βλαστοκύτταρα biohellenika
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Biohellenika Company Profile

Biohellenika - Biohellenika Company Profile

Biohellenika - Group of companies

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 Biohellenika group of companies

Biohellenika, a group of companies,  includes Biohellenika Biotechnology Company S.A. (founded at 2006 in Thessaloniki), Biohellenika Biotechnology Applications S.A (2007 Athens), BioStem FYROM (2013), Stem Cells Bank of Armenia (2012), and Biohellenika Bulgaria (2012).  

Biohellenika affiliated companies include today Biohellenika Cyprus,  BeoStem (Serbia) and Bioitaly (Italy).    

Biohellenika has developed its own proprietary technology-know-how, turn-key system for stem cell banking that includes stem cell banking from the umbilical cord blood, Wharton’s jelly, placenta perfusion upon birth, dental pulp and ligaments from deciduous and wisdom tooth, bone marrow and adipose tissue, chondrocytes, fibroblasts and PRP (Platelet Reach Plasma).  

Biohellenika’s scientific collaborations include today: National Research Foundation,  National Center for Research & Technology Hellas (CERTH), Aristotle University of Thessaloniki (AUTh), University of Athens, Athens Academy Foundation for Medical and Biological Research (AAFMBR), Democritus University Alexandropolis, MDC research institute Berlin in Germany and Mashhad University in IRAN.

R&D funded projects under development include:

1. Development of new strategies for myocardial  regeneration.

Action: "SYNERGASIA 2009" Funding: General Secretariat for Research and Technology. 

2. Nanotechnology for cartilage   regeneration  for combating osteoarthritis.

Action: "SYNERGASIA 2009" Funding: General Secretariat for Research and Technology. 

3. Antioxidant and anti-aging products from stem cells.

Action: "SYNERGASIA 2011" Funding: General Secretariat for Research and Technology. 

4. Genetic modification of adipose tissue mesenchymal stem cells for combating cancer.  The   use of “sleeping beauty” Transposon for developing of human cell lines capable of producing therapeutic proteins. Action: New business support for research and technological development.   Funding: General Secretariat for Research and Technology 

5. Wound healing (Masha University, Plastic Surgery Clinics  Medical School AUTh and Kapodestrian University Athens).

6. Use of stem cell therapy for the treatment of idiopathic pulmonary fibrosis (Pulmonology Clinic Democritus University Alexandropolis

Biohellenika’s patent portfolio today includes

1.       Patent Diploma Number 1007478 with all the legal attached relevant documents certified: KOLIAKOS GEORGE Biohellenika, Georgikis Scholis 65, 57001, Thermi (Thessaloniki)

Title: Method of stem cells collection from the rich in hematopoietic and mesenchymal cells placenta blood.

2.       Patent Diploma Number 1007483 with all the legal attached relevant documents certified: KOLIAKOS GEORGE Biohellenika, Georgikis Scholis 65, 57001, Thermi (Thessaloniki)

Title: System of preservation of biological samples in cryovials integrally attached.

3.       Patent Diploma Number 1007490 with all the legal attached relevant documents certified: KOLIAKOS GEORGE Biohellenika, Georgikis Scholis 65, 57001, Thermi (Thessaloniki)

Title: Method of mesenchymal stem cell isolation from the total length of the umbilical cord.

4.       Patent Diploma Number 1005560 with all the legal attached relevant documents certified: KOLIAKOS GEORGE,  DARYOUSH HAMIDI-ALAMDARI Biohellenika, Georgikis Scholis 65, 57001, Thermi (Thessaloniki).

Title: Measurment of oxidant-antioxidant balance in fluids.

5.       Patent Diploma Number 1007477 with all the legal attached relevant documents certified: KOLIAKOS GEORGE, DARYOUSH HAMIDI, MOZAFARI  MOSANEN Biohellenika, Georgikis Scholis 65, 57001, Thermi (Thessaloniki).

Title: Measurment of oxidant-antioxidant balance in fluids.

PUBLICATIONS

1.                   N. Tsagias, K. Kouzi-Koliakos, V. Karagiannis, D.H. Alamdari, G.Koliakos  Time and temperature before processing influence the recovery of umbilical cord blood hematopoietic progenitors. Transfusion. 2007 Aug;47(8):1550-2.

 

2.                   G. Koliakos, D. Alamdari, N. Tsagias, K. Kouzi-Koliakos, E. Michaloudi, V. Karagiannis  A novel high-yield volume-reduction method for the cryopreservation of UC blood units. Cytotherapy. 2007 Oct 4;:1-6

3. Transplant Proc. 2009 Dec;41(10):4340-4. doi: 10.1016/j.transproceed.2009.09.053 Addition of adipose-derived stem cells in cord blood cultures stimulates their pluripotent differentiation.Tsagias N1, Kouzi-Koliakos K, Koliakos I, Kostidou E, Karagiannis V, Daniilidis A, Koliakos G.

4. Mesenchymal cells isolation from Wharton’s jelly, in perspective to clinical applications Iro Koliakos, Nikos Tsagias and Vassilis Karagiannis. J Biol Res 16:194-201, 2011.

5. N.Tsagias, Iro Koliakos, M. Lappa, V. Karagiannis, and G. G. Koliakos.

 Placenta perfusion has hematopoietic and mesenchymal progenitor stem cell potential.

Transfusion 2011. Ω 51, p: 976.

6. Anastasiadis K, Antonitsis P, Argiriadou H, Koliakos G, Doumas A, Khayat A, Papakonstantinou C, Westaby S.Hybrid approach of ventricular assist device and autologous bone marrow stem cells implantation in end-stage ischemic heart failure enhances myocardial reperfusion. J Transl Med. 2011 Jan 19;9:12

7. N. Tsagias, I. Koliakos, V. Karagiannis, M. Eleftheriadou, G.G. Koliakos. Isolation of mesenchymal stem cells using the total length of umbilical cord for transplantation purposes.Transfusion Medicine 2011 Aug;21(4):253-61.

8. H. Ravari, D. Hamidi-Almadari, M. Salimifar, S. Bonakdaran, MR. Parizadeh, G.Koliakos Treatment of no-healing woods with autologous bone marrow cells, platelets, fibrin glue and collagen matrix. Cytotherapy. 2011 Jul;13(6):705-11.

9. Tzouvelekis, G. Koliakos, P. Ntolios, I. Baira, E. Bouros, A. Oikonomou, A. Zissimopoulos, G. Kolios, D. Kakagia, V. Paspaliaris, I. Kotsianidis, M. Froudarakis, D. Bouros Stem cell therapy for idiopathic pulmonary fibrosis: A protocol proposal. J of Translational Medicine 2011: 9;182. J Transl Med. 2011 Oct 21;9:182.

10.S. Petrakis, Tamas Raskó 2, Lajos Mátés 3, Zoltan Ivics 4, Zsuzsanna Izsvák Kokkona Kouzi-Koliakou 1, 5 and George Koliakos. Genetic modification of human embryonic kidney and adipose-derived stromal cells using a Gateway compatible transposon vector. Biotechnology Journal 2012 Jul;7(7):891-7. 

11. Hippokratia. 2012 Oct;16(4):366-70. Intramyocardial implantation of autologous bone marrow-derived stem cells combined with coronary artery bypass grafting in patients with ischemic cardiomyopathy: a pilot study. Antonitsis P1, Anastasiadis K, Koliakos G, Vaitsopoulou C, Kouzi-Koliakou K, Doumas A, Argiriadou H, Tossios P.

12. K. Kodonas, C. Gogos, S. Papadimitriou, K. Kouzi-Koliakou, D.Tziafas.  Experimental Formation of Dentin-like Structure in the Root Canal Implant Model Using Cryopreserved Swine Dental Pulp Progenitor Cells. J Endod. 2012 Jul;38(7):913-9. Epub 2012 Mar 28.

13. K. Anastasiadis, P. Antonitsis, A. Doumas, G. Koliakos, H. Argiriadou, C. Vaitsopoulou, P. Tossios, C. Papakonstantinou, S. Westaby  Stem cell transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Inter J Cardiology 2012 Mar 22;155(3):e51-3.

14.  V. Karathanasis,  S.Petrakis,  K.Topouridou,  E. Koliakou, G.  Koliakos , E. Demiri D. Intradermal injection of GFP-producing adipose stromal cellSpromotes survival of random-pattern skin flaps in  rats. DOI 10.1007/s00238-013-0810-y, 2013

 15.   J Transl Med. 2013 Jul 15;11:171. doi: 10.1186/1479-5876-11-171. A prospective, non-randomized, no placebo-controlled, phase Ib clinical trial to study the         safety of the adipose derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis. Tzouvelekis A, Paspaliaris V, Koliakos G, Ntolios P, Bouros E, Oikonomou A, Zissimopoulos A, Boussios N, Dardzinski B, Gritzalis D,Antoniadis A, Froudarakis M, Kolios G, Bouros D.

16. Iran Red Crescent Med J. 2013 Mar;15(3):256-9. doi: 10.5812/ircmj.7975. Lateral Traumatic Esophago-Cutaneous fistula in a Child; Platelet-Rich Fibrin Glue Challenge. Joudi M, Hamidi Alamdari D, Hyradfar M, Rahimi HR, Saremi E, Fathi M, Shojaeian R, Koliakos G.

 17. Cell Tissue Bank. 2014, 15(3):491-9.  A simple method for the quantitation of the stem cells derived from human     exfoliated deciduous teeth using a luminescent cell viability assay.
Tsagias N, Koliakos KK, Spyridopoulos T, Pitiakoudis M, Koliakos E, Korpeti I, Koliakos G.

 18. Histol Histopathol. 2015 Mar;30(3):373-82. Epub 2014 Nov 3.Pluripotent stem cells isolated from umbilical cord form embryonic like bodies in a mesenchymal layer culture.Tsagias N, Kouzi-Koliakos K, Karagiannis V, Tsikouras P, Koliakos GG

19. Regenerated Nerve Defects with a Nerve Conduit Containing Dental Pulp Stem Cells in Pigs: An Immunohistochemical and Electrophysiological Evaluation. Spyridopoulos T, Lambropoulou M, Pagonopoulou O, Birbilis T, Tsaroucha AK, Kouzi-Koliakou K, Botaitis S, Deftereou TE, Gaitanidis A, Pitiakoudis M.

J Reconstr Microsurg. 2015 Sep;31(7):516-26. doi: 10.1055/s-0035-1555751. Epub 2015 Jun 30.

20. Front Neurosci. 2015 Jul 14;9:247. doi: 10.3389/fnins.2015.00247. eCollection 2015. Stem cell models of polyglutamine diseases and their use in cell-based therapies. Siska EK1, Koliakos G2, Petrakis S1.See comment in PubMed Commons below

21. Graefes Arch Clin Exp Ophthalmol. 2015 Jul;253(7):1121-35. doi: 10.1007/s00417-015-3042-y. Epub 2015 May 23.Mesenchymal stem cells improve healing of the cornea after alkali injury. Almaliotis D, Koliakos G, Papakonstantinou E, Komnenou A, Thomas A, Petrakis S, Nakos I, Gounari E, Karampatakis V. 1Laboratory of Experimental Ophthalmology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece, This email address is being protected from spambots. You need JavaScript enabled to view it.

22. Gene Ther. 2014 Feb;21(2):158-67. doi: 10.1038/gt.2013.68. Epub 2013 Nov 28. Intratumoral gene therapy versus intravenous gene therapy for distant metastasis control with 2-diethylaminoethyl-dextran methyl methacrylate copolymer non-viral vector-p53. Baliaka A, Zarogoulidis P, Domvri K, Hohenforst-Schmidt W, Sakkas A, Huang H, Le Pivert P, Koliakos G, Koliakou E, Kouzi-Koliakos K, Tsakiridis K, Chioti A, Siotou E, Cheva A, Zarogoulidis K3, Sakkas L.

23. Diagn Pathol. 2014 Nov 14;9:195. doi: 10.1186/s13000-014-0195-7. A gene therapy induced emphysema model and the protective role of stem cells.

Zarogoulidis P, Hohenforst-Schmidt W2, Huang H, Sahpatzidou D, Freitag L, Sakkas L, Rapti A, Kioumis I, Pitsiou G, Kouzi-Koliakos K, Papamichail A, Papaiwannou A, Tsiouda T, Tsakiridis K, Porpodis K, Lampaki S, Organtzis J, Gschwendtner A, Zarogoulidis K.

24. J of Neurorestoratology 2015:3, 115-120. Treatment with adipose stem cells a patient with moderate Alzheimer’s disease: a case report. Tslaki M, Zygouris, Tsoutsikas, Doxakis, Koliakos G.

25. Hellenic Vet Med Soc 2015, 66 (4): 215-222 Clinical application of adipose-derived stromal vascular fraction in 3 Thoroughbred horses with superficial digital flexor tendonitis: Case Report. Tyrnenopoulou P. , Diakakis N. , Angelopoulou S. , Pyrros A. , Mparous E. , Koliakos G. and Karayannopoulou M.

26. Rejuvenation Res. 2016 Apr 22. Stem cells and aging. Koliakos G.

27. World J Stem Cell. 2016, 26;8(3):101-5. Review. Role of adipose-derived stromal cells in pedicle skin flap survival in experimental animal models. Foroglou P, Karathanasis V, Demiri E, Koliakos G, Papadakis M.

28. Vet Q. 2016, 36(2):56-62. Evaluation of intra-articular injection of autologous platelet lysate (PL) in horses with osteoarthritis of the distal interphalangeal joint.Tyrnenopoulou P, Diakakis N, Karayannopoulou M, Savvas I, Koliakos G.

29. Iranian Journal of Veterinary research Shiraz University 2016, vol 17, No 1, Ser. No 54, 59-61. Successful  management of an equine carpal chip fracture by intra-articulary injected adipose-derived stromal vascular fraction after arthroscopic removal.  Tyrnenopoulou P. , Karayannopoulou M, Angelopoulou S. , Pyrros A. , Mparous E. , Koliakos G. and Diakakis N.

30. Histol Histopathol. 2016 Dec 30:11864. doi: 10.14670/HH-11-864.Seven days post-injury fate and effects of genetically labelled adipose-derived mesenchymal cells on a rat traumatic brain injury experimental model.Dori I, Petrakis S, Giannakopoulou A, Bekiari C, Grivas I, Siska EK, Koliakos G, Papadopoulos G. 

31. Free Radic Biol Med. 2016 Dec 27. pii: S0891-5849(16)31136-4. doi: 10.1016/j.freeradbiomed.2016.12.035.

Proteasome activation enhances stemness and lifespan of human mesenchymal stem cells. Kapetanou M, Chondrogianni N, Petrakis S, Koliakos G, Gonos ES.19.

 32. Cytotherapy 2017, 19, 808-820 Human mesenchymal stem cells with enhanced telomerase activity acquire resistance against oxidative stress-induced genomic damage V.  Trachana , S.  Petrakis, Z. Fotiadis, E. Siska, V.  Balis, E. Gonos, M. Kaloyanni,  G.  Koliakos

33. Human mesenchymal stem cells with enhanced telomerase activity acquire resistance against oxidative stress-induced genomic damage.  Cytotherapy, 2017;808-820. V Trachana, S Petrakis, A. Fotiadis, E.Siska, V. Balis,E. Gonos, M. Kaloyanni and G. Koliakos.

34.Stem Cells and Aging. Koliakos G. Rejuvenation Res. 2017 Feb;20(1):4-8.

35. Generation of an immortalized mesenchymal stem cell line producing a secreted biosensor protein for glucose monitoring. Siska EK, Weisman I, Romano J, Ivics Z, Izsvák Z, Barkai U, Petrakis S, Koliakos G. PLoS One. 2017 Sep 26;12(9):e0185498.

36. J Wound Care. 2018 Oct 2;27(10):637-644. doi: 10.12968/jowc.2018.27.10.637. Adipose-derived stromal vascular fraction aids epithelialisation and angiogenesis in an animal model. Karagergou E, Dionyssopoulos A, Karayannopoulou M, Psalla D, Theodoridis A, Demiri E, Koliakos G.

37. Regen Med. 2018 Apr;13(3):277-281. doi: 10.2217/rme-2017-0069. Accelerated healing of a diabetic foot ulcer using autologous stromal vascular fraction suspended in platelet-rich plasma. Didangelos T, Koliakos G, Kouzi K, Arsos G, Kotzampassi K, Tziomalos K, Karamanos D, Hatzitolios AI.

38.Cytotherapy. 2018. pii: S1465-3249(18)30694-7. Isolation of a novel embryonic stem cell cord blood-derived population with in vitro hematopoietic capacity in the presence of Wharton's jelly-derived mesenchymal stromal cells. Gounari E, Daniilidis A, Tsagias N, Michopoulou A, Kouzi K, Koliakos G.

39. Stem Cell Res Ther. 2018 Dec 7;9(1):336. doi: 10.1186/s13287-018-1078-8. Mesenchymal stem cells in preclinical cancer cytotherapy: a systematic review.Ι, Goulielmaki M, Devetzi M, Panagiotidis M, Koliakos G, Zoumpourlis V.

 

40.Differentiation Capacity of Monocyte-Derived Multipotential Cells on Nanocomposite Poly(e-caprolactone)-Based Thin Films. Koliakou I, Gounari E, Nerantzaki M, Pavlidou E, Bikiaris D, Kaloyianni M, Koliakos G. Tissue Eng Regen Med. 2019 Mar 18;16(2):161-175. doi: 10.1007/s13770-019-00185-z. eCollection 

 

Biohellenika, an AABB (American Association of Blood Banks) accredited company supports a very strong R&D Department. Highly educated scientists make a remarkable effort in order to improve existed protocols or to launch new products into the market. Thirty  two  papers have been published in distinguished international journals, five patents have been granted and seven  clinical trials have been supported by this Department. Also many awards are granted to Biohellenika for the pioneer work that has provided. Six  PhD theses were supported by Biohellenika and three more are in progress.

AWARDS

  • The 1st Award was granted in April 2007 by the Medical Society of Thessaloniki during the 22nd North Greece Medical Conference, concerning the in vitro transformation of progenitor stem cells from the bone marrow to cells of the myocardium, for their future use in patients with myocardial infarction.
  • The 2nd Award was granted in May 2007 by the Athens Medical Society during the 33rd Pan-Hellenic Medical Conference, for Biohellenika’s specialized technique of isolation of stem cells with multipotent properties from the placenta drainage.
  • The 3rd Award was granted in December 2007 by the Pan-Hellenic Transplantation Society during their 15th Pan-Hellenic Conference, for Biohellenika’s research in the attainment of an additional number of haematopoietic stem cells after draining of the placenta. The adequate number is gained for the treatment of adult patients and especially those with a large body mass.
  • The 1st Award from Kerameos foundation in November 2010 by the Cardiovascular Society in the frame of 8th Congress on Cardiovascular Surgery for the combined supporting of left ventricular with bone marrow stem cells and device.
  • Award in March 2011 in the frame of 26th Northern Greece Medical Congress for in vitro differentiation of umbilical cord multypotent stem cells to neural cells.
  • Biohellenika was awarded in the frame of the 27th Northwestern Medical Congress Thessaloniki 2012 for “Methods of pluripotent stem cells separation and characterization from cord blood, placenta, umbilical cord and adipose tissue".

PARTICIPATION IN CONGRESSES

·         Kouzi-Koliakos K.  “Collection, processing, quality control and cryopreservation of umbilical cord blood stem cells.”  European Society of Gynaecological Oncology. Perspectives in gynaecological oncology & colposcopy teaching session. Skopia, September 28-30, 2007

·         Tsagias Ν., Κouzi-Koliakou Κ., Κaragiannis V., Ιoannidou Ε., Koliakos G. “Isolation, cryopreservation and culture of stem cells from the umbilical cord blood” 21st Northern Greek Medical Congress, Thessaloniki 2007.

·         Tsagias Ν., Kouzi-Koliakou Κ., Karagiannis V., Ioannidou Ε., Koliakos G. “Isolation and proliferation of monocyte population, from adult’s peripheral blood” 21st Northern Greek Medical Congress 2007.

·         Tsagias Ν., Kouzi-Koliakou Κ., Κaragiannis V., Ioannidou Ε., Koliakos G. “Isolation, culture and cryopreservation of stem cells from umbilical cord blood and adult’s peripheral blood” 28thBiology Congress Kavala 2007

·         Tsagias Ν. Hamidi-Alamdari D., Kouzi-Koliakou Κ., Michaloudi Ε., Karagiannis V., Koliakos G. “High recovery of stem cells from the umbilical cord blood using a triple collection bag” 19thPan-Hellenic  Hematologic Congress 2007

·         Daniilidis Α., Klearchou Ν., Kouzi-Koliakou Κ., Tsagias Ν., Mauromichali Μ., Karagiannis V. “Tracing of foetal erythrocytes in the circulation of pregnant women” 4th Pan-Hellenic Congress of the Greek Embryology Medicine, Kamena Vourla 2006

·         Kouzi-Koliakou Κ. “Present and future applications of the stem cells from the umbilical cord blood” 10th Pan-Hellenic Congress. The Pan-Hellenic Congress. The development of obstetrics science, Patra 2006.

·         Tsagias Ν., Hamidi Alamdari D., Kouzi-Koliakou Κ., Koliakos G. “Isolation and identification of the pluripotent population of stem cells from placenta” Award Best Study in Applied Research. 33rd Pan-Hellenic Medical Congress Athens 2007.

·         Antonitsis P., Ioannidou Ε., Kaidoglou Α., Kouzi-Koliakou Κ., Kalogeridis Α., Klonizakis Ι., Moros Ι., Papakonstantinou Ch. “In vitro study for the transformation of the primitive mesenchymal cells from the bone marrow into myocardial cells” Award 22nd Pan-Hellenic Medical Congress Thessaloniki 2007.

·         Kouzi-Koliakou Κ. “Present and future applications of stem cells from the umbilical cord blood” Obstetrics and Gynecological Clinic, University of Ioanninon, Medical School. Continuous training programme for doctors, 2006-2007.

·         Tsagias Ν., Kouzi-Koliakou K., Β. Karagiannis V., Koliakos G. “New method to collect increased amount of primitive hematopoietic cells from the umbilical cord-placenta, sufficient for adult transplantation” 15th Pan-Hellenic Transplantation Congress Thessaloniki 2007, Award by the Greek Transplantation Organisation.

·         Kouzi-Koliakou K. “Present and future application of stem cells” Round Table 5th Congress Εμβρυομητρικής Medicine Volos, 19/5/2008.

·         Kouzi-Koliakou K., Koliakos G., Karakitsos G., Karanastasi S. “Mesenchymal stem cells from deciduous teeth and third molars” 38th Pan-Hellenic Dental Congress Patra 2008

CLINICAL TRIALS

  1. Bone marrow stem cells transplantation into the heart muscle during by-pass surgery for improvement of the cardiac function after heart attack. Twenty patients already are enrolled.Two publications
  2. Treatment of autistic children with own stem cells from cord blood (hematopoietic stem cells) or cord tissue (mesenchymal stem cells). 230 children are enrolled. Presentation in Congress
  3. Treatment of patients with Idiopathic pulmonary fibrosis and chronic pulmonary obstruction. 80 patients are enrolled. Three publications
  4. Treatment of knee and hip osteoarthritis. Comparison of chondrocytes and adipose tissue mesenchymal stem cells differentiated to chondrocytes implantation into the degenerated cartilage. 61 patients are enrolled.
  5. Clinical trial for face regeneration with fibroblasts. Fibroblasts are extracted from a small skin biopsy from the  area behind the ear or gums and cultured until to reach the appropriate number of cells, depends on the area we want to rejuvenate. 35 women have been enrolled
  6. Cerebral palsy (Metropolitan Hospital Athens). 12 children are enrolled
  7. Would healing, diabetic foot, pressure ulcers  (Aristotle University Thessaloniki). Presentation in Congress

Biohellenika established a state of the art Stem Cell Bank that includes two laboratories and storage facilities, one in Thessaloniki and one in Athens. Today Biohellenika stem cell bank is one of the most prominent stem cell banks in Greece, with a more than 65% market share. (In Greece today operate 7 family stem cell banks). Biohellenika has  an inventory of more than 30.000 cord blood and 5.000 deciduous tooth collected units, and is the only stem cell bank in Greece that has successfully released units to a USA Duke Hematology Clinic for autologous therapeutic use. Biohellenika has successfully supported up to date more than 977 autologous therapies in Greece and abroad. 

Biohellenika is accredited by the American Association of Blood Banks (AABB) (September 2010). Biohellenika is also accredited according to ISO 15189:2012 by the Hellenic National Accreditation System with the document No 410, 8/2/2008.

Biohellenika has also certified its innovative storage system as a medical device according to ISO 13485.

Clean room operation is certified according to System of Good Manufacturing practices (2017).

Biohellenika is certified according to the International Quality Management Systems Standard ISO 9001:2015 for the processing, qualitative controls and preservation of autologous cell systems (hematopoietic autografts from the umbilical blood and placenta; and  mesenchymal autografts from the pulp of deciduous teeth and third molars; adipose tissue and wharton’s jelly), from the Lloyds' Register Quality Assurance International Accreditation Group.

The quality system includes also a customized CRM, ISBT 128 Barcoding system for the traceability, is fully computerized, includes training and is designed to be easily transferable to new affiliated laboratories. Biohellenika’s laboratories and stem cell banking facilities meet all necessary requirements defined by the EU Commission Directive 2006/17/EC.
The laboratories of Biohellenika fully operate 24 hours a day, 7 days a week, 365 days a year and provide standard operation proceedings  of stem cell processing and storage. The central laboratories, total area of 2700m², lie at the headquarters of the company, 65 Georgikis Scholis Avenue, at the exit of Thessaloniki to the airport, in the professional use building <<ZEDA>>. The Athens laboratories are situated in an independent building (800 m²), close to the center.