Sanghavi, chief scientific officer, RMS Regrow, Mumbai
therapies are emerging as the promising treatment now-a-days as it
helps to overcome the limitation of the existing treatment options.
Mumbai-based Regenerative Medical Services Regrow (RMS Regrow) in
partnership with a South Korean company is exploring the possibilities
of cell therapy in India.
a tete-a-tete with BioSpectrum, Satyen Sanghavi, chief scientific
officer, RMS Regrow, talks about his company's working model and
partnership with South Korea-based Sewon Cellontech. He also
shares his views on the unstructured regulatory system for stem cells
and cell therapy in India
you tell us about the genesis of RMS Regrow?
The genesis of the company goes back to the time when I was looking out
for a subject for my thesis, while I was pursuing my masters in the
UK. Back then, we had a module on stem cell technology and I
was interested in the module because it involved tissue engineering and
cell culturing. Plus, when I came back to India in 2008, there were
small talks about stem cell technology. That is when we came across a
South Korea-based company, Sewon Cellontech and we entered into a
partnership with them.
Sewon Cellontech develops technology on stem cells and was also
licensing out their technology services to various other companies. We
got the license from them for Chondron, Ossron and Babycell and as RMS
Regrow brought its services here in India. When we were working in
partnership with Sewon Cellontech, we realized that it was possible to
send the cells to South Korea for culturing and then subsequently they
send it back to us in the stipulated time period.
of the three services offered by RMS Regrow — which has a
good market uptake?
The Babycell technology which focuses on cord blood banking services,
brought to India three months back, has picked up in the market.
However, for the last one-and-a-half-year, it is Chondron, an
autologous biological therapy involving the patient’s own
cartilage tissue harvest and Ossron cell therapy, an autologous
biological therapy involving the patient’s bone marrow
harvest, which is more interesting even though Babycell has a larger
We work on a servicing model. We provide the three services to
orthopedics. So, today when a patient walks into a clinic with a knee
pain and is assessed with cartilage damage, the doctor himself may
suggest the cell therapy. He will then connect with us to culture the
cells. Then there are processes like patient consent forms, hospital
consent forms and ethics committee forms. Once we do a biopsy, the
cells have to reach the lab within two days. We then send the
cells for culturing to Korea and now to our lab in Lonavala and then
they send it back to us after culturing.
did you come up with the idea of setting up a lab in India?
When we started out with RMS Regrow, we worked out on the logistics
with our partners. Initially, it was such that there were just four of
us. I would handle the logistics and would be in close interaction with
the doctors. So, we would know exactly which hospital would start the
therapy with which doctor and then accordingly make arrangements for
sending the cells for culturing to Korea.
We had to handle operations in a very sophisticated manner because we
did not want anything to go wrong. We then started recruiting cell
engineers from reputed medical colleges. We then sent them
for training to Korea for three months and then sent another batch.
That was the time when we started constructing a lab. So in nine months
since inception of operations we took up land in Lonavala. By the time
we finished the cases in Korea, it gave a chance to each and every
surgeon we were in touch with, a case to perform and get hands-on
experience on cell therapy.
We started up the lab four months back. So the difference between
culturing cells in Korea and that in the lab in India is that
— cells sent for culturing in Korea cost
around Rs 3 lakh but at this lab it costs only
around Rs 1.5–2 lakh. We have done 8-10 cases in
our lab here. So from now on, all the cells will be cultured in this
going ahead with cell therapy on a patient, does it need to go through
any regulatory approvals?
The requirement was a few results from the initial case studies
conducted on patients. Sewon had done their human clinical trials with
successful results and since we are partners it applies to us. However,
in India, we had to go to the medical regulatory authorities and keep
them in the loop before going ahead with any case. Initially, we did
inform them several times before a case and also asked written
permission for a go ahead. But no regulatory agency in India is ready
to give the stamp for a go ahead for cell therapy because they are not
aware of the regulations and everyone is scared of giving the go ahead
in case something goes wrong in the future. Looking at the uncertainty,
today when a doctor is ready to give the treatment when conventional
treatments fail, the patient is ready and we are ready to get the cells
cultured, we go ahead with the case study. Now we have only an
independent ethics committee that comes into the picture.
trials for these services have been done in Korea. Any plans to do it
In South Korea, human trials on 800 patients were conducted. However,
in India, regulatory authorities have queries that if this works in
South Korean patients, will it work on Indian patients too and whether
safety results can be shown. So, the first 10-12 cases where we sent
cells to be cultured in South Korea was enough to show these
authorities that this works on Indian patients as well. In cell
therapy, we do not need to show a diverse patient population study. The
trials can be conducted in one country and applicable throughout out
the world. So, the regulatory authorities here need to have an open
collaboration apart from Sewon Cellontech?
Sewon is a big company and a valuable partner. They have so many
projects in the pipeline and have more than 600 people working under
them. Plus, they have business in power, agri and biotech. We already
have an established partner on their services. We are looking at
different other options and are trying to develop cells ourselves,
because collaboration brings in additional cost. Now, we have the
expertise and technicians who are well trained and have the caliber to
develop technologies on their own.
the absence of a regulatory framework a hurdle for RMS Regrow?
For stem cells, there is already a draft of guidelines but the
government is not ready for a regulatory framework. When we wanted to
start RMS Regrow, we went to all the regulatory bodies from the lower
order right up to DCGI. But they told us different things and that was
because they had less knowledge about the subject. But even now when
they do have knowledge about the processes for cell culturing there is
no separate guideline for cell therapy. The guidelines applicable for
drugs apply for cell therapy too. But there is a huge difference
between a drug and a patient cell.
there a co-relation between other businesses under the Satyan Group of
My father started Satyan Pharmaceuticals and has been running it for 25
years along with our insurance company. But there is no
co-relation between the three businesses we have right now. Satyan
Pharma is into active pharmaceutical ingredient (API) sourcing in South
Korea, Singapore and China. We are authorized agents to more than 25
manufacturers here in India. The company has around 22-25 people and
the turnover is Rs 500 crore. Then my father felt the need to move to
biotechnology because there are not many pharma drugs in the pipeline
and big pharma growth is stagnating. There is lot of biotech research
happening around the world. So as a strategic decision, RMS Regrow is a
way forward for Satyan Pharma.
does the future look like for RMS Regrow?
We are soon going to start a new therapy service for spinal chord and
this will be the use of stem cells where it is easily available. We are
expecting a turnover of Rs 10 crore by 2012. In the first year it was
Rs 1 crore so it has been quite a growth. We are also looking at
developing our own in-house R&D team without any collaboration.
It started with an acute pain on the left knee for state level (Madhya
Pradesh) cricketer, Ankit Parashar. A 21-year-old
middle order batsmen, having a budding career,
Parashar’s knee pain become unbearable and his
performance was affected when he was unable to squat while
wicket keeping. He feared that this woulde end his career. He was
diagnosed with Osteochondritis Dissecans (OCD), a joint disorder in
which cracks form in the articular cartilage and the underlying
subchondral bone. In such a condition there is no blood supply to the
Parashar then approached Dr Anant Joshi, an orthopedic surgeon with
specialization in arthroscopy, sports medicine and more famously known
to be the medical advisory to the BCCI. He then used Regenerative
Medical Services Regrow’s (RMS Regrow) new technology for
cartilage repair therapy Cartilage RMP— Chondron, a procedure
where the patient’s own cartilage tissue from the healthy
articular cartilage is collected, cultured in a lab for 4-6 weeks and
then implanted back into the defective area of the cartilage. In
Parashar’s case, after a biopsy, his cells were cultured for
six weeks in a lab in South Korea before it was sent back and implanted
in the injured area. “I am hopeful that such a technology is
the answer for many athletes who had to end their careers due to
repetitive injuries,” comments Dr Joshi. Parashar will be
back in action by next month and also hopes to make it to the Indian
National cricket team.