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:
1) ORGANOSPECIFICITY
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.
2) HOMING PRINCIPLE
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.
6) UNIQUE PROPERTIES OF PRECURSOR CELLS
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
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| Adult Rabbit | Adult Human | |
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| Rabbit Fetus | Human fetus | |
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| Native Precursor Xenotransplantation | Cell Stained Precursor Cell | |
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| Adult Rabbit | Adult Human | |
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| Rabbit Fetus | Human fetus | |
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| 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.
PSCT select rabbits (and veterinarians would know why) as the perfect animal source of Precursor Stem Cells based on the followings:
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:
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islets or in vivo treatment with L3T4 antibody produces a marked prolongation
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Sc USA I 987;
84:8080-8084
2. Falqui, L, Finke. E.Caret, J-C.et al. Marked prolongation of human islet
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3. Goss, J, Flake, E, Flyc, W, Lacy, P. Induction of immune unrespon-siveness to
concordant islet xenografts by intraheparic preimmunization and transient
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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;
116:229-235
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;
24:902-913
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;
40:482-485
10. Gehrling, IC, Serreie, DV. Christianson, SW, Leitcr, Elf. Intrathymic islet cell
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