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NEWS 04 September 2008

www.biohellenika.gr

Treatment of Diabetes type I with umbilical cord blood stem cells

05 Treament of tracheaomediastinal fistula using autologous adipose-derived stem cells

06 Stem cells from the placenta

08 Cord blood stem cells. Potential neurological applications

Use of stem cells for the treatments of chronic skin ulcers

10 New services provided by Biohellenika

11

Clinical trials with the use of umbilical cord stem cells for the treatment of benign diseases Today worldwide interest is focused on the results of two phase I/II clinical trials, where umbilical cord stem cells are used. These trials concern the treatment of Type I diabetes and cerebral

palsy. The clinical trial for Type I diabetes is performed at the University of Florida, USA and 23 children with diabetes participate. page 4 n

Adult stem cells from adipose tissue

15

Stem cells from dental pulp A new source of stem cells for the therapy of myocardiac ischemia. Cell therapy with stem cells and endothelial progenitor cells to stimulate angiogenesis, as a potential treatment for myocardiac ischemic disease, in an exciting area of research in regenerative medicine. page 9 n

Stem cells rerived from adipose tissue, a new biological treasure Accroding to the recent scientific bibliography, the adipose-tissue-derived stem cells consist one of the most promising tools of Regenerative Medicine. page 7 n


02

NEWS

Hellenic Accreditation System S.A.

Annex G1/1 to the Certificate No.410

SCOPE of ACCREDITATION of the Laboratory of the BIOHELLENIKA S.A. Materials/Products tested

Applied methods/Techniques used

Types of test/Properties measured

Haematology Tests Umbilical cord blood and nucleated cells from umbilical cord blood

1. Determination of the number of nucleated cells (granulocytes, lymphocytes, monocytes) and of the red blood cell count

Automated cell flow analyzer (COULTER ACT DIFF PAK)

2. Estimation of the viability of nucleated cells and counting of haematopoietic stem cells (CD45+ dim / CD34+)

Flow cytometry-Protocol ISHAGE STEM KIT (BECKMAN-COULTER)

Biohellenika SA is the only Accredited by ESYD (National Accreditation Forum) Stem Cell Cryopreservation Company

Microbiological Tests 1. Test for bacterial infection (aerobic / anaerobic)

Nucleated cells from umbilical cord blood

Fluorescent medium, closed method (BACTEC system)

th

Site of assessment: Permanent laboratory premises, 65 Georgikis Sxolis Avenue, Thessaloniki, Greece.

The Accreditation Certificate No.410,K.toKouzi-Koliakou. ELOT EN ISO 15189:2007, is valid until 7.2.2012. Approved signatories: G. Koliakos. Athens, February 8, 2008

N. Papaioannou Chairman of ESYD

Page 1 of 1

Annex G l/1 to the Certificate ESYD No.410

8.2.2008

Hellenic Accreditation System S.A.

ACCREDITATION CERTIFICATE Áñ. 410 The Hellenic Accreditation System S.A. (ESYD), as the national accreditation body of Greece, in accordance with the Law 3066/2002,

ACCREDITS

the

Laboratory of the

BIOHELLENIKA S.A. in Thessaloniki, Greece

Athens, February 8, 2008 Í. Papaioannou Chairman of ESYD

n When Ltd companies were claiming to be “the only ones operating under the guidelines of ISO 15189”, Biohellenika's scientific team was striving to improve the quality of their services provided. On 21/02/2008 Biohellenika attained the 410 08/02/2008 accreditation by the National Accreditation Forum S.A (ÅÓÕÄ), granted for procedures followed and quality testing of umbilical cord blood during the collection of stem cells. With this certification, Biohellenika is accredited according to ISO 15189:2007, special for medical laboratories, for nucleated cell measurement, haematopoietic stem cell viability and microbial testing, including aerobic, anaerobic bacteria and fungi. This certificate is valid until 2012 as long as the facility's operations comply with the above guidelines during regular ÅSYD inspections. The National Accreditation Forum (ÅSYD) is a full member of the International Laboratory Accreditation Cooperation (ILAC) since 2004, of the European Cooperation for Accreditation – EA since 2005, and of the International Accreditation Forum (IAF-MRA) since 2006. The international identity of ÅSYD gives the perspective of the parity and mutual recognition of accreditation between countries. Today Biohellenika is the first company in Greece whose laboratories are accredited by a national independent organization for measurements and quality control procedures followed during stem cell collection from umbilical cord blood.

NEWS Quarterly publication of Biohellenika

Biohe enika BIOTECHNOLOGY COMPANY

the biggest greek stem cell cryopreservation institution

Nr 04 65, Georgikis Scholis Avenue, 57001 Thessaloniki ZEDA building, 1st floor, entrance 3 Tel.: +30 2310 474282, 2310 474284 , Fax: +30 2310 474285 E-mail: info@biohellenika.gr, www.biohellenika.gr Biohellenika S.A. is responsible for the published material in this issue. All rights reserved. No part of this issue may be reproduced without permission of the publisher.


NEWS 03

New Stem Cell Collection Services Biohellenika, the most established Greek Stem Cell Cryopreservation Company, was founded and operates under the strict surveillance of scientists, Mr. Koliakos, Assoc. Professor of Biochemistry and Mrs. KouziKoliakou, Assoc. Professor of Histology-Embryology. The services which are provided are scientifically proven and came as a result of the long-term experience of the scientists, responsible for academic research and medical practice.

The Advantages of Biohellenika Security: Financial support to the child up to £ 100,000 euros for cancer and leukaemia treatments. Specialized Personnel: The scientific team consists of £ Professors from the Aristotle University of Thessaloniki and specialized scientists with PhD and postgraduate degrees and long-term experience in cell line cryopreservation since 1987. Freedom of choice: Two means of cryopreservation £ (cryobag or cryovials) Preservation Security: Preservation at two separate £ locations, in Athens and in Thessaloniki. Direct Access: Preservation on Greek ground. £ The clean rooms are accredited by ISO 14644-5 and £ equipped with IVD and CE marked reagents and instruments. The labs are strictly designed according to GMP. Certification of Operation: ISO 9001:2000 Certificate £ No 362306 (Lloyd's Register Quality Assurance. Accreditations: Accredited medical quality control £ laboratories, Certificate No 410, 8/2/2008 ESYD. Guarantee: Collaboration with the National Research £ Institute for the unhindered preservation of the stem cells. Exclusive collaborations: in collaboration with the £ National Research Institute, the National Research Institute Stem Cell Bank (TAK-EIE) was established. In addition, Biohellenika has an exclusive collaboration with the biggest private maternity clinic Genesis, EuroMedica company which operates all over Greece, GENDIA labs and Cytori.

Biohellenika, exhausting all the possibilities which are provided by the birth of a child in order to collect the majority of stem cells, is going further than the classic collection of the puncture of the umbilical cord, with two additional means of collection. An increased number of stem cells is necessar for the therapy of patients with large body mass, for whom the classic blood collection may not be enough. COLLECTION OF STEM CELLS BY STRAINING THE PLACENTA The first way of collection concerns the isolation of stem cells that remain inside the placenta after the classic blood collection. For this purpose, the whole placenta is transferred to the laboratory, under specified conditions. A large number of stem cells are trapped in the extended network of placenta vessels and remain there unused. Biohellenika using its own specific published procedure collects all these cells which are added to the initial, classic collection of stem cells. With this method, a two-fold number of stem cells are ensured, stem cells that would otherwise be discarded together with the placenta, without this second collection. STEM CELL COLLECTION FROM THE UMBILICAL CORD BODY (WHARTON'S JELLY) The second way of collection concerns the collection of mesenchymal cells that are found outside and around the umbilical cord vessels, which cannot be collected neither by the classic collection nor by the straining of the placenta. Stem cells originating from Wharton's jelly are obtained after the collection and special treatment of a segment of the umbilical cord. CRYOPRESERVATION OF THE AMNION Biohellenika has the ability to collect and preserve part of the amnion if requested. COLLECTION OF STEM CELLS FROM DECIDUOUS TEETH Biohellenika gives a second chance to children, who have not cryo-preserved their umbilical cord stem cells, to preserve stem cells from their deciduous teeth that are replaced by the permanent teeth from the age of 6 years. Also adults can cryopreserve stem cells from the wisdom teeth or permanent teeth that are extracted for orthopedic purposes. COLLECTION OF STEM CELLS FROM ADULT ADIPOSE TISSUE Biohellenika, a pioneer in the cryo-preservation of stem cells in Greece, gives for the first time, the oportunity to adults to preserve adipose derived stem cells, which are collected either durig a surgical procedure or during liposuction. The opportunity that is given to adults to collect and preserve their adipose derived stem cells for any use in the near or distant future, is provided for the first time in Greece through the collaboration of Biohellenika and the American company Cytori, an international pioneer in therapeutic applications and unique of its kind. This new service is accredited by the American Authorities.


04

NEWS

CLINICAL TRIALS WITH THE USE OF UMBILICAL CORD STEM CELLS FOR THE TREATMENT OF BENIGN DISEASES.

Today worldwide interest is focused on the results of two phase I/II clinical trials, where umbilical cord stem cells are used. These trials concern the treatment of Type I diabetes and cerebral palsy. n The clinical trial for Type I diabetes is performed at

In the second trial, the use of the own child's umbilical

the University of Florida, USA and 23 children with

cord stem cells for the treatment of cerebral palsy or

diabetes participate. This trial is the second in line, as it

brain injury is tested, which is underway at Duke

was based on the results of a previous trial performed at

University, with 12 children born with perinatal asphyxia

the Medical School of the University of Sao Paolo in Brazil

participating. These children received their own stem

and the results were published in the medical journal

cells no sooner than their second year. Preliminary data

JAMA in 2007. In the fist trial stem cells from peripheral

from this study was announced in the 20th Congress of

blood were administered to 15 patients with recent

Umbilical Cord Blood Clinical applications in Mandelieu

diabetes symptoms, after chemotherapy. The patients

France in October 2008. Up to now the results are very

were followed up for 38 months. All the patients showed

promising.

improvement of the quality of life, one was completely cured and free of insulin use during the trial, and the rest were free of insulin for long periods of time. In all patients the levels of insulin were increased and the daily dose was decreased. Voltarelli et al 2007, JAMA 297 (14): 156876. The conclusions of this trial were used for the second trial, where autologous umbilical cord stem cells were administered without prior chemotherapy.


NEWS 05

Treatment of Diabetes type I with umbilical cord blood stem cells up of 10 subjects, with the final report issued after all subjects have reached the two year post infusion. Haller MJ et al, Experimental Hematology 2008, 36(6):710-715

It should be noted that so far from the 50 subjects who could have been included in this study, only 15 accepted to enrol, due to the fact that recent bibliographic data show that the regeneration of the pancreas by the umbilical cord stem cells will soon be possible. Hence, Chinese scientists recently reported that human umbilical cord blood-derived mesenchymal stem cells have the ability to differentiate into insulin-producing islet-like cells and may be a potential new source for islet transplantation. Multiple scientific data indicate that stem cells from n umbilical cord blood consist an ideal means for the treatment of autoimmune diseases such as diabetes type I, lupus erythematosus and rheumatoid arthritis. In order to ensure the safe application of this new potential, doctors of the paediatric department of the University of Florida, USA, administer a simple intravenous infusion of the stem cells that parents had foreseen to cryo-preserve at birth to children suffering from type 1 diabetes, without any previous chemotherapy. To date, 15 autologous infusions have been safely performed, while the study intends to include 23 cases of children in total. In order to materialize this transplantation a recent diagnosis of the disease and the preservation of autologous cord blood stem cells are required. The first encouraging preliminary data from 8 n subjects were reported at the American Diabetes Association Scientific Sessions in June 2007. Scientists expect to formally report data after the one year follow

Gao Et Al Transl Res 2008 Jun; 151:293-302

Furthermore, American scientists reported that human umbilical cord blood cells are capable of differentiating into pancreatic acinar cells. Minamiguchi et al, Pankreas 2008 Mar;36:e30-35

“Considering the fact that the majority of the stem cell banks re-examine the methods of preservation, in order to allow multiple “withdrawals”, new methods to include more than one infusions may be tried in the future” the writers report. Haller MJ et al, Experimental, Hematology 2008, 36(6):710-715


06

NEWS

Treatment of Diabetes type I with infusion of adipose tissue-derived mesenchymal stem cells combined with haematopoietic stem cells Treament of tracheaomediastinal fistula using autologous adipose-derived stem cells n Trachea fistulas that appear as a post-operative complication of respiratory system cancer represent a challenging management problem and the standard treatment in most cases is based on surgical procedures. Various endoscopic methods have been tried on high risk patients with high risk, but the results are often unsatisfactory. Thoracic surgeons from ÂŤLaPazÂť University Hospital in Madrid recently announced that a fistula was treated by bronchoscopic injection of autologous adipose-derived stem cells. Postoperative bronchoscopic examination of the wall and base of the fistula revealed re-epithelialisation and neovascularisation that led to successful closure.

Alvarez et al Thorax 2008 Apr; 63:374-376

n Indian scientists recently reported the treatment of 5 patients who suffered from type I diabetes, by infusion of autologous adipose tissuederived stem cells combined with autologous cells from bone marrow that are proliferated in cell culture. All patients were successfully infused without any adverse effects and showed 30-50% decrease in insulin requirements, while their serum c-peptide levels (an indicator of insulin production) were increased by 4- to 26-fold. Trivedi et al, Transpl Proc 2008 May;40:135-113

These studies come to reinforce the results of a n study published by Brazilian scientists in the Journal of American Medical Association (JAMA) in April 2007, who treated 15 diabetic patients after chemotherapy and administration of autologous haematopoietic stem cells. Voltarelli et al JAMA 2007 Apr 11;297:1568-1576

The significant difference of these newer studies is the nowadays chemotherapy that could be harmful for the patient’s health, is not required.


NEWS 07

Stem cells derived from adipose tissue, a new biological treasure n According to the recent scientific bibliography, the adipose-tissue-derived stem cells consist one of the most promising tools of Regenerative Medicine. Recent publications report that in the Plastic Surgery Clinic in Tokyo University, these cells were used safely and successfully in patients for the treatment of facial lipoatrophy1. The Institute of stem cell research in Korea announced a pilot study according to which, the adipose-derived stem cells can treat skin aging, and the safe application of the method on one patient2. The orthopaedic clinic of Amsterdam University has recently published a review article related to the use of adipose stem cells for intervertrebal disk regeneration3. Scientists from Tokyo University in collaboration with the department of Dental and Oral Surgery of the Military Hospital Yokosuka in Japan announced that adipose derived stem cells may enhance the regeneration of periodontal tissue4. Japanese scientists from Kiusu University announced that the adipose-derived stem cells can be converted into gland cells which produce adrenal steroid hormones5. Another scientific team from the same country announced that these cells transformed to hepatocytes, which were implanted into nude mice with liver damage6, while german scientists from Halle Wittenberg University had announced the same observation first, just three months beforehand7. Finally, Italian scientists from the GB Rossi polyclinic in Verona announced for the first time that the adipose-derived stem cells also have the potential to differentiate into neural cells8.

1. Yoshimura et al Dermatol Surg 2008 May 28 [Epub ahead of print] 2. Park et al Dermatol Surg 2008 Jun 27 [Epub ahead of print] 3. Hoogendoorn et al J Cell Mol Med 2008 Feb 24 [Epub ahead of print] 4. Tobita et al Tissue Eng Part A 2008 Jun; 14: 945-953 5. Gondo et al Endocrinology 2008 Jun 19 [Epub ahead of print] 6. Banas et al J Gastroenterol Hepatol 2008 Jun 25 [Epub ahead of print] 7. Stock et al Tranplant Proc 2008 Mar;40:620-623 8. Anghileri et al Stem Cells dev 2008 Jun 18 [Epub ahead of print]


08

NEWS

Stem cells from the placenta Placental mesenchymal stem cells treat a patient suffering from dilated cardiomyopathy n For the first time American scientists announced

Great scientific interest for the placental stem cells n Placenta tissue draws great interest as a source of

cells for regenerative medicine, because of the plasticity of many of the cell types isolated from this tissue. Furthermore, placenta stem cells have been found to display immunomodulatory properties thus proving valuable for the transplantation of not completely compatible transplants. Thanks to these two unique features, the placenta could prove useful for future therapy-based clinical applications. Numerous reports describing stem cells from different parts of the placenta using isolation and characterization procedures have been published. The conclusion of the scientists is that the placenta is a useful future tool for the treatment of a large number of diseases. Biohellenika taking research studies into consideration, offers the collection of these stem cells to parents, using a unique technique that has been published in international congresses and the journal, Transplantation Proceedings 39, 3380-3384,2007. Ornella Parolini et al., Stem Cells, 2008 :26 ;300-311

the therapy of a patient with dilated cardiomyopathy with the use of allogeneic stromal mesenchymal stem cells from the placenta and autologous haemopoietic stem cells from his peripheral blood. The therapy was considered to be safe and was based on the results of phase I and II clinical studies, related to the use of stem cells for the therapy of cardiac damage after heart attack. The up-to-date experience for the therapy of cardiac damage was based on the use of bone marrow stem cells, which are predicted to be replaced, due mainly to the fact that they are aged cells, they do not have the ability to multiply and furthermore, their procurement is painful.

Pre-clinical studies with the use of mesenchymal umbilical cord blood stem cells have shown that they: ? Inhibit myocardial inflammation ? Inhibit cardiomyocyte apoptosis ? Stimulate angiogenesis ? Display therapeutic activity in experimental models of dilated cardiomyopathy

Échim TÅ et al. Reprod Biomed Online 2008, 16(6):898-905


NEWS 09

Stem cells from dental pulp STEM CELLS FROM DENTAL PULP. A NEW SOURCE OF STEM CELLS FOR THE THERAPY OF MYOCARDIAC ISCHEMIA

STEM CELLS FROM THE DENTAL PULP OF A WISDOM TOOTH CAN PRODUCE SPERM CELLS IN INFERTILE MAN

Cell therapy with stem cells and endothelial progenitor cells to stimulate angiogenesis, as a potential treatment for myocardiac ischemic disease, in an exciting area of research in regenerative medicine. The progenitor endothelial cells are found in the bone marrow, peripheral blood and in adipose tissue. Japanese scientists announced recently that they isolated, for the first time, progenitor endothelial cells from the pulp of teeth. These cells showed a great ability of proliferation, migration and multilineage differentiation. In experimental models these cells resulted in significant therapeutic action. The cells derived from dental pulp represent a new source of stem cells useful for cell therapy for the stimulation of angiogenesis during tissue regeneration, conclude the writers.

Dental pulp stem cells from the wisdom tooth of an infertile man were injected into the testes of experimental animals. An examination of the testes showed that the stem cells from the pulp were vital for a long time and a lot of them transformed to progenitors of sperm. These results show that human dental pulp stem cells injected into experimental animals can be transformed into progenitors of sperm. A 10-15% of men who face a fertility problem in the future could be helped according to this data. These results were announced in Barcelona, Spain in June 2008 at the annual conference of the European Society of Human Reproduction and Embryology from Irina Kerkis, who works at the Roger Abdelmassih research centre of Sao Paolo, Brazil.

Iohara et al Stem Cells 2008 Jun 2008 [Epub ahead of print]

NEW EXPERIMENTAL DATA ARE CONTINUOUSLY ARISING FROM THE USE OF DENTAL PULP STEM CELLS Scientists from Brazil used stem cells from dental pulp to reconstruct cranial bone defects on experimental animals. Cells were used after culture and in vitro characterization as mesenchymal cells. Bone formation was observed one month after the surgical implantation of the cells at the area of the bone defect. This observation constitutes dental pulp as a valuable material for the treatment of bone defects. DE Mendonca Costa A et al., J Craniofac Surg 2008;19(1):204-210

MUSCULAR DYSTROPHY OF DUCHENNE The muscular dystrophy of Duchenne is the most common hereditary disease of the neuromuscular system. At the age of 10-12 years the patients end up with permanent disability and die from cardiac and respiratory problems. Scientists from Brazil used stem cells from dental pulp for the treatment of experimental animals with muscular dystrophy of Duchenne. The dental pulp contains mesenchymal stem cells, which actually have greater multiplication capability than cells from bone marrow. After the transplantation, dental pulp stem cells were traced in the muscles of the experimental animals, while the one that received the biggest quantity of the stem cells expressed human muscular dystrophine, the mutation of which is responsible for the clinical image of the disease. The experimental animal was free of symptoms 25 months after treatment. The systematic and repeated injections of stem cells seemed more effective than one single local injection. Kerkis I et al 2008 J Transl Med Jul 3;6(1):35. [Epub ahead of print]


10

NEWS

Cord blood stem cells Potential neurological applications different types of stem cells in numbers not seen in any other location, including embryonic-like stem cells, haematopoietic cells, endothelial stem cells, epithelial stem cells, mesenchymal stem cells and unrestricted somatic stem cells. Haris DT Stem Cell Rev. Aug 5 2008 [Epub ahead of print]

n It is estimated that as many as 128 million individuals in USA (almost 1/3 of the population), might benefit from regenerative medicine, as reported in a recent review by Professor David Harris at Arizona University. Many of these individuals suffer from diseases that affect the nervous system, which were considered to be incurable such as e.g. patients with cerebral attack (700.000 new patients annually at a cost of more than 65 billion $). The course of regenerative medicine today seems to depend on non-embyonic stem cell therapies. Non-embryonic stem cells can be collected in significant quantities from the umbilical cord blood, adipose tissue and bone marrow. Cord blood stem cells seem to be the best alternative, as these cells can be transformed into any other cell of the organism. The umbilical cord blood contains a mixture of

Scientists from the Neurological Clinic of North Florida University, USA, published recently a detailed method for the production of neurons from mesenchymal cells derived from umbilical cord blood stem cells. Song et al Methods Mol Biol 2008; 438:123-134)

Similarly, scientists from Heinrich Heine University of Dusseldorf announced for the first time the differentiation of the pluripotent somatic stem cells from the umbilical cord blood, into dopaminergic neurons useful for the treatment of Parkison’s disease. Greschat et al Stem Cells Dev 2008 Apr;17:221-232

Use of stem cells for the treatments of chronic skin ulcers n Scientists from the USA used stem cells from the bone marrow of patients with chronic diseases, for the treatment of chronic skin ulcers which had appeared as a result of their disease. The patients who had treatment with stem cells either directly or after cell culture, suffered from scleroderma, diabetes, paraplegia or obstructive angiopathy. Three weeks after the treatment all the patients showed erythema and small vessels at the area of the chronic ulcers. At the same time, there was an activation of all the growth factors in the area of the ulcer and creation of

new skin tissue. Use of stem cells for the treatment of chronic skin ulcers is a very promising method for patients who are in danger of losing their extremities. Evangelos V. Badiavas et al., Wound Repair and Regeneration 2007; 15:856-865


NEWS 11

NEW SERVICES PROVIDED BY BIOHELLENIKA COLLECTION OF A DOUBLE QUANTITY OF BLOOD RICH IN NUCLEATED AND MESENCHYMAL STEM CELLS FROM THE PLACENTA n After birth, a large number of stem cells is trapped in the extended net of placenta vessels and remains there, unexploited. The scientific interest as well as the company's effort for services improvement, led to the application of the leading technique for the collection of the stem cells that remain in the placenta vessels, after the classic blood collection.

The additional number of stem cells that is collected by this method, is adequate for the treatment of adult patients with large body mass and possibly for new therapeutic applications. In Biohellenika the additional stem cells collected from the placenta are preserved separately so a second medical result is given to the parents, similar to the one of the umbilical cord blood stem cells. It is noted that the scientific team of Biohellenika was awarded at the 15th Panhellenic Congress of Transplantations 2007, for this new procedure, concerning the stem cell collection from the placenta. The publication of this method caused world-wide interest, as in February 2008 it was announced as the most interesting medical study with practical results, on the internet for 1 week.

STEM CELL COLLECTION FROM THE UMBILICAL CORD (WHARTON'S JELLY) Mesenchymal cells are found outside and around the n umbilical cord vessels. The collection of these particular stem cells is done with the collection of a part of the umbilical cord and a special procedure of separation of the cells in the lab. The collection and cryopreservation of these mesenchymal stem cells offers an additional number of cells useful for regenerative medicine. For the collection of the stem cells from the body of the umbilical cord the parents must receive a special sterilized vial and the collection bag for the blood, which

are given to the doctor as he enters the delivery room. After the classic collection, the doctor cuts a segment of the umbilical cord (approximately 15 cm) and places into the vial. After all the necessary examinations the parents will receive an additional medical result that describes the number and the viability of the Wharton’s jelly mesenchymal cells.

NEW TECHNOLOGY FOR THE VIROLOGY CONTROLS For an even better service to the parents and the n timely completion of the quality control that concerns the tracing of viruses, Biohellenika’s laboratories are equipped with the most reliable, automatic PCR system of “Roche”, COBAS S 201. This system is used nowadays only by known public blood donation centers, according to the European Union's recommendations, because of the major security provided for the tracing of viruses. The results of the virology tests are given on the same day, so it is not necessary for the mother to provide her virology tests. This technology offers direct tracing of viruses in the child's blood and frees the mother from repeated tests, which can only indirectly prove the existence of viruses in the child's blood. This procedure obtains special value and is extremely necessary for mother who are virus carriers, who are directly informed whether the virus has passed to the newborn or not and can regulate treatment accordingly.


12

NEWS

THE COST OF WELFARE BANKING FOR

scientists concluded that the mesenchymal cells present

EVERY YEAR OF A PATIENT'S SURVIVAL IS

immunosuppresive activity only in autologous use.

ESTIMATED BETWEEN 44.000$ TO 153.000$

Mesenchymal stem cells are also found in significant quantities around the vessels of the cord, in Wharton's Jelly, and in the stroma of the placenta.

The administration of cryo-preserved umbilical cord n

Prigozhina et al Exp. Hematol. 2008 Jul 9

stem cells is an acceptable alternative for bone marrow

[Epub ahead of print].

transplantation. Scientists from the Department of Health Policy and Management of the School of Public Health of Atlanta (USA) estimated the cost of welfare banking per year of a patient’s life who survives after allogeneic transplantation. They calculated the

THE LOSS OF INTEGRITY OF THE

possibility of tracing a compatible transplant and then

CRYOPRESERVATION BAGS SEEMS TO HAVE

calculated the survival time of the patients who receive

NO IMPORTANT SIDE-EFFECTS

transplants derived from non relative donors (allografts). The cost was calculated at 44.000$ per year of survival when the “bank” preserves 50.000 units and reaches 153.000$ when the “bank” preserves 150.000 units.

Scientists in the field of laboratory medicine and n Biopathology of the Medicine School of University of Minnesota (USA), studied the integrity of the cryopreservation bags that were thawed for the

Howard et al Med Decis Making 2008 Mar-Apr;(2):243-53

transplantation at the welfare “bank” of the institute, between January and May 2006. At the same time they recorded the results of transplantations receiving a broken umbilical cord blood unit, in the cases that the

MESECHYMAL CELLS PROTECT ONLY IN AUTOLOGOUS USE

doctors decided to proceed with the transplantation. The results showed that a percentage of 3.5%-9.6% of the bags appeared to have cracked points after thawing. The majority of cases (75%) of loss of container integrity

Scientists from the department of Bone Marrow n

occurred in units that had been cryo-preserved for more

Transplantation of Hadassah University Hospital in

than 2 years. Apart from the increased dosage of

Jerusalem report that stromal mesechymal cells not only

antibiotics, no adverse effect was noted in cases that

can be useful for regenerative medicine therapies, but

received a broken umbilical cord blood unit. The

they are also imunosuppressive and prevent activation

conclusion is that there was a relatively low incidence of

of allogeneic lymphocytes experimentally in in-vitro

umbilical cord blood bag breaks and the adverse effects

conditions. For this reason, it is possible that these cells

are manageable. With the FDA considering licensing of

protect the graft recipient from the severe and often

UCB for hematopoietic reconstitution, improvement in

lethal graft-versus-host disease. In order to control this

container design and possibly guidelines limiting length

disease even more, the scientists used a murine model of

of storage will likely be addressed in detail.

gra f t-ve r s u s - h o s t d i s e a s e, by i nt rave n o u s l y transplanting parental or recipient mesenchymal stem

Thyagarajan et al, Transfusion 2008 Apr 16

cells together with parental lymphocytes. The Israeli

[Epub ahead of print].


NEWS 13

Preservation and Safety at the Maternity Clinic “Genesis” Biohe enika ÅÔÁÉÑÅÉÁ ÂÉÏÔÅ×ÍÏËÏÃÉÁÓ

n The successful cooperation between Biohellenika

and private maternity clinic “Genesis” of Thessaloniki continues. The program Care and Safety offers today to the parents who choose to have their child at the maternity clinic “Genesis”, the most complete umbilical cord stem cells cryo-preservation service. The parents who choose to give labor at the clinic it is not necessary to carry the collection bag, among their other things during entry. The clinic will ensure it is

provided at the delivery room. Upon entry of the

Group Insurance for Biohellenika's Children

parents in the Maternity Clinic they express their wish to collect stem cells and the clinic in collaboration with Biohellenika ensures that the stem cell collection

n The special care and safety of Biohellenika is

procedure is completed without an added burden to

reinforced by the cover of hospitalization fees up to

the parents.

the amount of 50.000€ in case of using the stem cells

The Maternity Clinic Genesis guarantees the

for the treatment of cancer or leukemia in Greece or

preservation for the next 20 years as described in a

abroad for the duration of the Private Contract.

special article in the Private Contract.

Furthermore, in the rare case of an unsuccessful

transplantation, for any reason, Biohellenika will continue the effort for treatment and search of a new compatible transplant. For this purpose Biohellenika will contribute up to 100.000€. The provisions above are contained in special articles of the Private Contract.


NEWS 15

ADULT STEM CELLS FROM ADIPOSE TISSUE Biohellenika in collaboration with the American Company Cytori (www.cytoritx.com) provides the Greek population with the potential of the certified collection and storage of mesenchymal adipose-derived stem cells. n Adipose tissue is a rich source of stem cells which can easily be collected, without complications and in a large number, during the plastic surgery of liposuction1. “The mesenchymal stem cells are currently in focus because of their clinical potential in cell therapy and tissue engineering”. These are reported by scientists from Heidelberg University, who compared the specifications of mesenchymal stem cells derived from umbilical cord blood, from liposuction material, and form bone marrow. “Even though bone marrow represents the main source for mesenchymal stem cells for experimental and clinical studies, its clinical value is diminished as both the number of the stem cells and their differentiation capacity decline with age” scientists report ?.

“Cell therapy holds great promise and is increasingly used to improve prognoses in cardiac disease. Recently, it has been shown that adipose tissue contains pluripotent cell types with remarkable plasticity and the

ability to undergo multilineage differentiation” scientists from the Erasmus University of Holland report2. “Studies on experimental animals, showed a significant improvement on the left ventricle function without reporting potential mortal arrhythmia. The first clinical study (on patients), the APOLLO study, has already started and will study the safety and transplantation potential of these cells in patients with severe cardiac ischemia”, announced the Dutch scientists². 1. Bieback et al Biomed Mater Eng 2008;18 (1 Suppl):S71-76.

2. Meliga et al Cell Transplant 2007;16(9):963-970.


Biohe enika BIOTECHNOLOGY COMPANY

the biggest greek stem cell cryopreservation institution

clinical trials Accreditation Number 410

1

THESSALONIKI Laboratories - Offices 65, Georgikis Scholis Avenue, 57001 Thessaloniki, ZEDA building Tel.: 0030 2310.474.282, 2310.474.284, Fax: 0030 2310.474.285 E-mail: info@biohellenika.gr, www.biohellenika.gr Offices: 137 Tsimiski Str., 6th floor Tel.: 0030 2310.274.286, Fax: 0030 2310.274.288 Mobile: 0030 6944.677.746

ATHENS Offices 2 Mesogion Str, Athens Tower, Building B, 2nd floor Tel.: 0030 210.77.08.882, 210.77.08.218, Fax: 0030 210.77.90.788 Mobile: 0030 6974.039.621, email: info@biollenikasa.gr Laboratories NATIONAL INSTITUTE OF RESEARCH 48 Vasileos Konstantinou Str. 11635 Athens Ôel.: 0030 210.72.73.700, Fax: 0030 210.72.46.618 TAK.EIE 28A Archelaou Str., 11635 Athens Tel.: 0030 210 7299140, Fax: 0030 210.72.99.140

LARISSA Offices 3 Megalou Alexandrou Str. 6th floor, 41222 Tel.: 0030 2410 535603 Mobile: 6973 984260

PATRA Offices Kos 18 & Panepistimiou 3 Tel.: 2610 437436, 6978 483170 Mobile: 0030 6978.483.170

IOANNINA Offices Technological Park, Pedini Ôel.: 0030 26510.97.667, Fax: 0030 26510.97.673 Mobile: 0030 6970.267.540

IRAKLION, CRETE Offices 17 Amaltheias & Katechaki Str. Ôel.: 0030 2810.229.351 Mobile: 0030 6970.803.497

17th November Str., Pilea MB 16513, PC 54301,Thessaloniki Tel.: 0030 2310.984.000, Fax: 0030 2310.984.469 E-mail: info@genesis.org.gr

OPEN LINE________801.11. 99299 (Calls only from line phone)

www.biohellenika.gr • email: info@biollenika.gr Scientific Consultants: K. Kouzi, MD Associate Professor Histology – Embryology, AUTh, Cell phone: +30 6944 677746 G. Koliakos, MD Associate Professor of Biochemistry, AUTh


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