CORD BLOOD. THE WORLD LEGISLATION.

The banking of cord blood and other tissues can be compared with the production of cell transplants which:

• Should be sterile.
• Number of viable cells should be sufficient to restore the hematopoiesis and further functioning of the graft.
• Should not contain any dangerous cryconservative substances.

Accordingly, the relevant national and international committees were created in the world for the regulation of this extremely important process, licensing terms of the banks of cord blood banks, other cells and tissues were approved, a variety of respective laws and regulations were established.

At the same time, due to the high medical and biological value of umbilical cord blood in the developed world a number of state and humanitarian organizations actively conduct educational work, aimed to encourage pregnant ladies to a voluntary donation of umbilical cord blood collected at birth to the state cryobanks and to inform them about their right to preserve it, if desired, in the bank of personal storage as a “biological insurance” for their own families.

To date, 23 countries of the world established the laws requiring doctors to inform the expectant parents about the possibilities of personal preservation of umbilical cord blood or its donation to the state banks.

Such a law is valid in half of U.S. states, obliging obstetricians and gynecologists to inform pregnant women about the value of cord blood and opportunities to preserve it. Also in USA, in 2009, the addition to the tax code was approved, according to which the cost of a private cord blood preservation is calculated from annual taxes of the parents. Umbilical cord blood banking in the USA is also supported by a charitable organization “Red Cross”.

Storage and clinical use of cord blood cells and other tissues of the adult body is absolutely ethical and approved by all the religions of the world, and cord blood banks are actively functioning both in strict Catholic, Orthodox and Muslim countries, as well as in India and Japan.

The catholic Capital of the World Vatican in 2010 allocated two billion euros for research of adult stem cells. Also in Vatican the Pontifical Council for Culture holds regular scientific conferences devoted to modern capabilities of cell therapy and its relation to issues of culture, ethics and faith.

Throughout the world, stem cell therapy can be carried out only in hospitals licensed for this type of activity, and according to protocols approved by the appropriate regulatory authorities in the field of health care.

One of the most important international organizations that oversee the clinical application of stem cells are the European Association for the Bone Marrow Transplantation (EBMT), EUROCORD, American Association of Blood Banks (AABB), U.S. Food and Drug Administration (FDA), World Health Organization (WHO). In the European Union, cord blood banking is regulated by the Directive of European Parliament and of the Council of Europe “On Approval of the Quality Standards for the Donation, Procurement, Testing, Preservation and Storage of Human Tissues and Cells.”

International accreditation standards for cord blood banks

Cord blood banking may be considered completely comparable with complicated technologies of manufacturing of modern drugs since the purpose of isolation and cryopreservation of stem cells from umbilical cord blood is the production of immunobiological preparation suitable for both autologous and allogeneic use. Although in comparison with the pharmaceutical industry, processing and cryopreservation of umbilical cord blood is also characterized by additional risks, including the possibility of infecting the recipient of biological material, as well as by a number of ethical issues. Therefore, cord blood banking in all countries is a subject of strict regulation by numerous national and international legal acts.

At the same time, effective application of cord blood stem cells is possible only under the conditions of harmonious interaction of biobanks, stem cells registries and hematologic clinics/regenerative therapy centres and the possibility of operative transfer of the stem cell transplant from the biobank to the clinic, which often are not only in different countries, but also on different continents. Only meeting of certain international accreditation standards by cord blood biobank ensures a provision of a high-quality cell transplant to the medical centers.

To date, the following accreditation standards have been adopted in the world practice of banking of cord blood stem cells:

1) FACT (Foundation for the Accreditation of Cellular Therapy).

Foundation of Accreditation of Cellular Therapy is a non-profit organization dedicated to the development of standards, accreditation and education in the field of cell therapy and regenerative medicine. Foundation of Accreditation of Cellular Therapy was founded in 1996 by the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT). Since 2004, the Foundation of Accreditation of Cellular Therapy cooperates with NetCord, an international consortium of umbilical cord blood banks in the direction of the joint development of standards and accreditation. FACT International accreditation covers both public and family cord blood banks.

It is worth noting that the FACT accreditation requirements for banks of umbilical cord blood of a family type and public banks are almost the same, with a few exceptions, according to which the autologous banks is given 72 hours to process the umbilical cord blood after collection, and this time is 48 hours for public banks. FACT is considered to be the most relevant, comprehensive and prestigious accreditation standard.

2) cGMP (Good Manufacturing Practice for Cellular Therapy)

Standards of good manufacturing practice for cell therapy, known as cGMP standards are usually set by the federal government, so may differ between countries. Therefore, in Europe JACIE international standards are introduced.

In the United States, GMP standards are approved by FDA. New licensing requirements FDA BLA demand that public cord blood banks treat cord blood as a drug and follow GMP standards.

3) AABB (American Association of Blood Banks)

Over 20 years, the organization has been developing standards for accreditation of blood banks, and after the necessary audits provides the appropriate accreditation.

4) AATB (American Association of Tissue Banks)  

In the USA banking of cord blood and tissue cryopreservation are regulated by different legal acts. For cord blood banks in the US standard accreditation is AABB or FACT, and for tissue banks – AATB, adopted in 1976. For example, sperm banking is considered as tissue banking and is a subject to AATB accreditation.

5) CLIA (Clinical Laboratory Improvement Amendments)

Clinical Laboratory Improvement Amendments are federal regulatory legal acts in the United States, adopted in 1988. CLIA are mandatory  for all laboratories engaged in patients’ investigations. Thus, CLIA – it’s not the quality accreditation but the necessary legal requirements. Laboratories, registered in the CLIA, every 2 years are exposed to relevant inspection.

6) FDA (Food and Drug Administration)

Food and Drug Administration of the US government deals with the approval of drugs and is a model for the activities of such organizations in many countries. FDA registration is required for all cord blood banks operating in the United States.

7) FDA BLA (FDA license only for cord blood bank)

License FDA BLA, approved in 2011, is required only by the public cord blood banks.

8) JACIE (The Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) – International Group for Blood and Marrow transplantation (IBMT)

JACIE is a nonprofit organization, established in Europe for the accreditation of hospitals involved in cell therapy. JACIE was founded in 1998 by 2 professional societies – the International Society for Cellular Therapy (ISCT) – International Group for Blood and Marrow transplantation (IBMT).

Since 2002 JACIE also collaborates with FACT towards the establishment of international accreditation standards for cell therapy clinics. JACIE standards currently cover only stem cells from such sources as bone marrow, peripheral and cord blood. JACIE mission is to ensure high quality medical services and laboratory investigations through the internationally recognized accreditation system.

9) PharmaStem (nonmedical licence PharmaStem, refers to the laws of patenting)

10) NetCord (International Foundation NetCord)

The International Foundation NetCord is a non-profit association of mainly public cord blood banks. Banks accredited by NetCord, issued more than 10,000 cord blood samples worldwide. NetCord standards are recognized by all programs of stem cell transplantation. In addition to the joint development of FACT accreditation standards and inspection of banks, NetCord promotes research aimed at improving the techniques of collection, testing, storage, ex-vivo expansion of placental and umbilical cord blood and  blood components for cell therapy purposes.

11) ISO (International Organization for Standardization)

 At the same time, relevant national committees control the activities of cryobanks and cell therapy clinics.

Concerning banking and clinical application of cord blood stem cells in the USA, in certain states (eg. California, Maryland, New York, New Jersy) internal Accreditation Standards are accepted. And, it is important to note that accreditation according to these internal quality standards is obligatory not only for biobanks wishing to carry out their economic activities in the state, but also for the possibility to distribute the biological material stored in foreign banks within these states.

In UK the laboratories of cord blood banks  must comply with the state licensing requirements of national governance called Human Tissue Authority.

In Australia, cord blood banks must obtain a certificate of quality TGA (Therapeutic Goods Administration).

In Switzerland, laboratories of cord blood banks require internal accreditation Swissmedic. Swissmedic is part of the Federal Public Health Management in Switzerland.

In India, the cord blood banks are subject to accreditation by DCGI (The Drugs Controller General of India), that is the main authority for the control of medicines.

In Ukraine, the cord blood banks must comply with Licensing conditions for economic activities of banks of umbilical cord blood and other tissues and cells in accordance with the list approved by the Ministry of Health, adopted by the Cabinet of Ministers of Ukraine from 03.02.2016 N 286. and obtain the appropriate license. However, to provide Ukrainian patients the possibility to use their biomaterial, stored in national banks, at foreign clinics it is important that Ukrainian banks meet internationally accepted quality standards and obtain relevant international accreditations.

Today the cryobank of the Institute of Cell Therapy is the only cord blood bank in Ukraine, which is accredited according to ISO 9001: 2008.

Table 1. Regulation of the banking of the umbilical cord blood, other human tissues and cells in different countries of the world.

 Based on the following data: https://parentsguidecordblood.org/en/accreditation; http://www.factwebsite.org/; http://www.aabb.org/; http://www.jacie.org/ and data of the Association of Cryobanks

TO DOWNLOAD INTERNATIONAL STANDARDS: