24 July 2017 Business Stem Cell Spinoff

Cord Blood Firms Turn Astrologers

Anxiety rules expectant parents. Money-eyed and dubious firms latch on to this concern with claims of a perfect future for the child.
Cord Blood Firms Turn Astrologers
Cellugen Lab
Provides a full spectrum of stem cell solution
Photograph by Sanjay Rawat
Cord Blood Firms Turn Astrologers
outlookindia.com
2017-07-15T10:44:22+0530

The Scam So Far

  • Rs 5,000 to 1.5L charged to store stem cells up till 21 years, disposed after that age.
  • Rs 3L to 12L is the cost of stem cell therapy
  • 1:40,000 Probability of a family to use  its own stored CB
  • 21 CB banks registered with CDSCO. More than 500 unregistered
  • 500m cells can treat a person of  only 15 kg weight, which a child attains at much before 10 years
  • 5 rare diseases are curable through stem cell therapy against 80 in all claimed by private firms

***

It is a common belief that technical advancement promotes the propensity to fleece people. It’s no different in the medical field: a major upgradation in the know-how of stem cells has triggered the money-making potential of this fast-growing branch of knowledge about which most people don’t have a grasp. Thus, the ‘business’ of child birth has found a new companion in the form of private cord blood banking—something researchers and doctors say gives the provider high profits, but is low on consumer benefits.

Cord blood (CB) banking is the process of collecting blood from the umbilical cord of a newborn and storing it for future medical use. A newborn’s CB is a rich source of stem cells, which are undifferentiated cells that can give rise to infinitely more cells, thus help cure hereditary or genetic issues that can lead to blood-related diseases or even cancers.

Over the past few years, India has seen a rise in private CB banks that store the body fluid in the newborn’s umbilical cord. It comes with a fee as a promise to protect the child in the eventuality of a life-threatening disease. In 2015, the Central Drugs Standard Control Organisation (CDSCO), which is responsible for licensing and regulating CB banking in India, registered 14 such cord blood banks across the country. The number grew to 21 this year. In addition, sources tell Outlook that the country has over 500 unregistered companies dealing with CB cells and are fleecing unsuspecting consumers into spending lakhs of rupees.

Take the example of Meera Singh, a Gurgaon woman (name changed), who is expecting her first child. She was approached by one of the biggest private CB banks. Convinced by their spiel, Meera and her husband agreed to pay around Rs 75,000. So, did a scan of the foetus portend an unhealthy life or possibility of serious issues? No, reveals the couple. “The doctor has said the baby is extremely healthy, but we still want it to be safe,” says Meera. “The bank ensured us it.”

Most private CB banks promise protection from as many as 80 life-threatening diseases through stem cell transfer. Herein lies the catch: not only is the possibility of a child developing any of those diseases extremely low; the CB cells are useless in treatment in case of a disease detected.

“Most of what unregulated companies claim isn’t true. Neither are they equipped to meet such assurances.”
Geeta Jotwani, Dy D-G, ICMR

According to medical experts, the patient’s own umbilical CB cells cannot save them. For, the CB too would contain similar genetic abnormalities. Only five per cent of the 80 diseases such companies claim to cure are acquired. The rest are genetic, says Dr Anubhav Pandey, medical director of a company that provides stem cell solution. “Most diseases, contrary to what private CB banks claim, cannot be cured. For, the genetic mutation of such stem cells is not capable of creating antibodies for the disease,” says Dr Pandey, the head of the research department at CelluGen Biotech. “Those half-a-dozen or so diseases are extremely rare.”

This fact is reiterated by the Indian Council of Medical Research (ICMR) that has published research showing the effects of CB cells on several diseases. Dr Geeta Jotwani, deputy director-general of ICMR, says haematological stem cell transplantation is the lone accepted stem cell treatment for haematological malignancies and disorders. “Use of any source of stem cell for any other disorder is still experimental,” she informs.

The only situation in which private CB banks work is when there is blood needed for a family member who suffers from a disorder that requires blood cells. Even then, according to Dr V. Verma and Dr N. Tabassum, the probability of a family using its own stored CB is 1:400 to 1:200,000. And, “in case, such a circumstance arises in future, the bone marrow derived cells of a sibling could offer the same effect,” the duo says in a 2016 paper.

Yet, over the past few years, targeted advertisements by CB banks have received more traction. More and more parents are opting for the services of such private companies, which advertise generously and often follow parents at anti-natal clinics. The annual cost of services can range from between Rs 50,000 and Rs 1 lakh, according to Dr Jotwani. She also says most private banks carry out parallel businesses of offering stem cell therapy—something they are not licensed to do. Such therapies cost “between Rs 3 lakh and 12 lakh”.

This has also resulted in an increasing number of queries gynaecologists get about stem cells. Dr Suneeta Mittal of Fortis Memorial Research Institute says there is a steady increase in the number of parents opting to save their child’s umbilical cord. “Now, 40-50 per cent of all patients who come to us are opting for such private banks,” says Dr Mittal, who is the institute’s director. “Well, it is their personal choice.” Going for it is medically advisable if only the child has a sibling in need of stem cells, she adds.

Photograph by Getty Images

This is just the tip of the iceberg. To begin with, most private CB banks offer preservation services of such extracted blood only up till the first 21 years. After that age, the CB is disposed off. No stem cell can be used if there is a need of, say, a transplant later, notes Dr Pandey. This, when several of the 80 diseases private blood banks claim can cure might occur after physical maturity.

Moreover, the stem cells present in a single CB extracted at birth often falls short of the amount required to perform a comprehensive and viable transplant, according to Lalit Jaiswal, director of CelluGen. The international cut-off for storing viable stem cells is at 500 million cells per sample for it to be effective. While companies often abide by these standards, another problem persists: 500 million cells are enough to treat just a person not weighing more than 15 kg, a weight which human beings exceed even before turning 10 years old. “ After that, any patient who requires a stem cell transplant would need at least two umbilical cords to meet the required count,” says Jaiswal.

This is topped by a lack of complete knowledge about stem cells and CB cells in patients as well as doctors. A study conducted by doctors last year on awareness of umbilical CB banking in India found that the knowledge of such banks was extremely poor. The study showed that only 26.5 per cent women knew exactly what stem cell banking is while 31 per cent knew about private CB banking. Another research showed that nearly three-fifth (58 per cent) doctors were unaware about umbilical CB transplantation. Yet, as the research also showed, 40 per cent doctors were willing for umbilical CB banking for their child.

Since a single umbilical cord is not enough and one’s own umbilical cord is next to useless in treating genetic disorders, many scientists have suggested an alternate method of a public stem cell bank. It would function on the principle of a blood bank, which requires a patient to make a donation in order to be eligible for a transplant if required. Such banks, though, require at least 5,000 different samples in order to meet the diverse requirements of all donors.

Each patient needs to have an HLA (human leukocyte antigen) match in order to get a transplant, says rheumatologist-immunologist Able Lawre­nce. “This match depends on ethnicity, geography as well as other genetic factors—and is hard to find,” he notes. “That is why, we need a high number of donors for public banks.” India’s first privately-owned public blood bank was started in Tamil Nadu recently, but it has been able to accumulate only about 1,000 donors. According to ICMR, only public banking is the workable model, making it accessible and affordable.

“Half of the patients who come to us are opting for such private banks. We do not encourage any. Nor do we stop them.”
Suneeta Mittal, Director, Fortis

The union government is now making serious efforts to further regulate the private stem cell banking sector. ICMR’s Jotwani says the government’s research has brought to light several unethical practices in stem cell banking. “Several unregulated companies are carrying out unethical practices such as overcharging patients under the garb of future protection,” she says. “Most of what they claim is untrue and has no medical backing. Such banks are also offering stem cell therapy in nexus with clinicians and doctors when they are only registered as repositories.”

Understanding the concerns regarding the mismanagement by these banks based on the complaints received through different stakeholders, ICMR has taken the responsibility to frame guidance for CB banking. Only, CB banking is regulated and licensed by CDSCO. Hence, the lice­nsed CB banks are allowed to store the material they are licensed for. Many of the banks adv­ertise storing of cord tissue, placenta, menstrual blood, adipose tissue, dental pulp, etc, besides CB. Initially, these banks were established with the concept of storing CB for self-use, then shifted to sibling/family use and are now moving towards community banking.

Dr Jotwani also raises concerns over several private banks charging patients for storage of medical byproducts of umbilical cord such as placental tissue, adipose tissue and dental pulp from infants—none of which have scientific evidence of being helpful to the patient in future. “After having looked into the scientific evidence available against the use of such by-products, ICMR took a decision last year to give licenses to companies for storage of only CB. Yet several companies still continue to store other human tissues,” she says. Medically, this falls under a “grey area” since there are no laws or regulations for the storage of such matters, the expert notes. There is also no definite data available on the total number of CB cell units available in India or even the number of such transplants performed.

The 1911-formed ICMR has now constituted an expert committee to look into the matter that has come up with guidelines on the storage and use of CB cells. The ICMR, which is tasked with the formulation, coordination and promotion of biomedical research, has recently invited pertinent ministries and agencies for dialogue to curb rampant unethical stem cell practices and banking. Simultaneously, it wants a harmony of existing guidelines and regulations for better coordination and effective implementation. One of the biggest recommendations by the committee is including stem cells in the list of drugs under the Drugs and Cosmetics Act. This means the government would also have the power to not only regulate the market, but also the prices of CB banking. Other recommendations include regulations on false advertisements by companies that mislead consumers. Along with this, it aims to release a list carrying the names of diseases that can be cured through stem cells.

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