Published in Panorama
An Untapped Resource
Provide a security blanket for your baby and family members by banking your baby’s umbilical cord blood stem cells. This is despite the probability of usage by the family being anywhere between 1 in 200 to 1 in 20000. Save a byproduct of the birth process and potentially save a life.
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.
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 says Dr Saranya Nandakumar, Medical Director of ‘Lifecell’.
It is routine to discard the placenta and umbilical cord after a baby is born, as biological waste. There is increasing evidence from various studies which reveal that stem cells from umbilical cord can be used to treat over forty five life-threatening diseases, many of them being related to blood disorders. Hence, expectant mothers and parents now have the option of saving, rather than discarding this valuable resource, immediately following the birth of their babies. Cord blood is a rich source of stem cells, which can be collected at the time of birth, processed and preserved cryogenically for a family’s potential, future use.
Blood stem cells, found mostly in bone marrow, are the factory of the blood system since they continually reproduce themselves and produce cells that make every other type of blood cell - the Oxygen carrying Red blood corpuscles (RBC), Infection-fighting White blood corpuscles (WBC) and clot-promoting platelets. Stem cells are the master cells, which are responsible for producing all the mature cells in our blood and immune system. Hence, stem cells are also the key to successful bone marrow transplantation involved in saving lives. Until recently, bone marrow was seen as the most common source of stem cells. However, studies done during the 1970s revealed that human umbilical cord blood contain the same kind of stem cells found in bone marrow. Subsequent studies and research enabled doctors to successfully transplant cord blood into a five-year-old boy suffering from Fanconi’s anaemia, for the first time in 1988, in France. Subsequently over 3500 successful cord blood transplants have been done for the treatment of various diseases.
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.
Harvesting stem cells from cord blood has certain advantages over stem cells from marrow. One of the greatest advantages of cord blood stem cell transplants is that they are available more quickly for people requiring such transplants, than bone marrow. Harvesting stem cells from bone marrow requires a surgical procedure done under anesthesia and is a tedious process that causes some discomfort. In contrast, collecting stem cells from cord blood is neither risky nor painful and can be achieved within five minutes, soon after the birth of a child. Also, a broader range of recipients may benefit from cord blood stem cells since it does not require to be perfectly matched with the recipient’s tissue proteins (Human Leukocyte Antigens - HLA) as required in bone marrow transplants. Cord blood stem cells are likely to engraft even when there are partial tissue mismatches. The risk of a serious complication – graft versus host disease (GVHD) is much less with cord blood stem cells vis-à-vis bone marrow transplant. GVHD is a condition where the donor cells attack the recipient’s tissues and the condition could be fatal. Cord blood is also less likely to contain certain infectious organisms like viruses which can in themselves pose a threat to transplant recipients.
On the flip side, the amount of cells available from the cord blood may not be sufficient to transplant in an adult patient. The target age group for cord blood transplant per se are the pediatric age group, with a body weight not exceeding 65 kg. Secondly, because this quantity is smaller, these cells once they are introduced into the recipient, have to find their way to the target organ which could be the bone marrow, brain, spinal cord, pancreas, et al. They have to find their way here,settle down there and then start multiplying. This is the whole idea in doing a stem cell transplant. This period of settling down and multiplication, termed homing and engraftment may be longer with cord blood stem cells and it therefore exposes the patient to greater risk of infection. However recent studies suggest that stem cells from the cord blood have a greater ability to generate new blood cells in comparison to those from the bone marrow, thus reducing the need for a larger number of cord blood cells to enable successful transplant.
A disadvantage of using cord blood may arise when treating a genetic disorder, as the stem cells in the cord blood would also carry the marker for the same defective gene.
What are the conditions under which cord blood would not be considered at all for collection and preservation? Dr.Saranya explains, "We have to go into a detailed maternal history when a person registers with us. If the mother herself has some serious illness for which she is on continuous medication, then we would not take the cord blood from her child. Secondly, the pregnancy itself should be normal and not fraught with problems as there might be complications either later on during pregnancy or at the time of delivery. In these situations, it is better not to confuse the issue by going in for cord blood collection. It is not as if the quality of the stem cells in these situations will be inferior, but the procedure is not done simply to avoid compounding the mother’s problems."
At what point following birth, is the cord blood collected? Dr.Saranya explains, "In a normal pregnancy when the baby is born, the cord is clamped in two places and then it is cut in between the two clamps. The baby is then removed for cleaning up and examination to see if it is perfectly normal. At that time, there is a length of the cord with the clamp on it, attached to the placenta which is still inside the mother and has not separated. The cord blood may be collected at this time or alternatively, it can be collected after the placenta comes out. The collection has to be done within 15 minutes of placental separation or else the blood will clot. This procedure can be performed with either vaginal or cesarean section deliveries.
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.