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At least 15 firms, including commercial ventures and research institutions, are planning to enter this space, according to the ICMR Mumbai: Regenerative medicine using human cells, a new segment in modern healthcare that has been subjected to scrutiny worldwide, from regulatory to religious, is picking up in India with at least four companies expanding their product base in the nascent market. They are Reliance Life Sciences Pvt. Ltd, LifeCell International Pvt. Ltd, Regenerative Medical Services Pvt. Ltd and Cryo-Save India Pvt. Ltd. Each of them is offering cell culture and supplying it to select specialty hospitals across India. Graphics: Ahmed Raza Khan / Mint Even though these firms have been developing this technology for the past few years, Indian hospitals have started accepting this as a treatment option only now. According to the Indian Council for Medical Research, a government agency that monitors biomedical research in India, at least 15 firms, including commercial ventures and research institutions, are planning to enter this space. Stempeutics Research Pvt. Ltd, Nichi-In Centre for Regenerative Medicine, state-owned Centre for Cellular and Molecular Biology, LV Prasad Eye Institute, Chennai, National Centre for Cell Science, Pune, and Manipal Hospital, Bangalore are some of the organizations that have reached advanced stages of clinical trials of regenerative medicines, using stem cells. Stem cell therapy, using bio-cells extracted from the same patient or biosuitable alternative human sources, targets diseases which are either incurable or with no complete or effective treatment available in the traditional healthcare system. Since this therapy is based on the concept of regenerating damaged cells in the injured or disease-affected areas of the body, it is called regenerative medicine. Tissue engineering, another regenerative medicine system for replacement of damaged skin tissues, has been in practice for burn therapy in India for the last few years.

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Page 1: stem cells R&D

At least 15 firms, including commercial ventures and research institutions, are planning to enter this space, according to the ICMR

Mumbai: Regenerative medicine using human cells, a new segment in modern healthcare that has been

subjected to scrutiny worldwide, from regulatory to religious, is picking up in India with at least four

companies expanding their product base in the nascent market.

They are Reliance Life Sciences Pvt. Ltd, LifeCell International Pvt. Ltd, Regenerative Medical Services

Pvt. Ltd and Cryo-Save India Pvt. Ltd. Each of them is offering cell culture and supplying it to select

specialty hospitals across India.

Graphics: Ahmed Raza Khan / Mint

Even though these firms have been

developing this technology for the past

few years, Indian hospitals have started

accepting this as a treatment option

only now.

According to the Indian Council for

Medical Research, a government

agency that monitors biomedical

research in India, at least 15 firms,

including commercial ventures and

research institutions, are planning to

enter this space.

Stempeutics Research Pvt. Ltd, Nichi-In Centre for Regenerative Medicine, state-owned Centre for Cellular

and Molecular Biology, LV Prasad Eye Institute, Chennai, National Centre for Cell Science, Pune, and Manipal

Hospital, Bangalore are some of the organizations that have reached advanced stages of clinical trials of

regenerative medicines, using stem cells.

Stem cell therapy, using bio-cells extracted from the same patient or biosuitable alternative human sources,

targets diseases which are either incurable or with no complete or effective treatment available in the

traditional healthcare system. Since this therapy is based on the concept of regenerating damaged cells in

the injured or disease-affected areas of the body, it is called regenerative medicine.

Tissue engineering, another regenerative medicine system for replacement of damaged skin tissues, has

been in practice for burn therapy in India for the last few years.

At least 60 clinical trials for stem cell therapies are under way currently and many more trials will start soon

with the approval of the Drug Controller General of India. The recent government decision to allow patenting

of micro-organisms and its processes, and increased awareness about cord blood cell banking are giving a

boost to the new therapy.

Page 2: stem cells R&D

Sri Ramachandra Medical College in Chennai, Kokilaben Dhirubhai Ambani Hospital and Medical Research

Institute in Mumbai and Amrutha Hospital and Research Institute in Kochi, among others, are offering stem

cell therapy.

According to K.V. Subramaniam, president and chief executive, Reliance Life Sciences, the institute is

developing a wide range of novel research-led, autologous and allogenic cell therapies and tissue-engineered

products. The company is working in the areas of embryonic stem cells, ocular stem cells, haematopoietic

stem cells and skin and tissue engineering under this initiative.

Mayur Abhaya, executive director of Chennai-based LifeCell International, said stem cell therapy is already

being used by doctors and hospitals specializing in blood cancer and other blood-related disorders as an

effective treatment solution. According to him, as new areas are emerging in stem cell therapy with the

advent of mesenchymal stem cells (that can differentiate into a variety of cell types), their potential use is

being investigated in tissue regeneration too for ailments such as diabetes, arthritis, heart stroke, spinal cord

injury and multiple sclerosis.

Besides these clinical applications, stem cells are also being used to study mechanisms of various diseases

in the human body, Abhaya said.

LifeCell is claiming to be the country’s largest stem cell solutions provider by number of clients. It is currently

involved in research, therapy, banking and clinical applications.

It offers umbilical cord blood stem cell banking and stem cell therapy solutions for patients. At least 12,000

clients have stored the umbilical cord blood stem cells of their children with LifeCell.

According to Satyen Sanghvi, chief scientific officer of Mumbai-based Regenerative Medical Services, which

brought autologous cell therapy to India in 2008 through a technology tie-up with Korea’s Sewon Cellontech

Co. Ltd, stem cells have demonstrated the ability to repair different types of tissue and offer real opportunity

to develop new treatments for various diseases.

LifeCell is planning to introduce bone marrow aspirate concentrate technology in association with Harvest

Technologies Corp. of the US. It already has a technology collaboration with Cryo-Cell International Inc. of the

US for cord blood banking.

It currently has an operational stem cell therapy centre at Sri Ramachandra Medical College in Chennai.

Abhaya said LifeCell has also initiated clinical trials with Harvest Therapeutics on critical limb ischemia, a

severe obstruction of the arteries which decreases blood flow to the hands, legs and feet. “A few more

clinical trials are being planned in other disease settings, apart from the proposed collaboration with Cryo-

Cell to launch the menstrual blood stem cell banking service in India,” he said.

Page 3: stem cells R&D

Payment Options

EMI Options

Securing your life is priceless and you wouldn't mind investing any amount to get you the best of health and

happiness. You can now invest as low as Rs.4,200 a month to protect yourself from future ailments and choose from

a range of payment plans to suite your requirement. Plan Name & Description LifeCell Femme

Plan Name & DescriptionLifeCell FemmeANNUAL STORAGE PLANCost (Rs.) Enrollment fee5,000Processing fee23,400First year storage Fee1,500Total Initial Payment29,900Annual Storage Fee / year (Upto age of 60)1,500LIFETIME STORAGE PLAN

Enrolment, processing and storage fee upto the age of 60 (No Annual Storage Fee)49,900

LifeCell Femme - Testing, processing and storage of minimally expanded menstrual blood stem cells. Expansion of

up to 150 million menstrual blood derived mesenchymal stem cells at the time of transplant.

Page 4: stem cells R&D

Payment Options

EMI Options

Femme Lifetime Storage Plan - EMI Options

Plan Name & DescriptionLifeCell Femme12 EMIEnrollment, processing and storage fee upto the age of 60 years (No Annual Storage Fee)Rs. 4, 2006 EMI

Enrollment, processing and storage fee upto the age of 60 years (No Annual Storage Fee)Rs. 8, 500

LifeCell Femme - Testing, processing and storage of minimally expanded menstrual blood stem cells. Expansion of

up to 150 million menstrual blood derived Mesenchymal Stem Cells at the time of transplant.

Stem cell banking, a Rs100-crore business in India

Cord blood storage is fast gaining momentum as a less traumatic alternative to treat neurological illnesses, and as a guarantee for the family against a host of diseases

New Delhi: Almost non-existent a few years ago in the country, stem cell banking is now a flourishing

business with more and more people wishing to store their baby’s cord blood as a form of bio-insurance,

even though it comes at a heavy price.

Cord blood storage is fast gaining momentum as a less traumatic alternative to treat neurological illnesses,

and as a guarantee for the family against a host of diseases.

Page 5: stem cells R&D

Stem cell treatment is a therapy in which new cells are injected into damaged tissues and banks generally

charge anything between Rs60,000 and Rs80,000 to harvest the cord blood for private use.

Increased awareness about the benefits of stem cell therapies has led to mushrooming of several firms

providing treatment and blood storing services in less than six years.

According to Stem Cell Global Foundation (SCGF), a Delhi-based organisation promoting research, stem cell

banking is a Rs100 crore business in India and at an annual growth of over 35%, it is expected to touch

Rs140 crore by 2010.

The overall market for stem cell research is also growing very fast and it could reach Rs2,200 crore by next

year, said Karan Goel, chairman and founder of the foundation.

“The reason behind the exceptional growth is because therapies using stem cells are giving hopes to millions

of patients afflicted with chronic diseases and not responding to conventional treatment,” Goel said.

According to Goel, ”Market growth estimates for other Asian countries, except China, are less than that for

India.”

While there are currently seven institutes which provide the cord blood storing facilities, over 15 institutes

are involved in research and therapy.

LifeCell, the first such organisation to bring this concept to India, claimed that about 20,000 parents have so

far banked their baby’s cord blood stem cells with it.

Cyrobanks India, another major player, said to have gathered more 15,000 clients since it made an entry in

the country four years ago.

“It’s a growing field and we are confident with the growing awareness, more and more people will come

forward to store their baby’s cord blood,” said Asim Ghazi, a spokesperson for Cyrobanks India.

According to health experts, the stem cells collected from the cord blood of a newborn are very rich that can

differentiate into blood and immune system as well as heart, brain, spinal and pancreatic tissues.

“These stem cells have the power to regenerate, repair or replace damaged cells in the body,” said Dr Sonia

Naik at Sitaram Bharatia Institute of Science and Research, New Delhi.

“It is like an assurance for the child and its family members,” she said, adding a child’s stem cells have a

25% chance to match for a sibling.

Dr Anoop Mishra, head of diabetes and metabolic diseases, Fortis Hospitals, said stem cells are also ideal for

treating genetically inherited disorders of metabolism.

”If you have a family history or are worried about a predisposition to certain diseases, cord blood banking

could be your ray of hope,“ said Mishra, who recently undertook a clinical trial using stem cells to cure

diabetic foot.

Page 6: stem cells R&D

Globally, stem cells are used to treat over 130 diseases and it is estimated that more than 500 clinical trials

are being done to develop therapies using stem cells.

“The cells can be used in allogenic or autologous transplant for Haematopoietic regeneration in diseases like

thalassemia, leukemia, cancers and many more,” Dr Naik said.

However, people are little skeptical about procedure being adopted by the laboratories to store the cord

blood as there were no regulatory norms.

But allying such fears, Ghazi of Cyrobanks said banks adopt highly advanced technology in preserving the

placenta umbilical cord after the baby is delivered and the cord cut.

“This blood is sent to a bank where it is processed and preserved by freezing them in liquid nitrogen at a

temperature of -196 degrees Celsius,” he said, adding through the procedure blood can be safely stored for

600 years.

However, these facilities come at a very heavy price.

“There is a fee for service in case of private donation as the cord blood product is owned by the mother. In

case of public donation the parents do not incur any charges,” said Ghazi, adding that with increasing

number of clients, the fees will also go down.

Government sets up panel to regulate use of stem cells

The panel is being formed parallel to the existing investigational new drug committee, which gives mandatory approvals for clinical trials of new drug candidates in India

New Delhi: Those seeking to store their children’s stem cells or start therapy using them will soon be able to

use government-approved facilities for their storage and use.

Currently, there are no regulations governing stem cells, which are so-called master cells that have the

ability to renew themselves and differentiating into a wide range of specialized cell types. The health

ministry has approved and notified a committee to look at therapies related to stem cells and genes.

The 11-member committee will be headed by V.M. Katoch, secretary, department of health research, and

director-general of the Indian Council of Medical Research (ICMR). The drug controller general of India is also

one of the members.

Page 7: stem cells R&D

Mint had reported in November that senior officials at the ministry were putting together a proposal to form

an expert committee for stem cell banks and related therapies. In June, the ministry had also put up for

public consultation draft rules for umbilical cord blood banking. The move towards some degree of regulation

on the completely unregulated area of therapies that use stem cells, living cells and genes for treatment is

seen as a step in the right direction by industry watchers.

“Any therapeutic product that is preserved for some time and then used for treatment is a manipulated

product and can lead to death. Therapeutic products derived from stem cells, genes, xenotransplants... all

fall under this category, and hence, need some regulation to their use. This is an attempt to bring that into

effect,” said an official at the ministry of health on condition of anonymity.

The panel is being formed parallel to the existing investigational new drug committee, which gives

mandatory approvals for clinical trials of new drug candidates in India. The stem cell committee’s approvals

will not be mandatory for the time being but will become compulsory once the regulatory framework is in

place.

“The committee will work in tandem with the draft rules that have been prepared for the same purpose and

will look to enhance them later as well,” said another health ministry official. He did not want to be identified.

ICMR and the department of biotechnology had laid down guidelines for stem cell research and therapy in

2007, but in the absence of laws specific to the issue, they do not carry much weight.

“Cord blood banks do not have a licence scheme to go through. This is necessary in order to increase

confidence in India about stem cell banking. A lot of clients need stem cell therapy, which is expensive and

we don’t want these clients to be cheated by a sham set-up. So, we believe regulation is important for a

developing field like this,” said Mayur Abhaya, executive director, LifeCell. The company has investments

worth Rs. 30 crore in India in the stem cell banking industry. A typical stem cell storage facility costs Rs.

36,000 for collection, processing and testing and charges an annual storage fee of Rs. 2,000 for per annum.

Over the past few years, India has seen a surge in the stem cell business. Apart from several foreign

companies, the industry has witnessed the mushrooming of small domestic firms. According to industry

estimates, the domestic market size is Rs. 100 crore now and growing at an annual pace of 40%.

Page 8: stem cells R&D

On Stem Cell Banks: C V Nerikar, Cryobanks International India

Tuesday, 01 June 2010 00:00 DARE Opportunities - Health & Wellness

What should one consider closely while planning to start a stem cell bank?One of the things that is critical in a stem cell banking operation is understanding what segment of banking you want to be in. One goes into the public domain and the other goes into private domain.

You can also have a hybrid model too. Which model you follow will decide on this aspect. The second thing is what product you want to bank. This will decide who your target customer will be. You may have umbilical cord banking, adipose tissue banking, tooth banking etc. Tooth is also a very good source of stem cells. Depending on what exactly you are looking to bank, your business proposition changes. For eg: you say you want to open a fat stem cell bank, then your segment of population is further reduced. How many people do you know in your immediate circle who want to go for liposuction. So your segment becomes very restricted. So your price proposition, your proposition of how you present the whole thing across, changes all together.

 

Based on what you wish to bank, your infrastructure is linked. So if you wish to bank umbical, there is a particular set of instrumentation etc. There is a difference of instrumentation, difference in technology and infrastructure which come into play for different types of banks.

What are the key challenges one comes across?Right Awareness: Awareness is the first thing. In the West there are very strong public banks available. So a guy when he requires it, he can rely on this When a part of this company was started, cord blood banking was an expensive proposition. It was considered that only a particular strata of the society can think of this. The reason is that Rs 70,000 is no joke. Our effort was to make it easier for our customers to go in for this banking. So we brought in an EMI scheme, making it cheaper for everyone to avoid it. Every parent should have the right to bank, provided they believe in it. And I don't want them to believe in it without actually having understood the concept. I want it to be a thought through evaluated decision rather than just a spontaneous decision. So our thinking was how can I make it easy. So we brought down this price barrier from Rs 70,000 to Rs 3,400.

Right Set of People: This is a very people-driven business. This is because it is a concept that people need to understand. As humans we like social touch. Actually there is no availability of trained manpower. There is a huge shortage of right kind of people. This is because the industry is very nascent.

Page 9: stem cells R&D

Slow Growing Business: This business requires a lot of funds. It has comparatively a longer gestation than most other businesses. Once it reaches a critical mass, it has a snowball effect. But you have to wait. It may take one year or 20 years. This depends on how you strategize, how you market and various other aspects.

How does your EMI scheme works?I look it from middle class perspective. When a baby is born, the parents have to bear so many expenses. There is meternity costs, socio-religious costs, costs on of medicines etc and then you are talking of cord blood. You have suddenly loaded the person with extra cost. The guy may want to go in for EMI scheme: Rs 3,400 over a period of 25 months. This splits over a period of time. We haven't come across too many defaulters. If there have been any defaulters, it has been because they felt it was not the right decision to take. This scheme is largely driven by us. We are in the process of linking up with some banks. So we believe that it will take things forward.

What is the market size?India is about 26 million births, and all these are potential customers. Even if 10% go in for this banking, the potential is huge. There is a lot of scope for someone to walk into the business.

How does one start a stem cell banking business?There is significant capital outlay in terms of setting up a bank but there is even more expense in terms of running the business. My thumb rule understanding is 1:5. There is longer gestation periods, lots of advertising and marketing, awareness driven activities are needed. A lot of awareness can be done by successes coming out of it.

What is the risk in this business?The biggest threat is that if tomorrow it comes out that the product is not needed. That is the only risk I see. Say tomorrow a research says you don't need to bank your stem cells, we can create enough of them from your hair follicle. Then the industry is going to get affected. Then there are liability issues. We are an insured company. We are the only company in India which is insured in this business. Second is the risk of regulations. Tomorrow, you have mom-and-pop banks coming up in every city. Here we are sitting with a Rs 30-40 crore investment, naturally my costs will be higher. There has to be some standard guidelines, some licensing procedure. As of now there is something but it is not stringent enough. So we get global accreditaions, we work on those models. There are also some ethical and religious issues.

What is the cost of setting up this business?Most equipments are imported. Rooms have to be fully access controlled, highly secured with all state-of-the-art facility. If you have land or building, the cost would be Rs 20-25 crore. Cost of running, depends on how you run it.

When we entered this market, people were using vials for storage. It was an open storage system. Vials have a problem of contamination. Vials have a problem of contamination. When we came we brought in something known as closed bag system. We can store more than 1.5 lakh cells.

Page 10: stem cells R&D

Private Cord Blood Banks in India

Babycell IndiaINTERNET: babycell.inPHONE: 1-800-209-0309 toll free OFFICE: Mumbai, IndiaSTORAGE: Pune, Maharashta, India

COMMENTS: Babycell.in and Regrow.in (Regenerative Medical Services Pvt. Ltd.) are both based on technology transfer from the first family cord blood bank in South Korea, Sewon Cellontech, also known as BabyCell.

SERVICES & OPTIONS: Babycell India operates in these centres: Pune, Hyderabad, Delhi and Mumbai, Nagpur &

Aurangabad. Babycell offers a laboratory tour to enrolled clients. Babycell India collects by gravity drip into blood bags.  Collection may be before or after the

delivery of the placenta. Babycell India contract includes shipping from anywhere in India.  The shipping container has

gel packs to maintain temperature stability, which is recorded with a temperature logger. Shipping is provided by a sub-contract to a courier service with a division specializing in

transport of biological samples. Babycell technicians process cord blood manually by sedimentation. Final storage is in blood bags with two compartments.  Each bag is held in a metal canister. Babycell storage freezer uses the vapor phase of liquid nitrogen. Discounts available for medical professionals. Clients are offered 3 pricing plans. Babycell India offers a Philanthropy Program: a payment of Rs 500,000 is made if the baby

needs its own cord blood for a proven treatment, or a payment of Rs 250,000 is made if the parents or sibling require a transplant of the baby's cells.

Babycell India also offers classes to expectant mothers in nutrition and exercise.

ADDITIONAL INFORMATION:Babycell and Regenerative Medical Services Pvt. Ltd. are self-funded companies, only the technology transfer comes from the South Korean biotech company Sewon Cellontech (Babycell).

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CordLife Sciences (India) Private Limited

Page 11: stem cells R&D

INTERNET: www.cordlifeindia.comPHONE: 91-33-2489565 (mobile 98301 66200) or [email protected]: Kolkata, West Bengal, India.STORAGE: Kolkata, West Bengal, India.

COMMENTS: CordLife originated in Singapore and now operates the most extensive network of multi-national cord blood banks in Asia.

SERVICES & OPTIONS: CordLife India is the only bank in West Bengal licensed by the Ministry of Health (Drugs

Controller of India - DCGI). CordLife India collects in blood bags. CordLife India contract does not include courier service. CordLife technicians will process cord blood manually: Final storage will be is in blood bags in the vapour phase of liquid nitrogen. CordLife India processing fee includes first year storage. Payment plans available, discounts for pre-paid long-term storage. Discounts to clients who are medical professionals. CordLife is a founding member of the Asia Pacific Cord Blood Bank Consortium

ADDITIONAL INFORMATION:

See the description of CordLife in Singapore for the full company history.

CordLife Sciences (India) Private Limited was formed on 20 Jan 2006 as an equity partnership between the Singapore-based cord blood bank CordLife, and the Kolkata-based biotech company Strassenburg Pharmaceuticals.  Strassenburg Pharmaceuticals was established in 1987 and already has a GMP-compliant laboratory in Kolkata.  The Managing Director of Strassenburg Pharmaceuticals, Mr. Deepnath Roy Chowdhury, is also VP of the Indian Drug Manufacturer's Association for Eastern India.

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Cryobanks International IndiaINTERNET: www.cryobanksindia.comPHONE: 1-800-180-1217 or 1-8-00-102-2796 or [email protected] + STORAGE: Gurgaon (Haryana), India.

COMMENTS: Cryobanks India has about 20 offices serving Pan India, Sri Lanka, Bangladesh, Nepal, and the Middle East.

SERVICES & OPTIONS: The laboratory operates continuously to process cord blood as it arrives. Cryobanks India is housed in a concrete building with continuous monitoring, electrical back-

ups, sprinklers, and alarms. Licensed under the Drugs and Cosmetics Act, Govt. of India (DCGI) Cryobanks India uses a closed-bag collection system where the anticoagulant is already in the

bag, to minimize possible contamination.

Page 12: stem cells R&D

Courier service can be arranged through Cryobanks India for an extra fee. Laboratory technicians manually separated MonoNuclearCells using the chemical Hespan,

following the procedure developed at the NY Blood Center. Final storage is in blood bags with portions of 20 and 5 ml, plus 3 integrally attached aliquots for

testing. Flexible payment options are available. Cryobanks India claims their inventory, as of Nov 2008, is about 4000 collections.

ADDITIONAL INFORMATION:

Cryobanks International India is a joint venture between Cryobanks International USA and RJ Corp founded in 2006.  The RJ Corp is Rs. 3000 crore diversified conglomerate with interests in Beverages, Fast Foods, Dairy products, Retail, Real Estate, Housing, and Healthcare & Education, in India and overseas. Started in 1991, the RJ Corp is headed by Mr. R. K. Jaipuria. The Group's vision - to excel in everything we touch and handle - is visible in their many charitable and pioneering initiatives.

Cryobanks India is headed by cardiac surgeon Dr. Naresh Trehan and based in North India at Gurgaon Haryana.  Cryobanks India will have special focus on research of stem cell therapies as a potential treatment for cardiac diseases and diabetes.  The objective of Cryobanks India is to offer both family storage and public donation across India, covering all ethnic groups in India.

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Cryo-Save (India) Pvt. Ltd.INTERNET: www.cryo-save.com/inPHONE: +91 80 42430100 or 1800 1030100OFFICE: Bangalore, India.STORAGE:  India

COMMENTS:

SERVICES & OPTIONS: Cryo-Save India has branch offices in 7 cities. Cryo-Save India is the only cord blood company in India which operates a fully automated

laboratory processing system.  The benefits of this system are much lower chances of contamination during processing.

Cryo-Save India is the youngest stem cell company in India to achieve ISO 9001:2008 certification.

The tissue of the umbilical cord, called Wharton's Jelly, is also saved for future use.

ADDITIONAL INFORMATION:

Cryo-Save is a multi-national cord blood banking company with operations in 39 countries (June 2010).  The headquarters and lab for Cryo-Save Europe are in Niel, Belgium, where they hold the largest cord blood inventory of any bank in Europe.  The Managing Director of Cryo-Save India is Chandra Mouli.  Cryo-Save India plans to introduce additional stem cell services, such as the storage of stem cells harvested from fatty tissue in adults.

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Page 13: stem cells R&D

International Stemcell Services Ltd.INTERNET: www.internationalstemcellservices.comPHONE: +91-(80)-6565 2220 or Helpline +91-9916964460OFFICE: Bangalore, India.STORAGE:  India.

COMMENTS: International Stem Cell Services Ltd. (ISSL) has been offering cord blood banking since 2003.  Their aim is to provide affordable adult stem cell treatment options for patients world-wide.

CORD BLOOD BANKING SERVICES: As of spring 2010, satellite offices are located in Delhi, Goa, Jabalpur, Lucknow, Mumbai,

Thanjavur Stem cells are processed in cGMP compliant laboratory conditions. Included in laboratory tests are CD34+ counts and CFU-GM viability assay, which typically are

only performed by public cord blood banks. Discounts to clients who are medical professionals.

ADDITIONAL STEM CELL BANKING SERVICES: Stem cells from the tissue of the umbilical cord, called "Wharton's Jelly".  This structure is rich in

mesenchymal stem cells which can differentiate into bone, muscles, and skin. Stem cells mobilized from peripheral blood. Stem cells from marrow. Stem cells aspirated from fat. ISSL offers stem cell expansion in their laboratory.

ADDITIONAL INFORMATION:

The founder Dr. S.G.A. Rao is the former head of the Dept. of Chemotherapy and Stem Cell Biology at the Cancer Research Institute, Tata Memorial Centre, Mumbai.  He established India's first cord blood stem cell bank in 2003.  The website lists the board of directors and the Scientific Advisory Board.  ISSL cooperates with specialty hospitals to offer adults stem cell therapy with their own cells.  Currently they are participating in several clinical trials.

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LifeCell IndiaINTERNET: www.lifecellinternational.com PHONE: 800-425-5323OFFICE: Chennai, IndiaSTORAGE: Chennai, India

COMMENT: LifeCell was the first private cord blood bank in India, which has a birth rate of 25 million per year, and the first to be accredited by AABB.

SERVICES & DISCOUNT OPTIONS: 

Page 14: stem cells R&D

Technologies licensed by Cryo-Cell International, operations begun in March 2005. LifeCell claims to have the largest network in India, with over 50 birth centers.

ADDITIONAL INFORMATION:

LifeCell is owned by Asia Cryo-Cell Private Limited (ACCPL), a private company formed 6Oct2004.  The start-up funding was guaranteed by Abusha Investment & Management Services Private Limited. The CEO of the new company is also a large stakeholder in Shasun Chemicals and Drugs Limited, a $60 million Indian company that is the world’s largest manufacturer of ibuprofen.  LifeCell Board of Directors and Advisory Board are listed on-line.  Lifecell has invested Rs 15 crore to set up a 16,000-sq.ft laboratory at Keelakottiyur in the suburbs of Chennai.

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Nanog India Pvt. Ltd.INTERNET: www.nanogindia.comPHONE: 020 32240 6366OFFICE: Pune, Maharashta, IndiaSTORAGE: StemOne Biologicals in Pune, India; BioVault in Plymouth, UK

COMMENT: Nanog India is the only cord blood bank in India that follows the European business model, where one company specializes in education, training, and logistics, and a partner company specializes in laboratory and storage services.  Nanog India offers clients either storage in India or abroad, a choice that is appealing to expatriates and non-resident Indians.

SERVICES & OPTIONS: In India, the Nanog partner lab is StemOne Biologicals, located in Pune.  Their new lab is one of

the largest stem cell facilities in the country.  In Europe, the Nanog partner lab is BioVault, located in the UK.  They are the public cord blood

bank for the National Health Service and offer contract services to private cord blood storage companies. 

Nanog International is ISO 9001:2000 certified for procurement , information, commercial and logistical services for cord blood banking.

Nanog charges an Enrollment fee of 5000 Rs. to cover initial registration and the collection kit, that is not refundable. 

The Nanog India price includes courier service to its lab, and full transport and retrieval services if and when the cord blood is required for therapeutic treatment.

The Nanog partner lab tests for the stem cell marker CD34+ that is used by transplant centres.  Nanog offers HLA typing for an additional fee of .... Nanog India holds final storage in a Pall blood bag with two portions holding 80%/20% volume. Nanog India cryogenic storage is in the vapour phase of liquid nitrogen. After processing, Nanog issues a certificate giving parents the stem cell counts of their child’s

blood. In the event of a poor cell count, either quantitively or qualitively, Nanog offers families the right

to withdraw their blood unit from storage with a refund of all storage fees, minus the cost of lab processing costs.

Nanog India offers both 21 and 25 years storage.

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ADDITIONAL INFORMATION:

The parent company of Nanog India, Nanog International, began as SmartBank in Italy in 2005.  While SmartBank continues to be the company’s brand name in Italy, the international brand name is Nanog.  The Nanog protein enables stem cells to both replicate and differentiate at the same time.  In effect, the Nanog protein makes cells forever young, hence it is named after a Scottish legend of the land of the forever young.

The founder and Scientific Director of Nanog is Dr. Irene Martini, a cellular biologist with many years of research experience.  Dr. Martini has worked on EU and WHO research projects, writes for a number of scientific journals, and is a regular speaker at international stem cell conferences. 

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Reliance Life Sciences Pvt. Ltd.INTERNET: www.rellife.com/PHONE: + 91 (22) 6767 8000 OFFICE: Dhirubhai Ambani Life Sciences Center, Mumbai, India

COMMENT: Reliance established South Asia's first cord blood repository offering both public donation and family storage.

CORD BLOOD BANKING SERVICES:Reliance Life Sciences laboratory has been inspected & accredited by AABB

CORD TISSUE BANKING SERVICES: Reliance offers two options in cord tissue banking:ReliCord®: cord blood +1 million cord tissue stem cells, or  ReliCord® - M50: cord blood + 50 million cord tissue stem cells.

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StemCyte India Therapeutics Pvt. Ltd. INTERNET: www.stemcyteindia.comPHONE: 079-6170 1001, toll free 1-860-4204206OFFICE: Ahmedabad, IndiaSTORAGE:  Apollo Hospital Campus, Gujarat, India

COMMENTS: StemCyte India aims to build a for-profit bank that collects both public and private cord blood, like the other branches of StemCyte in the USA and Taiwan.

SERVICES & OPTIONS:

ADDITIONAL INFORMATION:

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StemCyte India Therapeutics Pvt. Ltd. is a joint venture between StemCyte Inc. (USA), Apollo Hospital Enterprises Ltd. and Cadila Pharmaceuticals Ltd.  StemCyte India has signed an MOU in Vibrant Gujarat Summit – 2007, in presence of Hon. Chief Minister Shri. Narendrabhai Modi, and is headquartered in Ahmedabad.

StemOne Biologicals Pvt. Ltd.INTERNET: www.stemone.co.in Email [email protected]: Admin. Office: +91 20 2545 1509, Corp. Office: +91 20 3233 3005, Mobile:+91 98 6007 6609OFFICE & STORAGE: Pune, Maharashta, India

COMMENT: StemOne Biologicals (S1B) has one of the largest stem cell facilities in India.  They offer the entire spectrum of stem cell related services, from collection and processing through treatment at partner clinics.  Their slogan is: "We not only store but endeavour to cure."

SERVICES & OPTIONS: S1B is a multi-source stem cell cryopreservation facility.  They store stem cells from: 1. umbilical cord blood2. peripheral blood 3. bone marrow S1B has been inspected and accorded a license by the Indian authority, Central Drugs Standard

Control Organization (CDSCO), for its cord blood bank facility. S1B has also been inspected an accredited by the international quality standard ISO 9001:2008 The S1B kits provide bags to collect cord blood by gravity, prior to delivery of the placenta. S1B uses a shipping container holding gel packs for temperature stability. The laboratory is staffed by technicians working 24/7.  S1B technicians manually remove red cells and plasma to reduce blood volume and then store

the remaining "buffy coat" layer that contains white cells and stem cells. S1B final storage in blood bags, with two compartments of 20 & 5 ml, plus integrally attached

testing segments. S1B cryogenic storage is in the vapour phase of liquid nitrogen. Cost includes shipping of the cord blood to the laboratory within 24 hours. First year storage included in processing fee. Payment plans available, discount for 20 years of pre-paid storage Discount for clients who are medical professionals. In case of need, there is no charge to ship the cord blood within Maharashta. As of Dec. 2010, S1B claims an inventory of more than 1500 cord blood collections. Between Mar. 2009 and Aug. 2010, S1B provided cord blood to treat 6 children for Cerebral

Palsy: 3 with their own cord blood (autologous) and 3 with sibling cord blood (related allogeneic).

S1B is the only company from India that is a member of the Asia Pacific Cord Blood Bank Consortium

ADDITIONAL INFORMATION:StemOne Biologicals Private Limited (S1B) was formerly known as Cord Life Biotech Pvt Ltd.  They incorporated on 17 June 2005 and started lab operations in April 2006.  The founding CEO and Managing Director of S1B is Chaitanya Purandare, a Medical Geneticist and entrepreneur who received his training in the UK.  In 2010, S1B built a new suite of stem cell labs including 6 clean rooms of  10,000 and 2500 square feet of storage area.  The new facility will be fully operational in March 2011 and hopes to achieve FACT JACIE accreditation.  As of the end of 2010, India does not yet have any

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legislation governing cord blood banks.

In 2010, StemOne Biologicals was a Gold Sponsor for the India Stem Cell Conclave & Exhibition.  In that year, S1B also launched new strategic with Nanog Intnl. of Italy.  Nanog India will manage education and outreach services for cord blood banking in the laboratory of StemOne Biologicals. 

As well as operating a multi-source processing and storage facility, StemOne Biologicals has expanded its  operations into cell based therapies with an ambitious Research and Development program.  S1B is a pioneer in stem cell based therapies for a range of conditions including Cerebral palsy, Spinal Cord Injuries, Stroke, Cardiac disease, Wound healing and Skin regeneration.  S1B has also formed a partnership with Bionet Corp. of Taiwan to exchange technologies in the therapy arena.  S1B has a specialized team of 20 clinicians who work to provide therapy for patients with various disorders.

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Last modified: 09.March 2011Copyright 2000 - 2011 Frances Verter

Preserving lives in banks!

Friday, 01 April 2011 12:25 DARE Opportunities - Health & Wellness

Stem cell banking, a space currently predominated by MNCs, holds immense scope for domestic players ready to exploit the growing opportunity

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Currently a US$ 2 billion market in India, and projected to be a US$ 5 billion market in the next five years, the life-giving stem cell industry is only partially exploited so far. Much remains to be seen while players make up their minds to capitalise on the opportunity.

Growing at a considerable speed, the stem cell industry can, however, witness a magnificent acceleration in its growth with more SME (Small and Medium Enterprises) entrepreneurs taking the plunge. Stem cell banking has huge scope in India.  The country currently records 25 million births every year while only a pitiful 10,000 cord bloods are banked.

Stem Cell BankingStem cell bank is a facility that preserves stem cell, a specialised cell in the body that is capable of regenerating and turning into tissues, organs and systems in the human body, for future use.

Due to their ability to replace damaged cells in the body, they can be used to treat a range of conditions including heart failure, cancer, spinal injuries, diabetes, Parkinson disease, and many more.

There are various sources in the body from where stem cells can be procured. At the time of childbirth stem cells could be extracted from amniotic membrane, placenta, cord, cord blood, etc. Later it can be extracted from bone marrow and dental pulp.

However, since cord blood, obtained from umbilical cord, is the purest form of stem cell with high potential to differentiate into specialised cell types, the trend of storing them at the time of childbirth is on the rise. Lest other sources get infected and are rendered useless in the event of some disease, parents are increasingly considering the option of storing cord blood at the time of childbirth despite the high cost that it involves.

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Verticals of The SectorThere are three verticals in stem cells— cord blood banking, application and pure R&D (reasearch and development). While all of these offer ample scope, cord blood banking is the most popular. The reason being entrepreneurs without relevant background and much technical knowhow can as well enter the industry and reap benefits while the other verticals require specialised knowledge.

Lately, however, the practice of dental stem cell banking has picked up some pace in India. But it isn’t as popular as cord blood for reason such as— a.) the amount of dental pulp is insufficient to be used for curing any disease b.) the science behind its use hasn’t been established so far. Giving an example Chaitanya Purandare, Chairman and Managing Director, StemOne, says,”If you are going on a long hike would you carry a small bottle of water or a big one that you know will last you till the end-- you would probably go for the latter. Similar is the difference between cord blood banking or application using bone marrow against dental pulp.”

Segments of BankingAnyone contemplating starting a stem cell bank has two options: public and private banking. Public banking is, however, off limits for any entrepreneur unless he has extremely deep pockets. Purandare says, “An entrepreneur not interested in seeing results in his life-time can consider this option.”

World over public banking is done by government or government sponsored institutions. In fact, very few private banks engage in public banking primarily because the usage of donated cord blood is not much right now and secondly to keep cord blood for the Indian population, from the point of view of genetic diversity, one will have to keep stock of a lot of cord blood and hold on to it until it is used. That would mean running a humongous inventory without knowing when it is going to be used.

Requisites of The BusinessTo start a stem cell bank, an entrepreneur, besides a keen interest and long term vision, must have the technical knowhow of the business. He should have a biology based background to understand the scientific basis of the business, but in case he doesn’t have a relevant background, he should employ a team which has a strong technical background. Alternatively, he can tie-up with an international brand to get the international knowhow on how to start a stem cell bank.

Purandare says, “Starting a cord blood bank is not something that you can read up a book and do. There are certain protocols of the business which not everyone know and the ones who know may not give theirs.” It is important to have the technical knowhow to know how to process a cord blood sample when received.

“Starting a cord blood bank is not something that you can read up a book and do. There are certain protocols of the business which not everyone know and the ones who know may not give theirs”

- Chaitanya PurandareCMD, StemOne

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Additionally, the business, like any other, requires investments. Stem cell banking requires around `10-15 crores as initial investment. The investment encompasses expenditures on acquiring land, equipments, building, manpower, etc. The business also requires a good sum of amount to pay for its operational expenses.

Apart from capital and the technical knowhow, it is important for one, contemplating to enter the industry, to understand the market. Market surveys could come in handy to understand the dynamics of the market one is targeting.

Need to MarketAn entrepreneur should see that his services are well marketed. Since stem cell banking is a specialised subject, not everyone is aware of it. While people from educated backgrounds find it easier to understand the concept, many find it difficult to see the use of storing their children’s cord blood for years not knowing when they might be required or whether they would be required at all.

Dr Kedar Gadgil, Director, StoreYourCells, says, “Stem cell banks need to educate doctors who in turn will educate and offer the service to their patients.”

Break-even PeriodNo denying that the business has bright prospects, but the gestation period in this business could be longer. However, one can probably break-even in three to five years depending upon how much amount is invested, where one is placed and other variable factors.

Possible RisksOne of the biggest risks of this business could be deferred break-even. Among the other risks, one could be the possibility of being taken over by a bigger brand in the market. However, Purandare says, “If you are coming in with `10-15 crore, I don’t see a reason why would you not be able to take a decent share in a market of a country that records 25 million births a year.”

According to him there is a huge market out there waiting to be exploited, however, the entrant must come in with the right frame of mind. He says, “This is a long haul game. People are here for 21 years and you can’t walk out of it after 3 years.”

How to make it bigTo make it big here, one must refrain from getting stuck in a zone. Stem cell is evolving constantly. Every six months there is something new happening in stem cells. Therefore, one has to be flexible enough to move from one vertical to another. And to be flexible it is important to keep yourself updated with the changes in the market and have a long term vision.

“Stem cell banks need to educate doctors who in turn

will educate and offer the service to their patients.”- Dr Kedar Gadgil, Director

Stem cells in human body

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