US2013217117A1PendingUtilityA1

Pluripotent stem cells obtained by non-viral reprogramming

Assignee: THOMSON JAMESPriority: Oct 24, 2008Filed: Sep 7, 2012Published: Aug 22, 2013
Est. expiryOct 24, 2028(~2.3 yrs left)· nominal 20-yr term from priority
C12N 2501/605C12N 2501/603C12N 2501/606C12N 5/0696C12N 2501/602C12N 2510/00C12N 2501/604C12N 2501/608C12N 15/85
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Claims

Abstract

Methods for reprogramming primate somatic cells to pluripotency using an episomal vector that does not encode an infectious virus are disclosed. Pluripotent cells produced in the methods are also disclosed.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A population of pluripotent cells produced according to a method comprising the steps of:
 introducing into a primate somatic cell at least one non-viral episomal vector that encodes at least one potency-determining factor under conditions sufficient to reprogram the cell into a pluripotent cell, the at least one vector encoding at least potency-determining factors OCT4 and SOX2, wherein the cell expresses the introduced OCT4 and SOX2 and further comprises SV40 T Antigen; and   culturing the pluripotent cell until it divides into a population of pluripotent cells substantially free of any vector component associated with exposing the potency-determining factors to the somatic cell.   
     
     
         2 . The population of  claim 1 , where the primate somatic cells are obtained from a fetal or post-natal primate individual. 
     
     
         3 . The population of  claim 2 , wherein the primate is human. 
     
     
         4 . The population of  claim 1 , wherein the pluripotent cells are genetically identical to a post-natal individual. 
     
     
         5 . The population of  claim 1 , wherein at least one vector further encodes at least one potency-determining factor selected from the group consisting of LIN28, NANOG, c-Myc, and KLF4. 
     
     
         6 . The population of  claim 1 , wherein a single vector encodes at least OCT4 and SOX2 and comprises at least one operably-positioned internal ribosome entry site. 
     
     
         7 . The population of  claim 6 , wherein the single vector comprises, in order, a first promoter, OCT4, IRES2, SOX2, a second promoter, SV40 T antigen, IRES2, and KLF4. 
     
     
         8 . The population of  claim 6 , wherein the vector comprises, in order, a first promoter, OCT4, IRES2, SOX2, a second promoter, c-Myc, IRES2, KLF4, a third promoter, NANOG, IRES2, and LIN28. 
     
     
         9 . The population of  claim 1 , wherein a first vector comprises, in order, a first promoter, OCT4, IRES2, SOX2, a second promoter, SV40 T antigen, IRES2, and KLF4, wherein a second vector comprises, in order, a third promoter, OCT4, IRES2, SOX2, a fourth promoter, NANOG, IRES2, and KLF4, and wherein a third vector comprises, in order, a fifth promoter, c-Myc, IRES 2, and LIN28, wherein the promoters need not be identical. 
     
     
         10 . The population of  claim 9 , wherein each of the first, second, third, and fourth promoters is an elongation factor 1α (EF1α) gene promoter. 
     
     
         11 . The population of  claim 1 , wherein a first vector comprises, in order, a first promoter, OCT4, IRES2, SOX2, a second promoter, KLF4, IRES2, c-Myc, a third promoter, NANOG, IRES2, and LIN28, wherein a second vector comprises, in order, a fourth promoter, OCT4, IRES2, SOX2, a fifth promoter, SV40 T antigen, IRES2, and KLF4, wherein the promoters need not be identical. 
     
     
         12 . The population of  claim 11 , wherein each of the first, third, fourth, and fifth promoters is an EF1α gene promoter and wherein the second promoter is a cytomegalovirus immediate early gene (CMV) promoter. 
     
     
         13 . The population of  claim 1  wherein a first vector comprises, in order, a first promoter, OCT4, IRES2, SOX2, a second promoter, NANOG, IRES2, and LIN28, wherein a second vector comprises, in order, a third promoter, OCT4, IRES2, SOX2, a fourth promoter, SV40 T antigen, IRES2, and KLF4, and wherein a third vector comprises, in order, a fifth promoter, OCT4, IRES2, SOX2, a sixth promoter, c-Myc, IRES 2, and KLF4, wherein the promoters need not be identical. 
     
     
         14 . The population of  claim 1 , wherein at least one vector encodes a plurality of factors and at least one vector comprises at least one internal ribosomal entry site. 
     
     
         15 . The population of  claim 1 , wherein OCT4 and SOX2 are human. 
     
     
         16 . The population of  claim 1 , wherein LIN28, NANOG, c-Myc, and KLF4 are human. 
     
     
         17 . A population of pluripotent cells substantially cured of exogenously introduced vector components. 
     
     
         18 . The population of  claim 17 , wherein the cells are primate cells. 
     
     
         19 . The population of  claim 18 , wherein the primate cells are human cells. 
     
     
         20 . The population of  claim 17 , wherein the human cells are genetically identical to cells of a post-natal primate individual. 
       
         
           
                 
               
                   TABLE 1 
                 
                     
                 
                   Reprogramming genes and translation elements 
                 
                 
                 
                 
                 
                 
               
                     
                     
                     
                     
                   Accession # or 
                 
                   Gene Symbol 
                   Abbr. 
                   Source 
                   SEQ ID NO 
                   sequence 
                 
                     
                 
                 
                 
                 
                 
                 
               
                   OCT4 
                   O 
                   hESC 
                   1 
                   NM_002701 
                 
                   SOX2 
                   S 
                   hESC 
                   2 
                   NM_003106 
                 
                   NANOG 
                   N 
                   hESC 
                   3 
                   NM_024865 
                 
                   LN28 
                   L 
                   hESC 
                   4 
                   NM_024674 
                 
                   c-Myc 
                   M 
                   hESC 
                   5 
                   NM_002467 
                 
                   KLF4 
                   K 
                   hESC 
                   6 
                   NM_004235 
                 
                   SV40 T 
                   T 
                   pBABE-puro 
                   7 
                   EF579667 
                 
                     
                     
                   SV40 LT p 
                 
                   TERT 
                   TERT 
                   pBABE-hygro- 
                   8 
                   NM_198253 
                 
                     
                     
                   hTERT 
                 
                   IRES1 
                   1 
                   pIRESpuro3 
                   — 
                 
                   IRES2 
                   2 
                   pIRES2EGFP 
                   — 
                 
                   F2A 
                   F2A 
                   (synthesized) 
                   9 
                 
                   CMV 
                   C 
                     
                   10 
                 
                   EF1α 
                   E 
                     
                   11 
                 
                   EF2α 
                   — 
                     
                   12 
                 
                     
                 
             
                
               
               
                
                
               
            
             
                
                
                
               
            
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           
                 
               
                   TABLE 2 
                 
                     
                 
                   Episomal constructs 
                 
                 
                 
                 
                 
               
                     
                   # 
                   Name 
                   Size (bp) 
                 
                     
                     
                 
                     
                    1 
                   pCEP4-EGFP 
                   10984 
                 
                     
                    2 b   
                   pEP4-E-O2S(2) 
                   13523 
                 
                     
                    3 b   
                   pEP4-E-M2K 
                   14293 
                 
                     
                    4 a   
                   pCEP4-M2K 
                   13643 
                 
                     
                    5 b   
                   pEP4-E-K2M 
                   14268 
                 
                     
                    6 a   
                   pCEP4-K2M 
                   13636 
                 
                     
                    7 b   
                   pEP4-E-N2K 
                   13819 
                 
                     
                    8 b   
                   pEP4-E-T2K 
                   15071 
                 
                     
                    9 a   
                   pCEP4-M2L 
                   12852 
                 
                     
                   10 b   
                   pEP4-E-N2L 
                   13020 
                 
                     
                   11 b   
                   pEP4-E-T2L 
                   14284 
                 
                     
                   12 c   
                   pEP4-E-O2S-C-M2K 
                   16038 
                 
                     
                   13 c   
                   pEP4-E-O2S-E-M2K 
                   16680 
                 
                     
                   14 c   
                   pEP4-E-O2S-C-K2M 
                   16010 
                 
                     
                   15 c   
                   pEP4-E-O2S-E-K2M 
                   16652 
                 
                     
                   16 c   
                   pEP4-E-O2S-E-N2K 
                   16206 
                 
                     
                   17 c   
                   pEP4-E-O2S-E-T2K 
                   17458 
                 
                     
                   18 c   
                   pEP4-E-O2S-E-N2L 
                   15415 
                 
                     
                   19 c   
                   pEP4-E-O2S-E-T2L 
                   16679 
                 
                     
                   20 c   
                   pEP4-O2S-C-M2L 
                   15247 
                 
                     
                   21 c   
                   pEP4-E-O2S-E-K2T 
                   17474 
                 
                     
                   22 c   
                   pEP4-E-O2S-C-M2L-E-N2K 
                   19956 
                 
                     
                   23 c   
                   pEP4-E-O2S-C-M2K-E-N2L 
                   19956 
                 
                     
                   24 c   
                   pEP4-E-O2S-C-K2M-E-N2L 
                   19949 
                 
                     
                   25 c   
                   pEP4-E-O2S-C-M2L-E-T2K 
                   21220 
                 
                     
                   26 c   
                   pEP4-E-O2S-C-M2K-E-T2L 
                   21220 
                 
                     
                   27 c   
                   pEP4-E-O2S-C-K2M-E-T2L 
                   21213 
                 
                     
                   28 c   
                   pEP4-E-O2S-C-M2L-E-K2T 
                   21224 
                 
                     
                     
                 
                     
                     a All linked gene cassettes were cloned into the pCEP4-EGFP between BamHI and NheI restriction sites. 
                 
                     
                     b All linked gene cassettes plus the EF1α promoter were cloned into the pCEP4-EGFP between BamHI and SpeI (19) restriction sites. 
                 
                     
                     c All expression cassettes were cloned into the pCEP4-EGFP between BamHI and NruI restriction sites. 
                 
             
                
               
               
                
                
               
            
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         
           
                 
               
                   TABLE 3 
                 
                     
                 
                   Combinations of episomal constructs tested for reprogramming activity 
                 
                 
                 
                 
                 
                 
                 
               
                   Equiv- 
                     
                     
                     
                     
                     
                 
                   alent of 
                     
                     
                     
                     
                   AP+ 
                 
                   pCEP4- 
                   Test 
                     
                     
                   Morph. 
                   colony/ 
                 
                   EGF(μg) 
                   # 
                   Plasmids 
                   μg 
                   Changes 
                   plate 
                 
                     
                 
                 
               
                   EXPERIMENT 1 
                 
                 
                 
                 
                 
                 
                 
               
                   6.3 
                    1 
                   pEP4-E-O2S-C-M2K 
                   9.2 
                   +/− 
                   0 
                 
                   6.3 
                    2 
                   pEP4-E-O2S-K2Neo 
                   9.3 
                   +/− 
                   0 
                 
                   6.3 
                     
                   pCEP4-M2L 
                   7.4 
                 
                   6.3 
                    3 
                   pEP4-E-O2S-E-N2K 
                   9.3 
                   +/− 
                   0 
                 
                   6.3 
                     
                   pCEP4-M2L 
                   7.4 
                 
                   6.3 
                    4 
                   pEP4-E-O2S-E-T2K 
                   10 
                   +++ 
                   0 
                 
                   6.3 
                     
                   pCEP4-M2L 
                   7.4 
                 
                   6.3 
                    5 
                   pEP4-E-O2S-E-TERT2K 
                   10.8 
                   +/− 
                   0 
                 
                   6.3 
                     
                   pCEP4-M2L 
                   7.4 
                 
                   6.3 
                    6 
                   pEP4-E-O2S-C-M2L 
                   8.7 
                   +/− 
                   0 
                 
                   6.3 
                     
                   pEP4-E-N2K 
                   7.9 
                 
                   6.3 
                    7 
                   pEP4-E-O2S-C-M2L 
                   8.7 
                   + 
                   0 
                 
                   6.3 
                     
                   pEP4-E-T2K 
                   8.6 
                 
                   6.3 
                    8 
                   pEP4-E-O2S-C-M2L 
                   8.7 
                   +/− 
                   0 
                 
                   6.3 
                     
                   pEP4-E-TERT2K 
                   9.4 
                 
                 
               
                   EXPERIMENT 2 
                 
                 
                 
                 
                 
                 
                 
               
                   3.3 
                    1 
                   pEP4-E-O2S-C-M2K 
                   5.0 
                   +/− 
                   0 
                 
                   3.3 
                    2 
                   pEP4-E-O2S-E-M2K 
                   5.0 
                   +/− 
                   0 
                 
                   3.3 
                    3 
                   pEP4-E-O2S-C-K2M 
                   5.0 
                   +/− 
                   0 
                 
                   3.3 
                    4 
                   pEP4-E-O2S-E-K2M 
                   5.0 
                   +/− 
                   0 
                 
                   2.5 
                    5 
                   pEP4-E-O2S(2) 
                   3.0 
                   +/− 
                   0 
                 
                   2.5 
                     
                   pCEP4-M2K 
                   3.0 
                 
                   2.5 
                    6 
                   pEP4-E-O2S(2) 
                   3.0 
                   +/− 
                   0 
                 
                   2.3 
                     
                   pEP4-E-M2K 
                   3.0 
                 
                   2.5 
                    7 
                   pEP4-E-O2S(2) 
                   3.0 
                   +/− 
                   0 
                 
                   2.5 
                     
                   pCEP4-K2M 
                   3.0 
                 
                   2.5 
                    8 
                   pEP4-E-O2S(2) 
                   3.0 
                   +/− 
                   0 
                 
                   2.3 
                     
                   pEP4-E-K2M 
                   3.0 
                 
                   1.7 
                    9N 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.5 
                     
                   pEP4-E-N2K 
                   2.0 
                 
                   1.7 
                     
                   pCEP4-M2L 
                   2.0 
                   +/− 
                   0 
                 
                   1.7 
                   10N 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.7 
                     
                   pEP4-E-N2L 
                   2.0 
                 
                   1.7 
                     
                   pCEP4-M2K 
                   2.0 
                 
                   1.7 
                   11N 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.7 
                     
                   pEP4-E-N2L 
                   2.0 
                 
                   1.5 
                     
                   pEP4-E-M2K 
                   2.0 
                 
                   1.7 
                   12N 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.7 
                     
                   pEP4-E-N2L 
                   2.0 
                 
                   1.7 
                     
                   pCEP4-K2M 
                   2.0 
                 
                   1.7 
                   13N 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.7 
                     
                   pEP4-E-N2L 
                   2.0 
                 
                   1.5 
                     
                   pEP4-E-K2M 
                   2.0 
                 
                   2.3 
                   14N 
                   pEP4-E-O2S-E-N2K 
                   3.5 
                   +/− 
                   0 
                 
                   2.1 
                     
                   pCEP4-M2L 
                   2.5 
                 
                   2.5 
                   15N 
                   pEP4-E-O2S-E-N2L 
                   3.5 
                   +/− 
                   0 
                 
                   2.1 
                     
                   pCEP4-M2K 
                   2.5 
                 
                   2.5 
                   16N 
                   pEP4-E-O2S-E-N2L 
                   3.5 
                   +/− 
                   0 
                 
                   1.9 
                     
                   pEP4-E-M2K 
                   2.5 
                 
                   2.5 
                   17N 
                   pEP4-E-O2S-E-N2L 
                   3.5 
                   +/− 
                   0 
                 
                   2.1 
                     
                   pCEP4-K2M 
                   2.5 
                 
                   2.5 
                   18N 
                   pEP4-E-O2S-E-N2L 
                   3.5 
                   +/− 
                   0 
                 
                   1.9 
                     
                   pEP4-E-K2M 
                   2.5 
                 
                 
               
                   EXPERIMENT 3 
                 
                 
                 
                 
                 
                 
                 
               
                   1.7 
                    9T 
                   pEP4-E-O2S(2) 
                   2.0 
                   ++ 
                   0 
                 
                   1.4 
                     
                   pEP4-E-T2K 
                   2.0 
                 
                   1.7 
                     
                   pCEP4-M2L 
                   2.0 
                 
                   1.7 
                   10T 
                   pEP4-E-O2S(2) 
                   2.0 
                   + 
                   0 
                 
                   1.5 
                     
                   pEP4-E-T2L 
                   2.0 
                 
                   1.7 
                     
                   pCEP4-M2K 
                   2.0 
                 
                   1.7 
                   11T 
                   pEP4-E-O2S(2) 
                   2.0 
                   + 
                   0 
                 
                   1.5 
                     
                   pEP4-E-T2L 
                   2.0 
                 
                   1.5 
                     
                   pEP4-E-M2K 
                   2.0 
                 
                   1.7 
                   12T 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.5 
                     
                   pEP4-E-T2L 
                   2.0 
                 
                   1.7 
                     
                   pCEP4-K2M 
                   2.0 
                 
                   1.7 
                   13T 
                   pEP4-E-O2S(2) 
                   2.0 
                   +/− 
                   0 
                 
                   1.5 
                     
                   pEP4-E-T2L 
                   2.0 
                 
                   1.5 
                     
                   pEP4-E-K2M 
                   2.0 
                 
                   2.2 
                   14T 
                   pEP4-E-O2SET2K 
                   3.5 
                   +++ 
                   0 
                 
                   2.1 
                     
                   pCEP4-M2L 
                   2.5 
                 
                   2.3 
                   15T 
                   pEP4-E-O2S-E-T2L 
                   3.5 
                   + 
                   0 
                 
                   2.1 
                     
                   pCEP4-M2K 
                   2.5 
                 
                   2.3 
                   16T 
                   pEP4-E-O2S-E-T2L 
                   3.5 
                   + 
                   0 
                 
                   1.9 
                     
                   pEP4-E-M2K 
                   2.5 
                 
                   2.3 
                   17T 
                   pEP4-E-O2S-E-T2L 
                   3.5 
                   +/− 
                   0 
                 
                   2.1 
                     
                   pCEP4-K2M 
                   2.5 
                 
                   2.3 
                   18T 
                   pEP4-E-O2S-E-T2L 
                   3.5 
                   +/− 
                   0 
                 
                   1.9 
                     
                   pEP4-E-K2M 
                   2.5 
                 
                   1.9 
                   19 
                   pEP4-E-O2S-E-T2K 
                   3.0 
                   +++ 
                   1 
                 
                   2.0 
                     
                   pEP4-E-O2S-E-N2K 
                   3.0 
                 
                   1.7 
                     
                   pCEP4-M2L 
                   2.0 
                 
                 
               
                   EXPERIMENT 4 
                 
                 
                 
                 
                 
                 
                 
               
                   6 
                    1 
                   pEP4-E-O2S-C-M2K-E- 
                   10.9 
                   +/− 
                   0 
                 
                     
                     
                   N2L 
                 
                   4 
                    2 
                   pEP4-E-O2S-C-M2K-E- 
                   7.3 
                   +++ 
                   0 
                 
                     
                     
                   N2L 
                 
                   2 
                     
                   pEP4-E-O2S-E-T2K 
                   3.2 
                 
                   6 
                    3 
                   pEP4-E-O2S-C-K2M-E- 
                   10.9 
                   +/− 
                   0 
                 
                     
                     
                   N2L 
                 
                   4 
                    4 
                   pEP4-E-O2S-C-K2M-E- 
                   7.3 
                   ++ 
                   2 
                 
                     
                     
                   N2L 
                 
                   2 
                     
                   pEP4-E-O2S-E-T2K 
                   3.2 
                 
                   3 
                    5 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   +/− 
                   0 
                 
                   3 
                     
                   pEP4-E-O2S-E-M2K 
                   4.6 
                 
                   3 
                    6 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   ++ 
                   0 
                 
                   2 
                     
                   pEP4-E-O2S-E-T2K 
                   3.2 
                 
                   3 
                     
                   pEP4-E-O2S-E-M2K 
                   4.6 
                 
                   3 
                    7 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   +/− 
                   0 
                 
                   3 
                     
                   pEP4-E-O2S-C-M2K 
                   4.4 
                 
                   3 
                    8 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   + 
                   0 
                 
                   2 
                     
                   pEP4-E-O2S-E-T2K 
                   3.2 
                 
                   3 
                     
                   pEP4-E-O2S-C-M2K 
                   4.4 
                 
                   3 
                    9 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   +/− 
                   0 
                 
                   3 
                     
                   pEP4-E-O2S-E-K2M 
                   4.5 
                 
                   3 
                   10 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   +/− 
                   0 
                 
                   2 
                     
                   pEP4-E-O2S-E-T2K 
                   3.2 
                 
                   3 
                     
                   pEP4-E-O2S-E-K2M 
                   4.5 
                 
                   3 
                   11 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   +/− 
                   0 
                 
                   3 
                     
                   pEP4-E-O2S-C-K2M 
                   4.4 
                 
                   3 
                   12 
                   pEP4-E-O2S-E-N2L 
                   4.2 
                   + 
                   0 
                 
                   2 
                     
                   pEP4-E-O2S-E-T2K 
                   3.2 
                 
                   3 
                     
                   pEP4-E-O2S-C-K2M 
                   4.4 
                 
                   2 
                   13 
                   pEP4-E-O2S-C-M2L-E- 
                   3.9 
                   + 
                   0 
                 
                     
                     
                   T2K 
                 
                   4 
                     
                   pEP4-E-O2S-E-N2K 
                   5.9 
                 
                   6 
                   14 
                   pEP4-E-O2S-C-M2K-E- 
                   11.6 
                   + 
                   0 
                 
                     
                     
                   T2L 
                 
                   3 
                   15 
                   pEP4-E-O2S-C-M2K-E- 
                   5.8 
                   + 
                   0 
                 
                     
                     
                   T2L 
                 
                   3 
                     
                   pEP4-E-O2S-E-N2K 
                   4.4 
                 
                   6 
                   16 
                   pEP4-E-O2S-C-K2M-E- 
                   11.6 
                   +/− 
                   0 
                 
                     
                     
                   T2L 
                 
                   3 
                   17 
                   pEP4-E-O2S-C-K2M-E- 
                   5.8 
                   + 
                   0 
                 
                     
                     
                   T2L 
                 
                   3 
                     
                   pEP4-E-O2S-E-N2K 
                   4.4 
                 
                   6 
                   18 
                   pEP4-E-O2S-C-M2L-E- 
                   11.6 
                   +/− 
                   0 
                 
                     
                     
                   K2T 
                 
                   3 
                   19 
                   pEP4-E-O2S-C-M2L-E- 
                   5.8 
                   +/− 
                   0 
                 
                     
                     
                   K2T 
                 
                   3 
                     
                   pEP4-E-O2S-E-N2K 
                   4.4 
                 
                   3 
                   20 
                   pEP4-E-O2S-E-K2T 
                   4.8 
                   +/− 
                   0 
                 
                   3 
                     
                   pEP4-E-O2S-E-N2K 
                   4.4 
                 
                   2 
                     
                   pEP4-E-O2S-C-M2L 
                   2.8 
                 
                     
                 
                   +/−: No or very few colonies with morphological change were observed (FIG. 4B). 
                 
                   +, ++ and +++: Different number (from less to more) of colonies with morphological change were observed.

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