This is a guest post written by the Association of Cryobanks of Cord Blood and Other Human Tissues and Cells, a Ukraine association that brings together cord blood banks and specialized cryobanks that test and store biological material, including stem cells from umbilical cord blood, bone marrow, reproductive cells and tissues.
It is a timely post as InterFax-Ukraine, a Ukraine News Agency, released an announcement two days ago stating:
The [Ukrainian] Cabinet of Ministers for deregulation of business activities in the field of health care has approved the license terms of economic activities involving the storage of umbilical cord blood and other human tissues and cells.
According to resolution No. 286 of March 2, posted on the government’s website, the document shortens the list of documents submitted for obtaining the license.
While there is undoubtedly regulatory complexity affecting cord blood banking within the Ukraine, this recent resolution suggests that the Ukrainian government is taking measures to improve the situation.
Today’s post from the Ukraine Association of Cryobanks is published with permission from Andrey Makhinya, Secretary of the Association. Enjoy!
Guest Post by the Ukraine Association of Cryobanks of Cord Blood and Other Human Tissues and Cells
Ukraine is famous for significant achievements in the field of cryobiology and cryomedicine, thanks to the methods of cryopreservation of biological material developed by national scientists. In 1984, umbilical cord blood samples were frozen in Ukraine for the first time within Europe. However, due to a number of socio-economic factors, the Ukrainian cord blood banking industry emerged and developed differently than other European countries.
Near the end of 20th century and into the beginning of 21st century, public cord blood banks appeared within developed countries of the world, funded by the state. This was driven by the needs of hematologic clinics for hematopoietic stem cells transplants (HSCT), high cost, and the limited availability of bone marrow samples with rare phenotypes. Private storage of umbilical cord blood for families also emerged as a culture of “’biological” insurance developed.
Because the Ukraine won its independence in 1991, it was passing through difficult stages of state formation at this time, building up its economy and health system. Therefore, cord blood banking in Ukraine started with the private storage of stem cells, when in 2003 at the Institute of Cell Therapy, the first umbilical cord blood bank within the Ukraine was founded.
Enthusiastic Ukrainian scientists played a significant role in the establishment of cord blood banking within Ukraine, trying to implement methods of cryopreservation of stem cells and tissues that they developed and complying with the highest international standards in health care.
The relevance of cord blood banking within 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 conscious parenting. Despite the lack of state funding, Ukrainian cryobiology, including scientists of the Institute of Cell Therapy, significantly strengthened its image within the international scientific arena during past 10 years, having received international recognition that included numerous foreign awards and distinctions.
In the Ukraine, the development of legislation regulating the activities of umbilical cord blood banks and other human tissues and cells occurred concomitantly with the development of this branch of medicine. Today, the acts of legal regulation of the activities of cryobanks within the Ukraine are quite perfect and harmonious in compliance with relevant international documents.
The activity of cord blood banks and other human tissues and cells in Ukraine is regulated by the following laws, decrees, and regulations:
1) 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.
2) 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.
3) 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 storing umbilical cord blood other human tissues and cells.
4. 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.
5. 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.
Licensing Terms and Conditions: 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, states that the “activities of banks storing umbilical cord blood and 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 “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).
ASSOCIATION WEBSITE: http://stemcellbank.org.ua/
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