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Safety of stem cell/Fat derived stem cell is reliable and safe.

Fat derived stem cell is free of tumorigenesty (reported by Clinical research institute of SNU)
Fat derived stem cell is free of tumorigenesty (reported by Clinical research institute of SNU)
13-Week Toxicity Test on SCID Mice Carcinogenicity Test on BALB/c-nu Mice
  • Zero mortality, clinical symptoms not observed.
  • No change in weight or water consumption.
  • No significant hematological or serological change.
  • No particular change in urine and eye test results.
  • Sporadic variances in absolute organ mass and
    brelative organ mass were observed,
    but no histopathological issues were found.
  • Conclusion :
    No observed effect level is 2X108 cells/kg B.W
    [1X1010cells for a person weighing 60kg.]
  • No tumor was observed in a 25-week period.
    BALB/c-nu Mouseで発癌性試験
    Negative control
    MRC-5 (human fetal lung cell line)
    Positive control
    A375 (human malignant melanoma cell line)
  • Conclusion :
    No carcinogenic effect at 2X108 cells/kg B.W
    [1X1010 cells for a person weighing 60kg]
No single nucleotide mutation or change in karyotype was detected after 12 passages of fat derived stem cell cultivation.
Karyotype
Karyotype
Katyotype Katyotype Katyotype
SNPs (Single Nucleotide Polymorphisms)
SNPs (Single Nucleotide Polymorphisms)
NO. Sample ID Cell rate Reproducibility
1 P0 99.78% 100.00%
2 P3 99.90% 100.00%
3 P6 99.91% 100.00%
4 P9 99.93% 100.00%
SNPs (Single Nucleotide Polymorphisms)
Stem cell safety related articles
  • Curr Opin Mol Ther. 2010 Aug;12(4):442-9.
    Adipose-derived stem and stromal cells for cell-based therapy: current status of preclinical studies and clinical trials. Mizuno H. Juntendo University School of Medicine, Department of Plastic and Reconstructive Surgery, 2-1-1 Hongo Bunkyo-ku, Tokyo 1138421, Japan. PMID: 20677095
  • Dis Colon Rectum. 2005 Jul;48(7):1416-23.
    A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-Montes JA. Department of General Surgery, La Paz University Hospital, Madrid, Spain. PMID: 15933795
  • Dis Colon Rectum. 2009 Jan;52(1):79-86.
    Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Department of Surgery and Cell Therapy, La Paz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. PMID: 19273960
  • Stem Cells Int. 2010 Oct 31;2010:503593.
    Culture and Use of Mesenchymal Stromal Cells in Phase I and II Clinical Trials. Philippe B, Luc S, Valerie PB, Jerome R, Alessandra BR, Louis C. EFS-PM, Laboratoire d'Ingenierie Cellulaire, GECSoM, 75 rue de Lisieux, 31300 Toulouse, France. PMID: 21052537
  • Arch Pharm Res. 2009 Jan;32(1):117-26. Epub 2009 Jan 29.
    Biological characterization of long-term cultured human mesenchymal stem cells. Kim J, Kang JW, Park JH, Choi Y, Choi KS, Park KD, Baek DH, Seong SK, Min HK, Kim HS. Pharmacological Research Department, National Institute of Toxicological Research, jpnea Food & Drug Administration, Seoul, 122-704, jpnea. PMID: 19183884
  • Cancer Res. 2007 Oct 1;67(19):9142-9.
    Human bone marrow derived mesenchymal stem cells do not undergo transformation after long-term in vitro culture and do not exhibit telomere maintenance mechanisms. Bernardo ME, Zaffaroni N, Novara F, Cometa AM, Avanzini MA, Moretta A, Montagna D, Maccario R, Villa R, Daidone MG, Zuffardi O, Locatelli F. Oncoematologia Pediatrica , Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Universita di Pavia, Pavia, Italy. PMID: 17909019
  • Stem Cells. 2007 Jan;25(1):220-7. Epub 2006 Sep 7.
    In vivo distribution of human adipose-derived mesenchymal stem cells in novel xenotransplantation models. Meyerrose TE, De Ugarte DA, Hofling AA, Herrbrich PE, Cordonnier TD, Shultz LD, Eagon JC, Wirthlin L, Sands MS, Hedrick MA, Nolta JA. Washington University School of Medicine, Division of Oncology, Hematopoietic Development and Malignancy Section, St. Louis, Missouri 63110, USA. PMID: 16960135
Anti-tumor effect of stem cell
  • PLoS One. 2009 Jul 17;4(7):e6278.
    Adult stromal cells derived from human adipose tissue provoke pancreatic cancer cell death both in vitro and in vivo. Cousin B, Ravet E, Poglio S, De Toni F, Bertuzzi M, Lulka H, Touil I, André M, Grolleau JL, Péron JM, Chavoin JP, Bourin P, Pénicaud L, Casteilla L, Buscail L, Cordelier P. Université de Toulouse, UPS, UMR 5241 Métabolisme, Plasticité et Mitochondrie, BP 84225, Toulouse, France. PMID: 19609435
  • BMC Cancer. 2010 Oct 28;10:590.
    Therapy with un-engineered naive rat umbilical cord matrix stem cells markedly inhibits growth of murine lung adenocarcinoma. Maurya DK, Doi C, Kawabata A, Pyle MM, King C, Wu Z, Troyer D, Tamura M. Department of Anatomy & Physiology, Kansas State University, College of Veterinary Medicine, Manhattan, KS 66506, USA. PMID: 21029413
  • Cytotherapy. 2010 Sep;12(5):615-25.
    Mesenchymal stromal cells alone or expressing interferon-beta suppress pancreatic tumors in vivo, an effect countered by anti-inflammatory treatment. Kidd S, Caldwell L, Dietrich M, Samudio I, Spaeth EL, Watson K, Shi Y, Abbruzzese J, Konopleva M, Andreeff M, Marini FC. Section of Molecular Hematology and Therapy, Department of Stem Cell Transplantation and Cellular Therapy, UT-MD Anderson Cancer Center, Houston, TX, USA. PMID: 20230221
  • Cytotherapy. 2009;11(3):289-98, 1 p following 298.
    Therapeutic potential of mesenchymal stromal cells in a mouse breast cancer metastasis model. Sun B, Roh KH, Park JR, Lee SR, Park SB, Jung JW, Kang SK, Lee YS, Kang KS. Zoonotic Disease Institute, College of Veterinary Medicine, Seoul National University, Seoul, jpnea. PMID: 19308770
  • Cancer Lett. 2009 Jul 18;280(1):31-7. Epub 2009 Mar 13.
    Naive human umbilical cord matrix derived stem cells significantly attenuate growth of human breast cancer cells in vitro and in vivo. Ayuzawa R, Doi C, Rachakatla RS, Pyle MM, Maurya DK, Troyer D, Tamura M. Department of Anatomy and Physiology, Kansas State University College of Veterinary Medicine, Manhattan, KS 66506, United States. PMID: 19285791
  • Acta Biochim Biophys Sin (Shanghai). 2010 Dec 31. [Epub ahead of print]
    Inhibition of lung cancer cell proliferation mediated by human mesenchymal stem cells. Li L, Tian H, Chen Z, Yue W, Li S, Li W. Department of Thoracic Surgery, Qilu Hospital, Shandong University, Jinan 250012, China. PMID: 21196449
  • Cell Res. 2008 Apr;18(4):500-7.
    Suppression of tumorigenesis by human mesenchymal stem cells in a hepatoma model.
    Qiao L, Xu Z, Zhao T, Zhao Z, Shi M, Zhao RC, Ye L, Zhang X. Department of Biochemistry, College of Life Sciences, Nankai University, Tianjin 300071, China. PMID: 18364678 
  • J Exp Med. 2006 May 15;203(5):1235-47. Epub 2006 Apr 24.
    Human mesenchymal stem cells exert potent antitumorigenic effects in a model of Kaposi's sarcoma.
    Khakoo AY, Pati S, Anderson SA, Reid W, Elshal MF, Rovira II, Nguyen AT, Malide D, Combs CA, Hall G, Zhang J, Raffeld M, Rogers TB, Stetler-Stevenson W, Frank JA, Reitz M, Finkel T. Laboratory of Molecular Biology, Cardiovascular Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD 20892, USA. PMID: 16636132
  • Exp Mol Pathol. 2003 Dec;75(3):248-55.
    Mesenchymal progenitor cell-mediated inhibition of tumor growth in vivo and in vitro in gelatin matrix. Ohlsson LB, Varas L, Kjellman C, Edvardsen K, Lindvall M. Department of Cell and Molecular Biology, Section for Tumor Immunology, Lund University, Sweden. PMID: 14611816
  • Clin Cancer Res. 2000 Nov;6(11):4351-8.
    Antitumor therapeutic potential of activated human umbilical cord blood cells against leukemia and breast cancer. Joshi SS, Tarantolo SR, Kuszynski CA, Kessinger A. Department of Cell Biology and Anatomy, University of Nebraska Medical Center, Omaha 68198-6395, USA. PMID: 11106253
  • Cell Mol Life Sci. 1999 Apr;55(4):663-7. Factor(s) from nonmacrophage bone marrow stromal cells inhibit Lewis lung carcinoma and B16 melanoma growth in mice. Maestroni GJ, Hertens E, Galli P. Centre for Experimental Pathology, Istituto Cantonale di Patologia, Locarno, Switzerland. PMID: 10357234
  • Cancer Sci. 2010 Dec;101(12):2546-53. doi: 10.1111/j.1349-7006.2010.01738.x. Epub 2010 Oct 7.
    Human mesenchymal stem cells inhibit metastasis of a hepatocellular carcinoma model using the MHCC97-H cell line. Li GC, Ye QH, Xue YH, Sun HJ, Zhou HJ, Ren N, Jia HL, Shi J, Wu JC, Dai C, Dong QZ, Qin LX. Liver Cancer Institute and Zhongshan Hospital, Institutes of Biomedical Science, Fudan University, Shanghai, China; Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education, China. PMID: 20942864