Stem cells are unspecialized cells that can renew themselves and differentiate into other cell types. There are two main types: embryonic stem cells derived from fertilized eggs, and adult or somatic stem cells found in tissues like bone marrow. Regulations govern stem cell research and use to ensure safety and ethics. Laws like the EU Tissue Directive and UK Human Tissue Act require consent and establish standards for donation, processing, storage and research use of cells and tissues. Various codes also provide guidance on issues like characterizing cell lines, donor screening, and ensuring confidentiality. As scientific progress continues in stem cell medicine, the law aims to adapt regulations to changing circumstances.

1. PRESENTED BY: BRENDA CHONG SHI YI(00011203)
LEE ENG SHENG(00011155)
SUBJECT: EB2034
LECTURER: DR. NG
SHEE PING
Regulations Concerned
related to
Stem Cell Research

2. What is actually Stem Cell?
Unspecialized cells which have the ability of
renewing themselves through cell division.
Potential to develop and differentiate into many
different cell types with different specification in the
body in order to replace the old and damaged cell
part.

3. What types of stem cell are there?
Embryonic Stem Cells
Most embryonic stem cells are derived from embryos
that develop from eggs that have been fertilized in
vitro
Somatic Stem Cells / (Adult Stem Cell)
The origin of adult stem cells in some mature tissues
is still under investigation.

4. What are special about them?
Embryonic Stem cell
Growing cells in the laboratory is known as cell
culture.
Human embryonic stem cells (hESCs) are generated
by transferring cells from a pre implantation-stage
embryo into a culture medium.
The cells divide and spread over the surface of the
dish.

5. Somatic Stem Cell / Adult Stem Cell
Adult stem cells have been identified in many organs
and tissues, including brain, bone marrow,
peripheral blood, blood vessels, skeletal muscle.
Scientists are trying to find better ways to grow large
quantities of adult stem cells in cell culture and to
manipulate them to generate specific cell types so
they can be used to treat injury or disease.

6. PRODUCT DEVELOPMENT.
A) EU TISSUE DIRECTIVE 2004
A common regulatory framework is introduced to
ensure the safety of cells and tissues that are
transplanted into, or onto, the human body.
- On setting standards of quality and safety of the
donation, procurement, testing, processing,
preservation, storage and distribution of human
tissues and cells.
Regulation
Concerned

7. B) HUMAN TISSUE ACT (HTA) 2004
Individuals should have the right/opportunity to choose whether
tissue lawfully taken from their bodies is subsequently retained
or is used for medical research.
The Act makes it a criminal offence to use human tissue in research
without the prior consent of the individuals.
The Act also regulates tissue disposal, trafficking of controlled
materials, and DNA analysis of tissue.

8. c) Codes and Guidance
i) Tissue Related ii) UK Stem Cell Bank
• The MDA’s code includes rules
on characterizing quality, batch
control, infection controls, risk
minimization, certificates of
raw material analysis, scaffolds,
donor screening, cell culture
preparation, and full passage
data.
• Curate standardized stem cell
lines on a single site.
• House clinical-grade stem cell
lines and establish approved
facilities.
• The Draft Code covers
cryopreservation,
import/export, and
transportation of stem cell lines.

9. D) CONFIDENTIALITY AND FEEDBACK
The various codes stipulate that donors’ samples and
records should be traceable, it is likely that the
data will fall within the definitions of personal
data (under the Data Protection Act 1998) and
confidential information (at common law).

10. Conclusion
The scientific progress
associated with stem cell
medicine does not enter a
regulatory vacuum. The law is
designed to adapt to changing
social circumstance.

11. Reference
1. Genomics, Society and Policy, Vol.1 No.1 (2005) ISSN: 1746-5354
2. © CESAGen, Lancaster University, UK. http://www.gspjournal.com