RAJESH JHORAWAT Vs. LIFE CELL INTERNATIONAL PVT. LTD.

JUDGEMENT

(1.) The use of stem cells in the treatment of several diseases such as Thalassemia, Leukaemia, Lymphoma and auto-immune disorders, is being increasingly recognized. Bone-Marrow transplantation is being currently used for treatment of several diseases, including certain malignancies and genetic blood disorders. If it is not possible to get bone marrow donor from a family member, attempt is made to find a suitably HLA matched donor for the patients needing stem cells transplant. It is not always possible to find suitable donors. Moreover, GVHD (Graft- Versus-Host-Disease) occurs in majority of bone-marrows coming from outside the family of the patient. The cord blood which is the left over blood in the umbilical cord and placenta after the birth of a child, is seen as comparable to the bone-marrow in terms of its utility in stem cell transplantation and in fact offers a number of advantages over the bone-marrow. It has also been found that the related samples instead of unrelated samples dramatically increase the survival rate for the patients.

(2.) For the purpose of collecting the cord blood and cord tissue, a sample of the blood is taken immediately after the birth of the child, once the placenta and the umbilical cord are safely delivered. The shorter the time between the birth of the child and cryo-preserver, the better it is for the quality of the cord blood and tissue. Once the stem cells are frozen and are stored in a bank, they can remain stored for upto 25 years, provided that they have been suitably processed and stored. It is therefore, necessary to take the sample of the blood and the cord without any delay once the child is born and an un-expectable delay in drawing such samples is likely to render the sample incapable of being analysed and stored for future.

(3.) The opposite party, namely Life Cell International Pvt. Ltd., is engaged in collection and preservation of the umbilical cord blood and tissue of a baby and as per the Brochure issued by the opposite party, the collection of umbilical cord stem cell can be done only at the time of birth. On the parents signing up with the opposite party for such collection and preservation, a collection kit is provided to them with necessary tools and instruments in sterile condition for the collection of the umbilical cord blood, cord tissue and maternal blood samples. It is also stated in the Brochure issued by the opposite party that the umbilical cord blood and maternal blood sample are collected just after child birth (emphasis supplied). The sample is transported to the laboratory of the opposite party within 48 hours and the opposite party claims to have enabled online tracking of the sample right from the time it leaves the hospital, in order to allow the parents to track the journey of the stem cells of the baby, right from the umbilical cord, to the cryo-presever. In the laboratory the sample is subjected to various tests to check for the presence of the infectious diseases and also to assess the cell counts, viability and sterility. Several tests on the cord blood are performed. The processing in the laboratory of the opposite party involves separating the stem cells form the cord blood and cord tissue samples. The tissue is minced into small pieces and is incubated. After 28 days, the sample is spun to separate the umbilical cord tissue stem cells. A portion of the native umbilical cord tissue is processed so that future techniques for isolation can be deployed. The harvested stem cells are mixed with cryo-preservation solution for retaining viability during storage and are then transferred to specially designed cryo-bags, in smaller segments, in the form of tubes. The smaller segments are meant for sampling, testing for quality control and future testing. A preservation certificate indicating the cell count and the viability of the stem cells at the time of preservation is sent to the parents for their record.