bio chat
The main
regulatory
challenges
facing us is
harmonization of
guidelines on stem
cells by different
regulatory
agencies in
our country. It
becomes difficult
to follow each and
every guideline as
they are different
from each other in
several aspects
line are (a) Trichosera for
Hair application and (b)
Optisera for under eye
application. Stempeutics
is looking for strong,
strategic partner to
market these innovative
products developed from
Growth Factors/Cytokines
secreted by adult stem
cells
The third product
Stempeutics is developing
is Stempeutron™ medical
device. It is a point-of-
care, closed system,
automated medical device
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BioVoiceNews | April 2017
for the isolation of stromal
vascular fraction (SVF)
cells from human adipose
tissue for addressing the
need in the broad field of
regenerative medicine.
Stempeutron™ is the
first product to use novel
robotic and filtration
technology to isolate
clinical grade SVF from
adipose tissue. SVF has
broad clinical utility in
regenerative medicine for
repair of diseased organs
as well as in plastic and
reconstructive surgery.
The device is under
development
How do you look at the
policy and regulatory
environment in
India? What are the
challenges?
The regulatory
environment is evolving
in our country. There are
existing National Stem
Cell Guidelines by Indian
Council for Medical
Research (ICMR) and
the Guidance Document
for Regulatory Approvals
of Stem Cell and Cell
Based Products (SCCPs)
by CDSCO. Both these
documents are in the
process of revision and
we hope that the revised
document will be available
this year.
We need to appreciate
the efforts taken by DCGI
and ICMR in this area.
But the main regulatory
challenges facing us
is harmonization of
guidelines on stem cells
by different regulatory
agencies in our country.
It becomes difficult to
follow each guideline as
they are different from
each other in several
aspects. These guidelines
should be harmonized.
Also, these guidelines
should be converted
to legislation so that
unethical use of stem cells
which is prevailing in our
country can be curbed.
Other challenges in the
field are lack of trained
manpower, keeping
pace with technological
advancement and getting
funding from external
agencies in this niche area
of development.
What are the key goals
of the company in next
five years?
Our key business goals
for the next five years
includes establishing
strategic alliance with