Why Preservation is Important
- Dr. Koliakos
Why Preservation is Important
Whoever has an active role in healthcare and welcomes the idea of regenerative medicine should inform and suggest the preservation of adipose-derived primitive and regenerative cells. Scientific studies have shown that these cells have the potential to play an important role in personalized regenerative medicine.
Consult your doctor and ask for more information regarding the next steps. We also invite you to visit our website www.biohellenika.gr for further information.
Biohellenika is certified according to ISO 9001:2008 by Lloyd's Register Quality Assurance for the process, quality test and cryopreservation of autologous cell population from adipose tissue.
The function of separation and cryopreservation laboratories is adjusted to the NATIONAL LEGISLATION demands, the European Instructions, the AABB regulations, JACIE and Netcord, and the ISO 9001,13485, 14644, 15189 και 27001. The equipment used carries the CE badge, while all materials are approved for human therapeutic use (EOF).
Biohellenika has received all permits demanded by Greek legislation, thus always functioning legally, the laboratories abide by all relevant international regulations and are under evaluation for the AABB (American Association of Blood Banks) certification.
Biohellenika has today 8 clean rooms, 5 in Thessaloniki and 3 in Athens, that are specially designed for the processing of the cord
stem cells. The clean rooms are certified according to the GMp and ISO 14644-5 και VDI 2083 standards. The company follows all ISO
13485 safety regulations (medical equipment) and ISO 27001 (data safety).
The Advantages of Biohellenika
Biohellenika, one of the biggest Greek Stem Cells Bank in Europe, offers high quality, scientifically proven innovative services which derive from the long experience and research of distinguished scientists. Get to know Biohellenika, a company of high standards and strict operation criteria, where science is the foundation of human life.
Biohellenika is the only company today that uses the latest technologically advanced equipment that follows a Certified Procedure
that guarantees safety during the whole procedure.
Within the frame of unique benefits, Biohellenika's innovative services are offered at special prices with favourable financial settlement terms.
- Adipose Tissue-Derived Stem Cells. Characterization and Potential for Cardiovascular Repair, Madonna R, Geng YJ, De Caterina, Arterioscler Thromb Vasc Biol. 2009 Jul 23
- [Regenerative medicine for anti-aging], Ebisawa K, Kagami H, Kato R, Yamada Y, Ueda M. Nippon Rinsho. 2009 Jul;67(7):1402-6
- Human adipose derived stem cells contribute to chondrogenesis in co-culture with human articular chondrocytes, Hildner F, Concaro SE, Peterbauer A, Wolbank S, Danzer M, Lindahl A, Gatenholm P, Redl H, van Griensven M., Tissue Eng Part A. 2009 Jul 8
- Early translation of adipose-derived cell therapy for cardiovascular disease, Sanz-Ruiz R, Fernández-Santos E, Domínguez-Muñoa M, Parma R, Villa A, Fernández L, Sánchez PL, Fernández-Avilés F., Cell Transplant. 2009;18(3):245-54
- Clinical study of the efficiency of combined cell transplant on the basis of multipotent mesenchymal stromal adipose tissue cells in patients with pronounced deficit of the maxillary and mandibulary bone tissue, Kulakov AA, Goldshtein DV, Grigoryan AS, Rzhaninova AA, Alekseeva IS, Arutyunyan IV, Volkov AV., Bull Exp Biol Med. 2008 Oct;146(4):522-5
- A new bronchoscopic treatment of tracheomediastinal fistula using autologous adipose-deirved stem cells. Alvarez PD, García-Arranz M, Georgiev-Hristov T, García-Olmo D. Thorax 2008
- Adipose-Derived Stem Cells and Their Secretory Factors as a Promising Therapy for Skin Aging, Park BS, Jang KA, Sung JH, Park JS, Kwon YH, Kim KJ, Kim WS, Dermatol. Surg. 2008
- Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells, Rigotti G, Marchi A, Galiè M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A., Plastic and Reconstructive Surgery 2007
- Treatment of resistant pure red cell aplasia after major ABO-incompatible bone marrow transplantation with human adipose tissue-derived mesenchymal stem cells, Baijun Fang, Yongping Song, Robert Chunhua Zhao, Qin Han, Ying Cao, American Journal of Hematology 2007
- Human adipose tissue-derived mesenchymal stromal cells as salvage therapy for treatment of severe refractory acute graft-vs.-host disease in two children, Fang B, Song Y, Lin Q, Zhang Y, Cao Y, Zhao RC, Ma Y, Ediatric Transplantation 2007
- Adipose-Derived Cells, Emanuele Meliga, Brian M. Strem, H.J. Duckers and Patrick W. Serruys, Cell Transplantation Review 2007
- Multipotential differentiation of adipose tissue-derived stem cells, Brian M Strem, Kevin C Hicok, Min Zhu, Isabella Wulur, Zeni Alfonso, Ronda E Schreiber, John K Fraser and Marc H Hedrick, The Keio Journal of Medicine 2005
Expanded access cord blood for cerebral palsy and autism to siblings
- Dr. Kouzi
Featured Advanced Cell Therapy Trial: Expanded Access Cord Blood Therapy for Autism and Cerebral Palsy
Duke University Medical Center has received permission from the FDA to offer cord blood therapy for conditions like autism spectrum disorder and cerebral palsy under an expanded access clinical trial. This protocol establishes an umbrella clinical trial NCT03327467registered on 31 Oct. 2017 which enables children who have these neurological disorders to receive therapy with their own cord blood or cord blood from a sibling, regardless of whether they qualify for a targeted clinical trial.
The registration of this clinical trial is a watershed moment, opening the door for many children who are afflicted with an acquired neurological disorder to travel to Duke University for cord blood therapy, provided they have a suffienctly matching cord blood unit in a family bank. Sibling therapy only requires a partial match, not a perfect match. This expanded access protocol is a triple win for patients, family cord blood banks, and Duke University Medical Center.
The FDA may grant permission for expedited access (aka expanded access) under one of four designation pathways. In order to be considered for the FDA's expedited access prorgram, the new therapy must treat a “serious condition” that that has substantial impact on day-to-day functioning. In addition, there must be an “unmet medical need” because the condition is not addressed adequately by therapeutic alternatives.
The Breakthrough Therapy designation for expedited access is based on the results of phase 2 clinical trials. Duke University has conducted multiple clinical trials investigating the use of both autologous and allogeneic umbilical cord blood (UCB) in the treatment of cerebral palsy (NCT01147653, NCT02599207) and autism spectrum disorder (NCT02847182). As stated in the new open access clinical trial, “The use of (UCB) in this fashion is based on safety and efficacy data from prior and ongoing clinical trials at Duke University Medical Center in over 700 patients with these diagnoses infused with autologous or sibling UCB over the past decade.”
In the United States, the Centers for Disease Control and Prevention reports that the prevalence of cerebral palsy is 1 in 323 children (0.3%) and the prevalence of autism spectrum disorder is 1 in 68 children (1.5%). However, in order to be eligible to participate in the new clinical trial, patients must have their own or a sibling’s cord blood preserved in a family bank. To date, the only study that has examined the prevalence of medical conditions among families with privately stored cord blood is a recent publication that surveyed clients of Cord Blood Registry®(CBR®). The authors found that, out of 94,803 respondent families, 4.23% reported at least one child with an indication for regenerative therapy with cord blood. For conditions similar to autism spectrum disorder and cerebral palsy, the combined prevalence was 2.18%.
Worldwide, there are projected to be tens of thousands of children who are eligible to take advantage of this new treatment pathway. In the United States alone, there are over a million cord blood units in family storage, so that if 2% of the inventory corresponds to children with eligible conditions, that potentially translates into 20,000 patients.
Breaking News: The Cord Blood Association (CBA) announces 13 Nov. 2017 they are seeking funds to convert this protocol into a multi-center clinical trial administered by CBA and Duke.
Cell Trials Data is a project of Parent's Guide to Cord Blood® Foundation, a 501(c)(3) non-profit organization that is headquartered in the United States at 23110 Georgia Ave., Brookeville MD 20833. For more information visit https://parentsguidecordblood.org