Autologous transplantation of stem cells that had been cryopreserved in Biohellenika’s accredited labs in a child suffered from cerebral palsy in Hematology Clinic of Duke University.

On 28-7-2009 Professor Joanne Kurtzberg Head of the Hematology Clinic in the Duke University of USA administered with success an autologous stem cell cord blood graft that were cryopreserved in Biohellenika’s labs. The graft was cryopreserved in three cryovials since the beginning of 2006, few months after Biohellenika’s establishment. The vials were sent to the Hematology clinic in one of the special Voyager tank that the company has.  The infusion of the cells was completed successfully in 10 minutes with absolute no side effects from the administration. The whole procedure was running normally, because the preservative DMSO that Biohellenika’s samples have is in very small quantity. Biohellenika with its own method, that was published in Cytotherapy medical journal in 2007, preserves clear population of nucleated cells and removes the red blood cells almost totally, that finally do not have  any function as stem cells.  So the final cryopreserved volume is very small and so the amount of cryoprotectand DMSO. The child 2 hours later left the hospital and next day the USA. This graft is the 20^th sample of Biohellenika up until today that has been administered to a patient and the first that has been administered from a Hematologic clinic of the USA, abroad Greece. One month later the child was able to make small sentences and to communicate with the parents and the sister better. The speech was the first sight of improvement.  Today, four months later, according to the parents this is a very different child, with a lot of improvements in the walk, the strength ant the self-confidence as it is obvious of her willing to participate in group games. This is a new beginning for the family and as they describe is like to turn a page and left behind difficult conditions. They also know that the way will be long, but realizing the improvement of their child every day, are very optimistic. The improvement was noticed also by the therapist who doesn’t know the treatment. We wish a continuous improving of the child’s health and also we congratulate the parents for their decision to cryopreserve the child’s stem cells for a running day. This precaution saves their child’s life.

Hope of life with the rejuvenation of the myocardium with the transplantation of stem cells

Biohellenika, in cooperation with the Cardiosurgery team of AXEPA University Hospital, performed an innovative surgical procedure giving hope of life to a 64 year old that was at the last stage of cardiac failure.

The experienced scientific team of Biohellenika with head Dr. Koliakos, president of Biohellenika and the TAK EIE, supports with fully state of art equipped labs and with the know-how these applications. The abstraction and re-administration was performed during the same surgical procedure, while it is the first time worldwide that a mechanical heart and stem cells were used with the target of the future removal of the mechanical heart as professor Papakonstantinou, head of the cardiosurgical team of AXEPA Hospital stated.

Innovative administration of stem cells in the lungs for chronic obstructive-disease treatment.

Biohellenika in cooperation with the Lung Diseases Clinic of the University Hospital of Alexandroupolis performed for first time in the world an administration of stem cells in a patient with terminal stage of lung obstruction, in two courses. One cell dose was injected intravenously and another directly to the lungs three months later. The stem cells had been extracted from the adipose tissue of the patient and were cryopreserved in liquid nitrogen in Biohellenika’s lab in Athens (TAKEIE). The purpose of this therapy was at first the survival of the patient and secondly the improvement of the respiratory function. Initially the cells were injected to the patient intravenously on 12/7/09 in Athens. A follow up examination of the patient one month later, showed stable condition with sights of moderate improvement. On 8/10/09 Professor Bouros, Director of the Clinic, and his scientific team with the lab support of Biohellenika administered the second dose of stem cells to the patient intratracheal with local anesthesia in a duration of 10 minutes. The procedure took place in Alexandroupolis University Clinic and were present Prof Bouros who administered the cells, the President of Biohellenika  Dr George Koliakos, the President of the AdiStem company Dr Bill Paspaliaris and scientists from the international field. This patient will be included in an international clinical trial in collaboration with the Pittsburgh University.

16/02/2009

A diabetic foot was cured with the use of stem cells, derived from adipose tissue, that have been processed in Biohellenika’s labs.

Biohellenika performed in Thessaloniki the first therapeutic application of stem cells derived from adipose tissue, in a diabetic patient, that was suffered from foot ulcers.  The ulcers despite the therapies that the patient underwent could not heal and so stem cell therapy was considered.  The abstraction of adipose tissue was performed by liposuction of about 100cm³ around the umbilical area, and the tissue immediately arrived to the Biohellenika labs for cell separation.  The stem cells after isolation were administered to the edges of the ulcer with injections at the periphery. The patient was under surveillance. Ten days after the administration the ulcer presented a significant improvement in a degree that never until today had been evident, regardless the general condition of the patient who was under chemotherapy because of a lung cancer. All the previous treatments were failed and because of the healing, now the general condition of the patient is improved and the low fever that every day were tired the patient now is disappeared. The state of the patient from that day continually improves.

The labs of the National Institute of Research (TAK EIE) were certified by ESYD.

23/10/2009

Biohellenika congratulates the staff of the Stem Cell Bank of the National Research Foundation (TAK EIE) for the accreditation  with the certificate numbered: 61802/10/2009 from the National Accreditation System (ESYD).  The labs are accredited for the quality control of the umbilical cord blood that concerns the determination of the number and the viability of the nucleated cells, the number of the hematopoietic stem cells and also for the microbiological tests for the detection of aerobic, anaerobic microbes and fungi.

The labs in the TAK EIE process samples of southern Greece and the islands and comprise collaboration between the National Research Foundation and Biohellenika. Biohellenika is the first company in Greece that acquired accreditation as medical lab in the field of preservation of stem cells according to ISO 15189,2007, as Biohellenika applies with success all quality systems.  Furthermore the company has certification according to ISO 9001:2000 and ISO 14445 for clean rooms, and therefore is ranked as one of the most reliable companies of the field.

Response to articles in the press concerning banking of stem cells in Greece.

1. The possibility today for someone to use his own stem cells throughout the whole course of his/her life is 1:200, Nietfeld et al 2008, Bio Blood Marrow Transl 14 (3), 316-322.  This analogy in 1997 only for patients who suffered from  the hematopoietic  system diseases and for ages under 20 years old was 74:200000.  According to a study of the University of Arizona today one in three patients over 60 may benefit from the new applications of stem cells with his own cells for the therapy of cardiovascular, ophthalmologic, orthopedic, neurologic and endocrine diseases, Harris et al; 2007, Exper Opin Biol Biological Therapy 7 (9), 1311.
2. From 1995 the blood of the umbilical cord has the same therapeutic applications as bone marrow, Jenney et al 1995, Lancet 346 (8980), 921-2, with more however advantages that derive from the young age of these cells.
3. From 2006 according to the announcement of the European Group for Blood and Marrow the blood of the umbilical cord is included in the program of autologous transplantations for the therapy of autoimmune diseases with mentions to juvenile  rheumatoid arthritis, lupus erythematosous and multiple sclerosis, Bone marr trans 2006, 37(5):434-449.  From the Clinic of Hematology at  Papanikolaou Hospital there have been repeatedly published studies in international medical journals for the therapy of multiple sclerosis with the use of stem cells of the patient himself.  These studies were refer to Greek patients and to patients from collaborating European countries.  The results of this therapy according to these studies are encouraging although the cells of the patients are of greater age and suffer from the disease the moment of the receipt, Kimiskidis et sl 2008, Mult Scler 14 (2): 278-83, Fassas et al 2004, J Neurol Sci 15, 223 (1): 53-8, Fassas et al 2003, J Hematother Stem Cells Res 12(6): 701-11.  If the patient had stem cells derived from the umbilical cord blood that he/she should have cryopresreved from the time of his/her birth the results would be better.
4. Until today in Europe there have been performed 25000 transplantations with the use of hematopoietic primary cells.  70% of these transplantations were autologous, the stem cells were derived from the patient himself, and 30% were allogeneic, they were derived from a donor.  In the 70% of these cases the donor within the family, Watt et al 2007, Methods Mol Biol 368: 237-259.
5. The therapy of solid malignant tumors of youth (sarcoma, neuroblastomas, lymphomas) is performed with the use of cells of the child himself.  The yearly frequency of occurrence  of cancer in children is 130 per million, so the probability of a child to present leukemia or cancer until the age of 16 is 1/500 and for 1 in four children a hematopoietic transplantation is required, Smith et al 2002, Principles and Practice of Pediatric Oncology, 4^th edition Philadelphia PA Lippincott.  The probability of use of the graft is doubled, if one conciders the blood relatives that may make use of the graft.
6. Cancer and leukemia are expressed through a series of mutations in cells that eventually result in carcinogenesis.  For the expression of leukemia two continual mutations in the nuclei of hematopoietic stem cells  are required.  The first mutation results in the formation and circulation in the  blood,  the preleukemic clones.  So if the mutation occurs in the first stages of the development of the embryo prior to birth, then also in the umbilical cord blood  preleukemic clones   will circulate.  From 100 cases of children will preleukemic clones eventually only one child will advance to the second mutation and develop leukemia, Mori et al 2002, Proc Natl Acd Sci USA, 99:8242-8247.  The preleukemic clones in the rest of the children are eventually destroyed from the immune system and disappeared from the blood circulation. For older children and adults there is no issue of detection of preleukemic clones because even in the hypothetical case of birth of a child with preleukemic clone a great period of time has passes from birth to the onset of the disease and the autologous transplantation will give the patient the same period of survival without the fear of rejection of an allogeneic, and not completely compatible graft.  The genes that are responsible or coexist with leukemia can be detected with PCR method on the  stem cells and it will lead to the detection of those pathogenic genes and will resolve the problem of the use of the stem cells of the child or not.

In public banking no test is performed for the presence of preleukemic clones in the stem cells of the donor. For the samples that come from unknown donors a test should be performed also for the detection of inherited diseases. If the probability of 1% of a preexisting malignancy in the stem cells of the umbilical cord is considered significant, the public bank would perform the essential tests for the determination of the existence or not of the malignancy in all grafts that it collects.

1. Mesenchymal stem cells from Wharton’s Jelly are collected today only for autologous use and due to their mutual origin with the primary hematopoietic  stem cells any transfer of inheritance or mutation in these, concerns also the messenchimal cells.  So cryopreservation and autologous transplantation of mesenchymal stem cells of the Warton’s Jelly from the public bank sets under dispute its objection for the autologous administration of hematopoietic  stem cells derived from the placenta, in cases of child leukemia.
2. If chemotherapy was the solution for therapy of cancer or leukemia, one of the greater problems in medicine today would be resolved; the therapy of cancer.
3. In 2007 a case of a 3 year old child suffering from acute lymphoblastic leukemia was published. At 2003 chemotherapy failed twice in this child and finally with his own stem cells, that the family had cryopreserved for percussion burring birth in a private bank, Hayani et al 2007, Pediatrics 119, 296-300.  Today 4 years post transplantation the child is free of symptoms. In leukemia the total survival among patients that received their own stem cells or allogeneic compatible grafts don’t differ significantly, Loy Ys et al 2007 Leuk Lymphoma , 48 (1), 72-9.  So what is the problem if the patient posses his own autograft or a graft compatible from a sibling, because the patients had preserved the umbilical cord blood?

10. Lately there have been posed some journalistic opinions that with one small biopsy of the skin one could have stem cells for use in  autologous transplantations.  Today for the       transformation of the cells of the skin into stem cells an alteration in 4 genes must be performed and also a simultaneous entry of 4 different viruses in the cell, with unexpected results. Gene therapy is not safe neither with the use of just one virus.  This kind of therapy was abandoned after the death of children with cystic fibrosis, due to the revival of the virus that had been used for gene therapy. Another reason is that with this way adult cells can be transformed into embryonic with the fear of ignition of tumor genes and the formation of teratomas.

11.  The legal guidelines were published in Greece in March 2008 in the presidential order 26/2008.  Until the full application of the greek legislation the greek private cryobanks must follow the European legislation and must be certified from greek and international bodies as the national system of certification (ESYD)

12. For many years and even today, stem cells of greek families travel to countries abroad.  The foundation of the greek banks and the remain of stem cells in Greece ensures better quality grafts.

13. The uses of stem cells in medicine today refer to all 17 medical specialties and for this reason the validation of the operation of private and public banks the Greek government has assigned the Central Council of Health and not to specific specialties.

President of the Scientific Board of Biohellenika

Dr. Kouzi- Koliakou

 Formation of functional neural tissue

21/02/2009: Jurga M et al Tissue Eng Part A.  2009 Jan 27. Today  the human umbilical cord blood is  an irrefutable source of stem cells that can be transformed  into neural cells.  Using stem cells from the umbilical cord blood the authors of the article formed for the first time neural tissue in biodegradable 3D scaffolds. These 3D structures contrary to the up until today 2D cell cultures formed functional circuits with automatic function.  This study showed for the first time that the use of 3D structures mediates the maintenance of neural stem cells derived from umbilical cord blood stem cells in functional condition. These structures could in the future be useful for the rejuvenation-reconstruction of damaged areas of the brain.