
         19 . The method of  claim 11 , wherein the human embryonic stem cells are administered by subcutaneous injection, intramuscular injection, intravenous injection, oral spray, deep spinal injection, caudal injection, lumbar puncture, epidural injection, epidural catheter infusion, nebulizer, intra-articular injection, retroorbital injection, or topical administration.