Tuesday, 26 July 2011

Biological Insurance Comes of Age in India

Biological Insurance Comes of Age in India

Umbilical cord stem cell banking, has come of age in India! And this could be just the solution to a host of diseases without the ethical concerns associated with an embryonic stem cell bank. Yes, this concept of biological insurance is slowly gaining ground in India with the recent establishment of India's private cord blood stem cell bank, 'Lifecell' launched in October last year in Chennai. With an investment of Rs.12 crore, Asia Cryo Cell Private Limited (ACCPL) is in technical collaboration with Florida based Cryo Cell International (CCI), an organization accredited by the American Association of Blood Banks and registered with the FDA. Pioneers in umbilical cord banking with a track record of over twelve years, CCI has the largest repository of banked samples.

AIIMS has marked a global first in pioneering stem cell medicine by the injection method. Doctors at New Delhi’s All India Institute of Medical Sciences (AIIMS), most recently, have used stem cell injection to treat cardiac myopathy in a baby as young as seven months old as well as on a 70 year old stroke victim, with much success! As per AIIMS studies, the benefits of stem cell injection could be extended to several delicate and crucial areas which involve severe trauma cases, brain damage and comas hitherto considered irreversible.

More than 45 disorders can be treated with stem cells from umbilical cord blood. These include various genetic disorders that affect the blood and the immune system, leukaemia and certain cancers as well as some inherited disorders of body chemistry. Cord blood stem cells have been proved to benefit a wide range of recipients including the infant donor, his/her siblings, other family members and even unrelated recipients, to varying degrees. The regenerative aspect of stem cells are particularly useful in situations when patients are diagnosed only when their disease has reached an advanced stage, explains Dr.Saranya Nandakumar, Medical Director of ‘Lifecell’.

Stem cells extracted from the umbilical cord of a new-born are simply the building blocks of life and once banked in a frozen state, at minus 196 degrees Celsius, they can be used several tens of years later, to treat ailments which this child (then an adult) may develop later due to genetic predispositions, reveals Dr.Saranya.

Once a child is born, it is the normal practice to discard the placenta and umbilical cord. But there is increasing evidence to show that this biological waste which is rich in stem cells can be used to treat a host of blood-related and life-threatening disease. Hence, expectant mothers now can make a conscious choice of whether or not to bank their newborn’s cord blood. The cord blood, collected within fifteen minutes of a baby’s birth, is processed and preserved cryogenically for a family’s potential future use. This may be done, notwithstanding the probability of its use by the family being in the range of 1 in 200 to 1 in 20,000 cases! But the underlying message is: Save a byproduct of the birth process and potentially save a life.

Umbilical cord blood is even seen as effective transplant therapy, especially in treating diseases such as leukemia, sickle cell anaemia, aplastic anaemic, various other forms of anaemia, lymphoma, neuroblastoma, retinoblastoma and several malignant and non-malignant disoders. The non-malignant diseases are primarily inherited disorders of the blood and immune systems, or diseases affecting metabolism. More recent research has identified a role for stem cells in the treatment of Parkinson’s disease, Stroke, multiple sclerosis, osteoarthritis, spinal cord injuries, cardiac disease and lupus and possibly Diabetes Type Ia and II and Alzheimer’s disease too.

ACCPL’s administrative offices and huge laboratory and storage facility are headquartered at Keelakotaiyur in the outskirts of Chennai. The company has also set up franchisee centers in Bangalore and Hyderabad and hopes to establish similar banks all over the country.

The entire collection procedure takes only 5 minutes. It involves putting a needle into the vein after ensuring sterile conditions. The blood is allowed to collect by the force of gravity into the collection bag. Once all the blood has drained out into the bag, the vein automatically collapses. Hence, the process of collection can neither be hastened nor prolonged, reveals Dr.Saranya. Also, maternal blood is collected in separate tubes for infectious disease testing.

Banking of cord blood with ACCPL is a highly streamlined process, beginning with the identification of parents desiring to bank their child’s cord blood, making them aware of the entire procedure and how it works, registering them with ACCPL, collecting the cord blood at the time of delivery in the collection kit provided by ACCPL, transporting them from the hospital or clinic in whichever city of India where the birth takes place, to ACCPL’s laboratory at Chennai through Blue Dart couriers, testing the maternal blood, processing the cord blood and finally storing it in freezers at minus 196 degrees Celsius.

Prospective parents interested in banking the cord blood, are completely briefed on the financial and technical aspects of preserving it. Once they are ready to go through with the procedure, expectant mothers go through a detailed registration process with ACCPL, best done when the women are in the second trimester of pregnancy. This allows for ACCPL to familiarize itself with the hospital where the delivery is to take place and also interact with the attending doctor, so as to coordinate things in a sound manner. A registration fee is involved at this period of time.

ACCPL maintains contact with the registered mothers through the period of their pregnancy and two month prior to the delivery date, the organization dispatches the Collection Kit with complete instructions on handling to the mother – to be. This kit is to be taken by them to the hospital when they go in to labor. The attending doctor and nurses are also adequately briefed about the contents of the kit and their use.

Each kit has its bar coded labels in duplicate, specific to each individual registration. While one set of labels are issued to the parents along with the kit, the duplicate is retained at ACCPL office. ACCPL has back up plans in place in the event that the pregnant women forget to carry the kit with them to the hospital while getting admitted for labor.

Once the registered mother goes into labour, ACCPL immediately gets in touch with couriers at the specific city or district and furnishes them details regarding the hospital from where the Kit is to be collected and the expected time of delivery of the baby. The Kit so collected should reach ACCPL laboratory within 48 hours to 72 hours of collection at the latest. ACCPL has taken every precaution to ensure that the transit temperature is maintained during transport.

Once the samples reach the laboratory, after ensuring their condition, they are processed. The amount of sample of cord blood that must be collected for a purposeful preservation, ranges between 50 – 150 ml from one single collection. The concentrate is then preserved in two aliquots of 5 ml each in two separate laboratories, one in Chennai and the other at an off site location, to safeguard against any unforeseen contingencies.

The processing involves different steps and the use of different reagents, used sequentially. The entire procedure that is followed by ACCPL is in accordance with norms laid out by CCI. Through a process of centrifugation, volume reduction of the original sample takes place, wherein the RBC and plasma is removed, thus isolating the mononuclear WBC fraction, which contains the stem cells. These cells are further treated with other reagents and finally stored in special cryovials.

ACCPL performs certain tests on every specimen of Maternal and Cord blood. Maternal blood is tested for Hepatitis B and C, HIV, Syphilis, Malaria, HTLV and CMV. Confirmatory tests will be automatically performed when required. Apart from blood counts that are vital to the whole process like WBC counts and CD 34 counts, the Cord blood sample is tested to confirm the absence of microbiological contamination.

Once processing and testing are completed, the samples are stored at minus 196 degrees Celsius, in one of two sets of freezers: one for the samples that are completely fine and the second set for what are termed as Quarantined Samples. Quarantined samples are those samples wherein the mother’s sample may be positive for any transfusion transmitted infections apart from HIV. That is, if the mother’s blood is found to be positive for any of the other viral markers or any transfusion transmitted infections that are identified by ACCPL at the time of testing, the cord cells can still be preserved to be used only for that baby or the mother herself, should the need arise later.

Clients are given a tracking number to facilitate easy identification of their sample in the future. The cord stem cells are stored for a period of 21 years by ACCPL for the parents on behalf of their children. The payment towards this storage may be made as a one-time payment or paid annually for up to 21 years by the parents after an initial sum is paid at the time of registering and processing. Once the child turns 21 years of age, the young adult should have the ability to make his or her own decisions and hence, decision on whether or not to continue further storage is decided by them based on viability studies on cord blood at that time apart from their own financial capabilities. These young adults would then continue payments for storage.

While ACCPL is a private or family cord blood bank at the moment, there are several plans to expand their activities over the next few years. Awareness of this important concept of cord blood banking is vital so that in future at least, this virtually untapped and vast resource could be put to effective use.


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