Context: Stem cell therapy is a
cutting-edge development in regenerative medicine that holds the promise of a
functional cure for Type 1 diabetes (T1D) by enabling the body to regenerate
insulin-producing beta cells. A report of a woman with
type 1 diabetes (T1D) in China who regained her insulin production made
headlines recently. She received a transplantation of reprogrammed stem cells
that reportedly “reversed” the disease. It marks a significant milestone in
diabetes management. This is the first ever successful breakthrough in
regenerating functional insulin-producing cells through stem cell therapy.

Steam
Cell Therapy

·       About: It is a form of regenerative medicine designed to repair damaged
cells within the body by reducing inflammation and modulating the immune
system.  

·       Process involved: Harvesting- The process of
collecting the stem cells to be used in the transplant, either from you or a
donor.

Conditioning- Treatment to prepare
your body for the transplant.

·       Stem
cells: These are cells from
which all other cells, with their respective specialised functions, are generated.
There are two main categories of stem cells-

Pluripotent stem cells- With the ability to
differentiate into all of the cells of the adult body.

Adult stem cells- These are tissue or
organ-specific and regenerate to form cells only of that particular organ.

·      
The challenges: Although stem cell
therapy does show positive outcomes in a controlled setting, there exist
several challenges in achieving desired results in real-world practice.
Firstly, the fact that it is an invasive procedure, and any invasive procedure
carries risks. Also, newly-transplanted cells are prone to rejection by the
body and will require long-term immune suppression that could cause infections
and cancer. Even the encapsulation technology that protects the transplanted
cells from immune rejection carries a risk in the long term.

·      
Trials and regulations
in India: Central Drugs
Standard Control Organization (CDSCO) which comes under the Ministry
of Health and Family Welfare is the main body which works on development of
regulatory procedures and standards for drugs, cosmetics, diagnostics and
devices.

Purpose: It lays down regulatory guidance by amending acts and rules; and regulates new
drug approval process.

Objective: Its main objective is
to standardize clinical research and bring safer drugs to the Indian market.

Key points

·       The
Indian perspective: In India, there are
more than 8.6 lakh people living with T1D. The costs of healthcare for a person
with T1D are far higher than for a person with the more common type 2-
diabetes. In our country, where
the demand and costs are high, treatments involving stem cells are far from
reality.

·       Way
forward: If successful, stem
cell therapy could essentially cure the disease. However, considering the cost
and, scalability; more time may be required to establish stem cell therapy as a
routine treatment for T1D.