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Fetal Cell Technologies International

For Immediate Release

It has come to the attention of Precursor Stemcells Technologies, Inc. (PSCT) that certain ignorant and selfish parties have made wild, irresponsible and unsubstantiated accusations that has undermined our therapy to the point of calling it ‘risky’.

While they may be experts in their individual fields, their accusations only reflect their lack of understanding and misinterpretation of the subject on Cell Tissue Transplantation. There is a whole lot of confusion between Cell Tissue Transplantation involving implantation of precursor cells and tissue fragments and Organ Transplantation as the word ‘Xenotransplantation’ generally covers both Cell Tissue Transplantation and Organ Transplantation. In organ transplantation, immuno suppressants are required because there is an existing danger of rejection. But in Cell Tissue Transplantation, there are no organs involved in precursor cells and tissue fragment transplantation, no immuno suppressive drugs are required because there are no immuno rejections.

A. The ‘experts’ should educate their ‘lack of understanding in the field of     xenotransplantation and learn to identify the differences between organs and     Precursor (Progenitor) Cells’ by delving more into the following:

a) Main cells of the same organ are the same, (or almost the same) regardless of the     species of origin i.e. corresponding cells of identical organs (or tissues) of various     animal species (including man) are biologically similar.

b) There are no antigenic differences between the corresponding cells of organs and     tissues of humans and animals of different taxonomic groups.

a) If stem cell transplant implanted into a patient is the same as that of diseased     organ or tissue, then transplanted cells incorporate in the diseased organ or
    tissue, with therapeutic effect. This has long been proven with Isotropic tests of
    Published Clinical Studies in Europe including Authoritative Books on Cell Therapy
    often referred to by Cell Therapists Worldwide until today including those wrote by
    renowned cell therapists; Prof. Dr. F. Schmid, Dr. J. Stein – Cell Research and
    Cellular Therapy (OTT Publishers Thoune, Switzerland) with contributions of:
    Privatdozent Dr. G. Andres (Mainz), Prof. Dr. P. Bernhard (Duisburg), Dr. S.
    Dornbusch (Weisbaden), Prof. Dr. H. Hoepke (Heidelberg), Privatdozent Dr. K.
    Neumann (Cologne), Prof. Dr. F. Schmid (Heidelberg), Prof. Dr. H. Schmidt (Bern),
    Dr. J. Stein (Heidelberg), Prof. Dr. P. Uhlenbruck (Cologne) Prof. Dr. A. Valls
    Conforto (Barcelona). And another well known book in Cell Therapy namely Cell
    Therapy: A New Dimension of Medicine (OTT Publishers Thoune, Switzerland) by
    Prof. Dr. Franz Schmid.

b) If stem cell transplant implanted into a patient is the same as that of normal
    (‘non-diseased’) organ or tissue, then transplanted cells disperse throughout the
    organism of a patient, without any therapeutic effect. (Halsted principle, 1909)

3) PRINCIPLE OF HOMOLOGY All biological systems not only employ similar
    principlesof cell structure and organization, they are also composed of the same
    type ofchemical molecules. Proteins from various organisms of different species are
    homologous of each other: it means their similarity is significant over the entire
    amino acid sequence. Homologous proteins carry out similar functions. Similarity of
    the amino acid sequence is an indication that homologous proteins evolved from a
    common ancestor, and thus belong to the same ‘family’.

4) SIMILARITY IN GENETICS The central dogma of molecular biology states that
    DNAdirects synthesis of RNA, and in turn RNA directs the assembly of all proteins’.
    Thisapplies to all known living organisms. Genetic encoding is universal, the same
    forall known organisms, which implies that life on Earth has evolved only once.
    ‘Families’ of similar genes encode proteins with similar or related functions.’

5) LIFE CYCLE OF CELLS A cell in an organism is not a steady-state system. The
    course of its life also known as the “cell cycle” is dynamic and controlled by an
    internal clock. Cell replication is encoded by DNA and executed by proteins. This
    cell replication sets off a process of cell growth whereby DNA is duplicated and
    proteins are made. This is followed by cell division, when two daughter cells arise.
    The new cells replace worn out cells or add to the cell count depending on what
    the body needs.

a) Precursor cells have high level of readiness to differentiate and to undergo
    changes in response to environmental stimuli and in accordance with their own
    make-up genetic

Comparative Microphotographs of stem cell transplants (Islets of Pancreas) from rabbit and human
Adult Rabbit   Adult Human
Rabbit Fetus   Human fetus
Native Precursor Xenotransplantation   Cell Stained Precursor Cell
Comparative Microphotographs of stem cell transplants (Hepar) from rabbit and human
Adult Rabbit   Adult Human
Rabbit Fetus   Human fetus
Native Precursor Xenotransplantation   Cell Stained Precursor Cell Xenotransplantation

b) They are easily adaptable, due to the plasticity of tissues, which gradually     decreases with each successive precursor stage, and disappears at the end of     development. This includes growth, migration, mobility, ability to create and
    cell-to-cell contacts.

c) Among all the cell types, precursor cells have the highest frequency and speed of cell
   division, and proliferation, which diminish with advancing development.

In the 1930s, Swiss surgeon Prof. Dr Niehans discovered that cells derived from organs of fetal sheep could be injected into the human body without triggering the natural defence mechanism. Since then, cell therapies have been widely used in Switzerland, Germany, Austria, Italy, Russia and many parts of Europe with positive results as a form of ‘Individualised Therapy’ where the physician would prescribe a set of cells for a particular disease and individually prepared for a particular patient.

  1. Why Rabbits?

PSCT select rabbits (and veterinarians would know why) as the perfect animal source of Precursor Stem Cells based on the followings:

  1. The natural barrier has been known to prevent transmission of infections between species to a substantial degree.

  2. The more distant the species are, the stronger has been this natural barrier. It has been 100% true between rabbit and man. To-date there has been no reports of rabbit-to-man transmission of any virus. It is a common knowledge that none of the known viral diseases of rabbits are transmissible to man. There has been no medical nor scientific literature on transmission of diseases or viruses from rabbits to human.

  3. No retrovirus has been found in rabbits to-date! There is no argument about the existence of retroviruses other animal species, but no one has been able to find any retroviruses in rabbits as yet.

  4. Coming from a healthy closed colony, the fetal and newborn rabbits have been found remarkably free of any disease.

  5. Rabbit insulin differs from human just by two amino acids, and is therapeutically as effective as porcine, which is widely used in human medicine.

This is also further proven by the following scientific publications:

1. Murphy F.A., Fauquet C.M., Bishop D.H.L., et al.: Virus Taxonomy (Sixth Report of the International Committee on Taxonomy of Viruses), Springer Verlag, Vienna – New York, 1995, pp 23 – 42, and update of 2000

>2. Fauquet C.M., Pringle C.R.: Abbreviations for vertebrate virus species names. Arch Virology 144, 1999, 1865 -1880

3. Murphy A.F., Gibbs E.P.J., Horzinek M.C., Studdert M.J.: Veterinary Virology, Academic Press, San Diego, New York, London, 1999, pp273 – 278.

Closed colony is an enclosed unit, suitably ecologically located, where animals (rabbits) of selected genetic lineages, are bred and reared for generations, in order to be protected from dangers of the surrounding world to the highest degree possible by ecological means.?

They cannot get infected from other rabbits, or other animals, or by insects or vermin, or by humans: only a minimum number of rabbit handlers, and a veterinarian, are permitted an entry into the closed colony, and all these humans are subjected to regular medical examinations, are properly attired, and are excluded from entry when ill.

When a new closed colony is established, the group of rabbits, obtained? from another closed colony, has to be bred and reared together for at least? 25? generations, i.e. around 30 months, before the colony can receive a certification of ‘closed colony’.

During this time of observation, any genetic abnormalities, carrier-state of dormant infections, and other pathological conditions, etc., become noticeable in the new rabbit colony, and the affected animals are eliminated.

The rabbits are observed daily by qualified personnel, and at least once a week by a veterinarian.

The medical record of each rabbit is kept indefinitely, and is linked to those of its predecessors for generations back. Thus the health status of the whole colony can be evaluated instantly, also historically during its entire existence.

Our cells are obtained from rabbits that are bred in a closed colony since 1973 that complies fully with European Union Good Manufacturing Practice since 2006 and awarded with the European Union Certification for Closed Colony of Animals (30 generations) since 2004. The rabbits have been closely monitored throughout this period to ensure that they are free of diseases before they are eligible for cell therapy culturing.

Precursor stem cells (or also known as progenitor cells) are partially differentiated cells that are capable of dividing and differentiating into a particular cell. PSCT uses precursor stem cells procured from rabbit fetus bred in closed colony. The stem cells are individually prepared for each patient and our method of manufacturing incorporates all the pertinent requirements of “U.S. Public Health Service Guidelines on Infectious Disease Issues in Xenotransplantation” of 19 January 2001 (Federal Register, Volume 66, Number 19, pages 8120-1) which was initially drafted on 23 September 1996.

PSCT reiterates that these completely baseless accusations are due to lack of knowledge and understanding of PSCT’s proprietary therapy and method of culturing precursor stem cells.

This is also further proven by the following scientific publications:

1. Ricordi. C, Lacy, P, Sterbenz, K, Davie .1. Low-temperature culture of human
    islets or in vivo treatment with L3T4 antibody produces a marked prolongation
    of islet human-to mouse xenograft survival, Proc Nail Acad Sc USA I 987;
2. Falqui, L, Finke. E.Caret, J-C.et al. Marked prolongation of human islet
    xenograft survival (human-to-mouse) by low temperature culture and
    temporary immunosuppressjon with human and mouse antilymphocyte sera.
    Transplantation 1991; 51:1322-1324
3. Goss, J, Flake, E, Flyc, W, Lacy, P. Induction of immune unrespon-siveness to
    concordant islet xenografts by intraheparic preimmunization and transient
    immunsuppression J Clin Invest 1994; 93:1312-13 14
4. West, L, Morris, P, Wood K. Fetal liver haermatopoietic cells and tolerance to
    organ allografls. Lancet 1994; 343:148-149
5. Yu, S. Nakafusa, Y, Flyc, W. Portal vein administration of donor cells promotes
    peripheral allospecific byporesponsiveness and graft tolerance. Surgery 1994;
6. Gaines, B, Colson, Y, Kaufman, C, llstad, S. Facilitating cells enable engrafment
    of purified fetal liver stem cells in allogeneic recipients. Exp Hemat 1996;
7. Goss, J, Flyc. W, Lacy, P. Succesful transfer of immune unresponsiveness to
    concordant rat islet xenografts. Transplantation 1996; 6 1:9-13
8. Goss, J. Nakaflisa, V. Finke, E, et al. Induction of tolerance to islet xenografts
    in a concordant rat-to-mouse model. Diabetes 1994; 43:16-23
9. Aebjscher, P. Lacy, P. Gerasimidj-Vazeoim A, HauptfkI, V. Production of
    marked prolongation of islet xenograft survival (rat to mouse) by local release
    of mouse and rat antilymphocyte sera at transplant site. Diabetes 1991;
10. Gehrling, IC, Serreie, DV. Christianson, SW, Leitcr, Elf. Intrathymic islet cell
       transplantation reduces beta-cell autoimumunity and prevents diabetes in
       NOD/Lt mice. Diabetes 1992; 41:1672-1676
11. Morris, C, Simeonovjc, C, Ming-Chiu, F, et al. Intragraft expression of cytokine
       transcripts during pig proislet xenograft rejection and tolerance in mice. J
       lmmtmnol 1995; 149:2470-2482
12. Satake, M, Korsgren, 0, Ridderstad, A, et al, Immunological characteristics of
       islet cell xenotransplantation in humans and rodents, Immun Rev 1994;
13. Lafferty, KJ, Mao, L. Approaches to the prevention of immune destruction of
      transplanted pancreatic islets. Transplant proc 1994: 26:399-400
14. Gage. F. Ccll therapy, Nature 1998; 392(supp):l8-24
15. Gwinup, G, Elias,AN. Hypothesis: insulin is responsible for the vascular        complications of diabetes. Medical Hypotheses 1991; 34:1-6
16. Wahren, J. Does C-peptide have a physiological role? Diabetologia 1994;
      37(suppl.2):99- 107
17. Sutherland,DRE. Pancreas and islet transplantation: now and then. Transpl       Proc 1996; 28:2131-2133
18. Niehans, P. Introduction to Cellular Therapy. Pageant Books, Inc. New York,       1960
19. Hendrikx, PJ, Martens, A, Hagenheek, A, et al. Horning of fluorescently labeled       murine hematopoietic stem cells. Exp Hematol 1996; 24:129-140
20. Zanjanj. E. Ascensao, J, Tavassoli, M. Liver-derived fetal hematopoietic stem       cells selectively and preferentially home to the fetal bone marrow. Blood       1993: 81:399-404
21. Hardy. C. The homing of hematopoietic stem cells to the bone marrow. Am .1       Mcd Sci 1995; 309:260-266
22. Sigal, S. Brill, S, Fiorino, A, Reid L.The liver as a stem cell and lineage system.       Am J Physiol 1992; 263:139-I48
23. Tafra, L. Dafoc. DC, Berezujak. R. Fetal liver and pancreas transplanted as a       composite improves islet graft function, Transplant Proc 1991: 23:152- 753
24. Dabeva M Seong Gyu H, Vasa SRG et al. Differentiation of pancreatic       progenitor cells into hepatocytes following transplantation into rat liver. Proc
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25. Dafoe, DC Xuegong, Wang Lee LK, et al. Studies of composite grafts of fetal
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      (editor) Pancreatic Islet Cell Regeneration and Growth. Plenum Press, New
      York, 1992.
26. Adams, G, Xuegong, Wang, Lee, LK, et al. Insulin-like growth factor-I
      promotes succesful fetal pancreas transplantation in the intramuscular site.
      Surgery 1994; 116:751-756
27. Eckhoff, D, Sollinger, Hullett, D. Selective enhancement of beta-cell activity
      by preparation of fetal pancreatic proislets and culture with insulin growth
      factor 1. Transplantation 1991; 51: 1161-1165
28. Gittes, G, Galante, P, Hanahan, D, et al. Lineage-specific morphoge-nesis in
      the developing pancreas: role of mesenchymal factors. Development 1996;
29. Dudek, R, Lawrence, I, Hill, R, Johnson, Induction of islet cyto differentiation
      by fetal mesenchyme in adult pancreatic ductal epithelium. Diabetes
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30. Sykes, M, Yong, Z. Yong-Guang, Y, Tolerance induction for
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31. Auchicloss, H. The scientific study of xenografting: l964- I 988. In: Cooper,
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32. Paul, LC. Mechanism of humoral xenograft rejection. In: Cooper DKC, Kemp l:,
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33. Bach, Fl-I, Platt. IL, Cooper. DKC. Accommodation - the role of natural
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34. Moses,RD. Auchincloss, H. Mechanism of’ cellular xenograft rejection. In:
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35. Thomas, FT. Isolated pancreas islet xenografting. In: Coopcr, DKC, Kemp. E,
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36. Lanza, RP, Chick, WL. Introduction, Chapter 40. In: Cooper, DKC, Kemp, E.,
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37. Thomas, FT. Isolated pancreatic islet xenografting. In: Cooper, DKC, Kemp, E,
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38. Latinne, D, Vitiello, D, Sachs, D, Sykes. M. Tolerance to discordant xcnografts.
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39. Platt., JL. A perspective on xenograft rejection and accommodation. Immunol
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40. Chen, H-M, Jovanovic-Peterson, I., Desai. T, Peterson. C. Lessons learned
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41. Bartlett, S. Chin, T, Dirdcn, B. et al. Inclusion of peripancreatic lymph node
      cells prevents recurrent autoimmune destruction of islet trans-plants:
      evidence of donor chimerism, Surgery 1995; 118:392-399
42. Sandbichler, P, Erhart. R, Herbst, P, et al. Simultaneous transplantation of
      hepatocytes mitigates rejection of small bowel allografis in the rat. Transplant
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43. Fuiji, V. Sugawara, 13, Hayashi, K. Sano, S. Neonatal intrathymic splenocyte
      injection yields prolonged xenograft survival. Acta Med Okayama 1998:
44. Sheffield, CD, Hadley, GA, Dirden, BM, Bartlett, TS. Prolonged cardiac
      xenograft survival is induced by intrathymic splenocyte injection. .J Surg Res
      1994; 57:55-59
45. Merino, JF, Nacher, V. Rauell, M, et al, improved outcome of islet
      transplantation in insulin-treated diabetic mice: effects on beta-cell mass and
      function. Diabetologia 1997; 40:1004-1010
46. Beattie, G, Rubin, J, Mally, M, et al. Regulation of proliferation and
      differentiation of human fetal pancreatic islet cells by extracellular matrix,
      hepatocyte growth factor, and cell-cell contact. Diabetes 1996; 45:1223-
47. Montana, E, Bonner-Weir, S, Weir, G. Beta cell mass and growth after
      syngeneic islet cell transplantation in normal and Streptozotocine diabetic
      C57BL/6 mice. J Clin Invest 1993; 91:780-787
48. Vorob’eva, EA. Pokazateli kletochnogo i gumoralnogo immuniteta u bolnych
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49. Smith, DM. Endogenous retrovirus in xenografts. NEJM 1994: 329:142
50. DiGiacomo, R, Hopkins, S. Food animal and poultry retroviruses and human
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51. Mare, CJ. Viral diseases. In: Weisbroth, SH. Flatt, RE, Kraus, AL. Biology of
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52. Eastlund, T. Infectious disease transmission through cell, tissue, and organ
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53. Kalter, SS, Heberling, RL. Xenotransplantation and infectious diseases. Instit
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54. Fox, JG, Lipman, NS. Infections transmitted by large and small laboratory
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55. Chapman. L, Folks. T, Salomon, M, et al. Xenotransplantation and xenogeneic
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56. Dylan, D, Gill, R, Schloot, N, Wegmann, D. Epitope specificity, cyto-kinc
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      isolated from NOD mice. Eur J Immunol 1995; 25:1056-1062
57. Pittman, K, Henretta, T, Mcfadden, T, et al. Prevention of primary non-
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