Ukraine has always been famous all over the world for the significant achievements in the field of cryobiology and cryomedicine, being ahead of the world’s best venues thanks to the methods of cryopreservation of biological material, developed by national scientists. In 1984, in Ukraine for the first time in Europe the umbilical cord blood samples were frozen. However, due to a number of socio-economic factors, the industry of cord blood banking in Ukraine emerged and developed a bit different way, compared to the European countries.
In the developed countries of the world at the end of XX – beginning of XXI century, taking into account the needs of hematologic clinics in hematopoietic stem cells transplants, the high cost and limited availability of bone marrow samples with rare phenotypes public cord blood banks appeared, funded by the state. The service of personal storage of umbilical cord blood for the needs of the family emerged on the global medical market just with time, and as of today a fairly strong culture of “’biological” insurance developed.
Ukraine, in this period, since it won independence in 1991, was passing difficult stages of the state formation, building of the own economy and health system. Therefore cord blood banking in Ukraine started with the services of personal storage of stem cells, when in 2003 at the Institute of Cell Therapy the first cryobank of the umbilical cord blood in the country was founded. Enthuastic Ukrainian scientists played a significant role in the establishment of cord blood banking in Ukraine, trying to implement the methods of cryopreservation of stem cells and tissues, they developed, complying with the highest international standards in practical health care.
The relevance of cord blood banking in Ukraine was determined by the high incidence of oncohematologic morbidity after the disaster at the Chernobyl nuclear station in 1986, the lack of public registry of hematopoietic stem cells and the high Slavonian culture of the conscious parenting. However, despite the lack of state funding, Ukrainian cryobiology, including scientists of the Institute of Cell Therapy during recent 10 years significantly strengthened its image on the international scientific arena, having received the international recognition, numerous foreign awards and distinctions.
In Ukraine, the development of legislation regulating the activities of banks of umbilical cord blood and other human tissues and cells occurred concomitantly with the development of this branch of medicine. And today, the acts of legal regulation of the activities of cryobanks in the country are quite perfect and harmonious in compliance with the relevant international documents.
Actually the activity of cord blood banks, other human tissues and cells in Ukraine is regulated by the following laws, decrees and regulations:
The Law of Ukraine “On the Transplantation of Organs and Other Anatomical Materials in Humans”
This Act due to the current state of the science and recommendations of the World Health Organization defines the conditions and procedures for applying the method of transplantation as a special treatment, ensures the compliance of human rights and human dignity in Ukraine in the application of transplantation and other related activities.
Order of the Ministry of Health of Ukraine “On Approval of the Procedure of the Collection and Temporary Storage of Umbilical Cord (Placental) Blood”
Regulates the collection and temporary storage of umbilical cord (placental) blood, establishes the forms and procedure of conduction of the accompanying documentation.
Order of the Ministry of Health of Ukraine “On Approval of the License Terms of Business Activities of the Banks of Umbilical Cord Blood and Other Human Tissues and Cells”
Establishes License conditions of the operating of the business activity of the banks of the umbilical cord blood, other human tissues and cells.
Order of the Ministry of Health of Ukraine “On Approval of the Procedure for Conducting Clinical Trials of Tissue and Cell Transplants and Expertise of the Materials of the Clinical Trials”.
Establishes the Conditions of the conduction of clinical trials of tissue and cell transplants and expertise of the materials of the clinical trials.
Resolution of the Cabinet of Ministers of Ukraine “On Measures for the Organization of Health Care and Research Institutions Associated with Transplantation of Organs, Tissues and Cells”.
Regulates the use of tissues and cells transplants as a treatment by health and academic institutions, regardless of their subordination solely on the basis of a permission issued according to the results of clinical trials. The order approves clinical trials of tissue and cell transplants and expertise of the materials of clinical trials considering their application in clinical practice.
The Law of Ukraine “On the Donorship of Blood and its Components”
Thus, the Law of Ukraine “On Licensing of the Certain Types of Activities” Article 9, Part 3, paragraph 22), provided that such type of activity as: “The activities of banks of umbilical cord blood, other human tissues and cells” should be licensed. The decree of the Cabinet of Ministers of Ukraine of 27.07.2011, № 798 defined the State Service of Ukraine on Fighting with HIV-infection/AIDS And Other Socially Dangerous Diseases as the licensing body of the “Activities of the Bank of Umbilical Cord Blood, Other Human Tissues and Cells”. The Decree of the Ministry of Health of 10.04. 2012, № 251, approved “Licensing Terms for the Activity of Banks of Umbilical Cord Blood, Other Human Tissues and Cells.”
All organizations involved in processing and storage of umbilical cord blood in Ukraine, shall meet the conditions of the license and a obtain a license for “The Activities of Banks of Umbilical Cord Blood and Other Human Tissues and Cells.”
The licensing conditions implicate the following:
- Compliance of processes and techniques of cryopreservation and long-term storage with the requirements of the Ministry of Health.
- Testing samples for viral infections in accordance with the requirements of the Ministry of Health for the possibility of their future clinical use.
- Qualitative analysis of the sample. Determination of the amount of stem cells, contained in the umbilical cord blood.
- The presence of the appropriate medical and/or biological education.
- Higher medical or biological education of the chief of the umbilical cord blood bank.
- Regular attestation of the staff.
Concerning the material base:
- The area should be not less than 50o square meters.
- Reserved storage of liquid nitrogen with the capacity of not less than 1 ton.
- The availability of the devices and equipment in accordance with the table of equipping.
- The availability of the own PCR-laboratory.
It should be noted that officially Ukraine became the first state in the Union of Independent States, where the methods of stem cells treatment received state registration.
In 2012, the Ministry of Health of Ukraine officially approved the methods of treatment of pancreonecrosis, critical lower limbs ischemia, burns, chillblains and injuries with the use of cell preparations, developed by the Institute of Cell Therapy (Kiev) and Gusak Institute of Urgent and Reconstructive Surgery (Donetsk).