On Monday, the Amloh court in Fatehgarh Sahib will begin hearing a case that experts say could raise questions over existing laws regarding voluntary donation of stem cells or bone marrow for transplantation in patients with thalassaemia.
A month after she turned seven, Harleen Kaur died at the Christian Medical College and Hospital (CMCH), Ludhiana, on November 4, 2014 after her stem cell donor backed out from the procedure at the last minute.
Her father Inderpreet Singh has now taken the CMCH and Chennai-based DATRI Blood Stem Cell Donors Registry to court.
Harleen was suffering from thalassaemia major, a congenital disorder which required monthly blood transfusion. Her parents opted for a procedure in which her stem cells would be replaced with healthy ones from a donor. It would save her from monthly hospital visits and, her parents hoped, a better life.
“But this procedure first needed her existing stem cells to be destroyed with chemotherapy,” Inderpreet told The Sunday Express. “Only then could the new cells be added. A matching stem cell type could be found only in Chennai through Datri.”
As per the father’s petition, two sessions of chemotherapy were administered on Harleen October 10. On October 11, just five days before the transplant was scheduled, the donor backed out due to “personal reason”. From then on Harleen’s condition worsened and she never recovered.
In his petition, Inderpreet questioned why CMCH doctors, despite having a bone marrow stem cell preservation unit, failed to preserve Harleen’s cells (to be used in case the transplanted cells were rejected by her body), and why the chemotherapy was started even when the donors’ cells had not arrived at the hospital.
The post mortem report submitted by a panel of doctors (a copy of which is with The Sunday Express) on November 5 says that Harleen died due ‘septicaemia as result of fulminant infection due to hypocellularity of bone marrow which is sufficient to cause of death’ (abnormal decrease in number of cells).
In the petition that will come up for hearing on February 8, the court has summoned Dr Joseph John, professor, department of Department of Clinical Haematology, Haemato-Oncology & Bone Marrow (Stem Cell) Transplantation, CMCH Ludhiana and Raghu Rajagopal, CEO, Datri.
Dr John was issued an anticipatory bail from Additional session judge Fatehgarh Sahib Manjot Kaur on January 25.
Dr John has submitted to the court that ‘after refusal from Datri, chemotherapy was stopped immediately and antibiotics were given and efforts were made to find another donor through DKMS (Germany) but patient succumbed on November 4 due to overwhelming fungal infection.’ He was granted anticipatory bail by a court in Fatehgarh Sahib on January 25.
In his defence, Dr John has said that “after refusal from Datri, chemotherapy was stopped immediately and antibiotics were given and efforts were made to find another donor through DKMS (Germany) but patient succumbed on November 4 due to overwhelming fungal infection”.
In a written reply to queries from The Indian Express, Dr John said: “Transplant is the only curative form of therapy which can be done by matched related donor within family or voluntary donors. In case of voluntary donor transplant, it is a standard practice that the stem cell donor does not come to the transplant centre at the time of transplant. The identity of the donor is not known to us and is only available with the registry and the stem cell collection centre where the donor is from.”
“The usual procedure is that the stem cells are collected at the collection centre and the stem cells are carried by the courier to the transplant centre. It is also not a standard practice to cryopreserve (freeze) the donor stem cells prior to conditioning and always fresh stem cells are preferred. It is also not a standard practice to freeze the patient’s own stem cells before starting the conditioning as this has been proven ineffective in many studies,” he wrote.
“As per the current practice, in case of an unexpected event by which the stem cells does not arrive, it is the discretion of the transplant physician to choose the most appropriate intervention in the best interest of the patient. In this situation, an alternative donor (10/10) from DKMS was arranged and recovery of counts was anticipated. It is unfortunate that the patient succumbed to fungal infection despite supportive measures before the stem cells could arrive. Fungal or bacterial infections are potential complications seen in transplant procedures which could happen even if the stem cells were infused. The estimated transplant-related deaths occur in 10-30% of the patients,” Dr John wrote.
Dr Subhash Batta, former Ludhiana civil surgeon, who investigated the case, said, “It is a rare case. Currently, we have no law which deals with cases with donors’ unethical behaviour. What can doctors do if donor backs out at the last moment? We had studied the case from all aspects but ultimately, we found that the doctor was not at fault. It was the donor who backed out.”
DATRI CEO Rajagopal, speaking over phone from Chennai, said, “We tried our best to counsel the donor after he backed out but as per existing laws in India, stem cell donation is voluntary. It was completely unexpected that the donor would back out. It had never happened until now. And this is the only case where the patient died after the donor backed out. We still cannot reveal the identity of that donor as per agreement. We reimbursed the entire amount to the family. There is nothing more we could do. The donor, in any case, cannot be booked as per existing laws.”
“My daughter died after a month of severe pain. She lost her hair and there were many black marks all over her body. She would have lived had her own cells been preserved. If CMCH is not guilty and so is Datri, then who is? Was it our fault that the donor backed out? Who was responsible for it? We need an answer to this,” said Inderpreet.