Ministry of Health of the Slovak Republic
E t i c k á        k o m i s i a

Order No 39/45

Current Opinion of the Ethics Committee of the Ministry of Health of the Slovak Republic.
(date of adoption: 27.11.2012)

Donation, storage and use
stem blood-forming cells from cord blood
(III Opinion on the subject)

The above issues are already raised by the Ethics Committee of MZ SR (hereinafter referred to as MZ SR) has repeatedly dealt with in detail in the past and has already adopted 2 on the subject. Resolutions/Opinions

  1. Resolution 25/21, published on the website of MZ SR 16.10.2008

  2. Resolution 32/39 of 29.11.2011

Parameter (s) of solution: ethical, legal, factual, financial

Participation of invited experts/relevant bodies: representatives of the company Eurocord - Slovakia (Slovak Placental Cell Register) (hereinafter referred to as "Eurocord"), representatives of the Slovak National Transfusion Service, main expert of MZ SR for haematology, main expert of MZ SR for transfusionology

In its current opinion EtK MZ SR also states:

1. Regulation of collection, processing, storage and release for application stem blood-forming cells from cord blood

  • Stem haematopoietic cells from cord blood (hereinafter referred to as "PUK') within the meaning of Act No 362/2011 Coll. on medicinal products and medical devices and on change; and the addition of certain laws as amended are still included Human transfusion medicinal products.

  • There is still a state where in accordance with Act No. 576/2004 Coll. on Health care (as amended) the PUK is excluded from the definition tissue, transplant and tissue bank.

  • The relevant European directives - Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 setting standards of quality and safety for donation, procurement, testing, the processing, preservation, storage and distribution of human tissues and cells; and Commission Directive 2006/17/EC of 8 February 2006, implementing the Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements donation, procurement and testing of human tissues and cells.
         The directives in question could be transposed into Slovak legislation without authorising provision in the relevant law through Approximation Regulation of the Government of the Slovak Republic but under such conditions as to avoid the current double-trackness of the solution to the issue at issue - i.e. in terms of transfusion product on one side and human tissue and cells on the other.

  • There is currently no general binding regulation/technical guidance on the issue of PUK with particular emphasis on its use for autologous/allogeneic * transplant.

2. True public information

Basic ethical issues

  • Objective of Eurocord's procurement information and its subsequent use for autologous/allogenic transplantation.

  • Problem of procurement and treatment of PUK for allogeneic transplantation.

Ethical problems/dilems in detail/in detail

  • Basic differences between the views of the relevant main experts of the Slovak Republic, respectively. of the SLS Haematological and Transfusiological Society, on the one hand, and Eurocord representatives, on the other hand, within the scope of use of autologous/allogenic PUK transplant.

Tab 1: Examples of differences in the use of PUK based on the relationship of its source
(source: materials of Eurocord and major expert of MZ SR for haematology)

Disease Eurocord's Opinion Opinion of the principal expert of MZ SR on haematology
  PUK own (autologous) PUK Foreign (allogenic) PUK own (autologous) PUK Foreign (allogenic)
Acute leukaemias
Acute lymphoid leukaemia yes 1) yes no yes
Acute myeloblast leukaemia yes 2) yes no yes
Chronic leukaemias
Chronic lymphocytic leukaemia yes yes no no
Chronic myeloid leukaemia (CML) yes 4) yes5) no no
Juvenile myelomonocytic leukaemia yes 4) yes no yes, very rarely
Myelodysplastic syndromes yes 4) yes no no
Blood and lymphatic system disorders
Acquired disorders (aplastic anaemia) yes6) yes test yes
Night Paroxysomal Haemoglobinuria yes yes no yes
Myeloproliferative disorders
Osteomyelofibrosis yes 4) yes no no
Lymphoproliferative disorders
Hodgkin's Disease yes yes test yes, very rarely
Non-Hodgkin's lymphomas yes yes no yes
Plasmacytic disease
Multiple myeloma (Plasmocytoma) yes yes no no
Other malignancies
Brain tumors yes (yes) test no
Ewing's sarcoma yes (yes) test no
Neuroblastoma yes yes test no
Kidney Carcina (yes) (yes) test no
Autoimmune disorders
Multiple sclerosis yes yes no no
Rheumatoid arthritis yes yes no no
Systemic lupus erythematosus yes yes no no

Explanatory notes (source: Eurocord materials)

1) Use of cord blood is only possible for some subtypes this diagnosis (first successful use of own cord blood in ALL) published in 2007). However, preference should normally be given to transplant from sibling or non-related donor if available.

2) For some high-risk subtypes of this diagnosis, preferred transplant from sibling or other donor if c available.

4) As it is mainly an adult disease, experience with cord blood not yet available but most likely an autologous transplant would be used if no suitable donor was found.

5) In this diagnosis cord blood was used for both transplantation and Slovakia.

6) In case of bone marrow failure that is not rare in the paediatric population, the dose should be reduced accordingly. preferred allogeneic transplantation from the HLA-identical sibling. In case of that the HLA-identical sibling was not, a transplant of his own would be used cord blood.

(yes) transplantation can be done, but currently there is still a only the subject of research, real significance will be shown in the future.

  • Sufficient, comprehensible, clear, unambiguous, balanced and complete information the general public with emphasis on the subsequent use of the PUK and the fact of its minimum use by the donor of PUK alone in autologous transplantation.
          In addition, the stored PUK of one and the same person (autologous PUK) may contain the same cells that caused the disease.

  • PUK options and their advantage over stem cells from other sources (peripheral blood, bone marrow, fat tissue...) in regenerative medicine.

  • Support for private storage of PUK (autologous transplant)

  • Public awareness of PUK on the basis of resources -Evidence Based Medicine and published opinions of professional companies (e.g. Haematological and Transfusion Society of SLS) and not based on unsubstantiated, unverified facts assumptions, hypotheses. European Commission so far has not changed its negative opinion on autologous sampling and use of PUK.

3. Informed Consent for procurement, Processing, storage, use of stem cord blood haematopoietic cells

  • The informed consent is to be obtained directly by the employee or person in the same employment relationship with Eurocord and not intermediary, for remuneration, a healthcare professional who is, within the meaning of the legislation in force, responsible only for the correct provision of healthcare (i.e. performance cord blood collection) and not for other services provided by cord bank blood.

  • Informed consent must be obtained during pregnancy and not in frontiers, stress situations (i.e. during childbirth and the like). Another procedure is serious suspected conflicts of interest as well as ethics in the pursuit of the health profession.

  • The informed consent of Eurocord shall include:

    • Data on the processing and storage of the tissue collected.

    • How to conclude the relevant agreements with Eurocord and their consequences no closure.

    • Information on the protection of personal data and health data of the future mother concluding a contract and providing such data where it is justified the medical facility shall provide this data to Eurocorda.

    • Information that the amount of blood collected (predefined...) does not need be sufficient for future use.

  • The informed Eurocord consent shall not contain:

    • Clear, understandable, unambiguous, balanced and complete information on the reason for the procurement PUK, as well as the potential benefit, risk and probability of using PUK for this purpose/objective. Contains only reference to additional material; possible contradiction with valid by law (in particular Law No 576/2004). Z. z.), when informed consent, i.e. to avoid proper instruction on the purpose, nature, consequences and the risks of healthcare provision, the options proposed procedures and risks of refusal to provide healthcare. Touched a person/legal representative is to be given sufficient time for a free decision.

  • The person (s) concerned must not be misled by unverified information on potential use of PUK for the treatment of diseases in the donor (child) alone v future or for tissue regeneration. Information must respect the obligation honesty/trueness to the public to which they are addressed.

4. Establishment of a non-commercial nationwide cord blood biobank

  • EtK MZ SR considered it necessary to create conditions for establishment and proper the functioning of a nationwide blood stem cell biobank from corded blood cells blood for allogeneic use based on non-profit principles and at least partially financed by public health insurance or public health insurance the budget so that it can be accessible and serve as broad a public as possible.

5. Conclusion

  • EtK MZ SR states that since the adoption of its first opinion/order no shift in the comprehensive solution of the issue by the State.

Chairman: MUDr. P. Križan, CSc.; Secretary: Mgr. P. Valúch Tel. (02)59 373 362, e-mail: peter.valuch@health.gov.sk Ministry of Health SR, Limbová 2, 837 52 Bratislava, Slovenská Republic

Legend:

* Autologous transplantation of the donor and recipient of the PUK is one and the same person.
* Allogeneic transplant - donor and recipient of PUK are different persons.
** Regenerative medicine - an area of medicine used to restore the damaged tissues and organs stem cells from various sources (PUK, bone marrow, peripheral blood, fat tissue...)