Elena Bryzgalina. Bioethical and Legal Regulation of the Use of Stem Cells and Stem Cell Technologies in Modern Russia

Bioethical and Legal Regulation of the Use

of Stem Cells and Stem Cell Technologies

in Modern Russia

Elena Bryzgalina

Philosophy Faculty of Moscow State University

The History of Stem Cell Research

Alexander Maximov

(4/2/1874 - 4/12/1928)

an outstanding Russian scientist, one of

the founders of the unitary theory

of hematopoiesis.

Alexander Maksimov was born in St. Petersburg, graduated from the Military Medical Academy. From 1903 to 1922 Alexander Maksimov tutored as professor of histology of the Military

Medical Academy.

The term

"stem cell"

The History of Stem Cell Research

 The first experiments on the practical use of stem cells began in the

early 1950s.

 1970 - The first transplantation of autologous stem cells.

 1988 - Stem cells were first used for transplantation.

 1992 - The first personal collection of stem cells was gathered.

 1997 - Russia was held the first operation to a cancer

patient by transplanting stem cells from umbilical cord blood of infants.

 1998 - The world's first transplantation of the personal cord blood stem

cells to the girl with neuroblastoma (brain tumor). Scientists had found a way to grow stem cells in the nutritional medium.

 1999 - The Journal «Science» acknowledged the discovery of embryonic stem cells the third most important event in biology after decoding the DNA double helix and the program "Human Genome".

The History of Stem Cell Research



2000 – Was held 1200 transplants of cord blood stem cells in

the world.



2001 – Published the first official data on the possibility of

using transplantation of cord blood stem cells in adult patients

(over 90% with good results).



2003 - evidence that after 15 years of storage in liquid nitrogen,

umbilical cord stem cells fully retain their biological

properties. From this point cryogenic storage of stem cells has

been regarded as "biological insurance.“



2004 - The total global collection of umbilical cord blood stem

cells close to 400,000 samples.

The History of Stem Cell Research



2005

- The list of diseases for which treatment can be successfully

used stem cell transplantation, up to several dozen. The focus is on

treatment of malignant tumors and various forms of leukemia and

other blood diseases. There are reports of successful transplantation of

stem cells in diseases of the cardiovascular and nervous

systems. Developed international protocols for treatment of multiple

sclerosis. The treatments to Parkinson's and Alzheimer's disease are

researched.



2010

- In Russia, Federal Service of Healthcare and Social

Development issued the first permit for the use of new medical

technology - (treatment of their own stem cells).



2011

- the draft law on biomedical cell technologies was prepared in

Russia and it received approval from Russian Academy of Sciences

and Russian Academy of Medical Sciences

Draft Federal Law

“On Biomedical Cell Technologies”, 2011

This federal law regulates the relations arising inconnection with

 the development,

 preclinical studies,

 expertise,

 state registration of biomedical cell technologies,

 clinical research,

 production,

 storage,

 disposal,

 use,

 monitoring the use,

 importation into the Russian Federation,

 the export of Russian cellular products.

Draft Federal Law

“On Biomedical Cell Technologies”, 2011

Definition

Stem Cells - Undifferentiated cells that

form a self-sustaining cell population and

capable to differentiate into all types of the

cells of the organism

(pluripotent stem

cells)

or in specialized cells - derivatives of

one or more

(under certain

conditions)

germ layers

(ectoderm,

endoderm

Basic Principles of Stem Cells Research:

 legality;

 the rights and freedoms of man and citizen;

 respect for human dignity;

 voluntary participation in clinical trials of cellular products;

 voluntary provision of patient (donor) of their

cells;

 confidentiality;

 efficacy and safety of biomedical technologies and

stem cell products;

 ban on human cloning;

 ban on the sale of cells derived from the

Sources of Stem Cells in Russia



Aborted material;



"Unclaimed" embryos created for infertility treatment by

in vitro fertilization program;



donations from adults.

Ethical possibility of

obtaining stem

cells from these sources

raises specific bioethical

debate.

The interdisciplinary nature of

bioethics in Russia

In Russia, in the bioethic dialogue important role played by the representatives of different religions.

According to the nationwide survey (March 2010), Russia's population consider themselves the following denominations:

 Orthodoxy - 75%

 Islam - 5%

 Catholicism, Protestantism, Judaism, Buddhism - 1%

 Other denominations - about 1%

 Unbelievers - 8%

 3% of respondents expressed the view that they are believers, but not consider themselves to any particular denomination.

The Attitude of the Russian Orthodox Church

Russian Orthodox Church:



Approves obtaining stem cells from adults and the use of

placental blood.



Prohibits the use of human embryos to derive stem cells.

For the Church there is no fundamental

difference in which period of development was

interrupted the life of a

human embryo. Orthodox religion

believes that a new human life in

which God has breathed life cannot be used in

any way, and her violent interruption is a mortal

sin.

Draft Federal Law

“On Biomedical Cell Technologies”

The draft law states that for the preparation of cell lines can

be used as differentiated cells (except germ cells) and stem

cells.

Moreover, it is said that the human fetal stem cells, should

be segregated from the placenta, umbilical cord and human

umbilical cord blood after normal delivery.

In Russia taking cells

from the embryo

and (or) human fetus is

Cord Blood Banks in Russia

The main objectives of cord blood banks:

1. The organization of preparing and transportation of the umbilical cord/placental blood for scientific research;

2. Testing and typing of prepared umbilical cord/placental blood;

3. Elimination of the concentrate of stem cells from umbilical cord/placental blood;

4. Cryogenic storage of samples of umbilical cord stem cell/placental blood in liquid nitrogen;

5. Providing the samples of stem cells from umbilical cord/placental blood to medical and educational organizations for scientific research;

6. Providing a sample of stem cells from umbilical/placental blood to the physical person in accordance with the terms of the contract concluded with him.

Cord Blood Banks in Russia

1. donors (public), which shall be the umbilical cord / placental blood for public use -their work is funded by the state;

2. personal, private banks storage, in which stem cells are the property of one man and may be used only for him (he accordingly assume all costs associated with preparation and storage).

The largest private stem cell banks:

1. Gemabank: (http://www.gemabank.ru/).

2. Institute of Stem Cell (http://www.teplyashin.ru/). 3. Institute of Biological Medicine (http://www.ibm.ru/).

Cord Blood Banks in Russia

In Russia, the umbilical cord blood sampling is carried

out according to international standards of quality of

segregating and storage of blood stem cells in the banks:

1. Foundation for the Accreditation of Cellular Therapy

(FACT - Foundation for the Accreditation of therapy with

hematopoietic cells)

2. World Marrow Donor Association (WMDA - World

Association of Bone Marrow Donors) .

The Problem of Ownership of the Stem Cells

Collection, storage and use of donor stem cells requires the

consent of legal representative, in this case - the mother of a

newborn.

Public bank: the stem cells used for transplantation, as

required by the coincidence of the parameters of donor

cells and patient. There is no fee for the donation of cells.

Private bank: the stem cells - the property of the client, who

gets the right to dispose of them.

Benefits of Cord Blood Stem Cells

1.

ability of stem cells to divide is 8-10

times higher than that of stem cells in an

osseous adult organism;

2.

collected at birth cord blood stem

sells may be used at any

time and 100% suited to the child;

3.

procedure for collecting cord blood is

completely safe and painless.

Scientific problems of Using Stem Cells

1.

stem cells should be available in sufficient quantities;

2.

differentiation of stem cells should be

strictly directed and specific;

3.

stem cells must be viable in the body of the recipient;

4.

after transplantation stem cells should be able to integrate into

the tissue of the recipient;

5.

transplant should function throughout the life of the recipient;

6.

transplantation shouldn’t harm the recipient (including the

immune reaction of rejection).

Our expanded organ modelling targets

01.12.2011

19 - Expert meeting in Russia, Moscow -

Epidermis, Dermis, Hair follicles Skin Liver Liver-Lobulus Blood circulation

Bone multi cellular unit

Bone & Marrow

Mucosa Intestine Neuronal tissue

?

?

- Expert meeting in Russia, Moscow - 20

Living systems on a chip – state of the art

01.12.2011

Nature March 31st _{2011: Technology feature: A living system on a chip. Vol 471 pp. 661-665}

systemic multi-organ-chip concepts

Michael Shuler, Cornell University, U.S.A.

Sung J.H. et al Lab Chip 11, 389-392 (2011)

Sung J.H., Kam C.; Shuler, M.L. Lab Chip 10 446-455 (2010) Mahler G..J. et al. Biotechnol Bioeng. 104, 193-205 (2009)

Uwe Marx, Technische Universität Berlin, Germany Sonntag F. et al , J. Biotechnol 148, 70-75 (2010)

Kiichi Sato, University of Tokyo, Japan

Imura Y. et al Anal. Chem. 82, 9983-9988 (2010)

Shuichi Takayama, University of Michigan, U.S.A.

NIH launches $140M drug tox project, hunts for translational R&D chief September 20, 2011 By John Carroll

As the White House helps boost the efforts of NIH chief Francis Collins to create an ambitious new center for translational biomedical research, the agency has struck a deal with the FDA and the bleeding-edge crowd at DARPA to fund a new R&D program for the center which will create a computer chip that can better probe potential drug toxicity. The agencies will provide $140 million over 5 years to back the project for the center, which has stirred some opposition in Congress.

- Expert meeting in Russia, Moscow - 21

Hot topics for the near future

01.12.2011

 What human tissue sources are ethically and scientifically acceptable (stem cells, abortions,

donors, patients, dead body tissues …)?

 What is the maximum possible degree of emulation of a human organism (brain, heart, feelings,

like pain etc.)?

 How to use the data of humans on the chips, as they are derived from individuals with data protection

rights?

 What is the minimum genetic diversity to cope with real testing demands? How to establish broad

relevant commercial tissue banks all over the world?

 Is the maintenances of human prenatal organisms acceptable?

 What is the public perception for any of these activities in the different geographical areas?

Thank you for your attention!

Contacts:

Elena Bryzgalina

 PhD,

 Member of the committee on bioethics of the Lomonosov’s Moscow State University ,

 Head of the Department of Philosophy of Education Philosophy Faculty of Moscow State University.

Phone: +7 (495) 939 20 08

Adress: 119991, Moscow, Leninskie Gory, MSU, academic building «Shuvalovsky», 2 floor, room G359