Ahead of a planned five-centre nationwide trial, the Indian Council of Medical Research (ICMR) has approved a special project at the AIIMS Trauma Centre in New Delhi where stem cell therapy will be conducted on complete paraplegics and quadriplegics to try and revive limb function.
A similar trial will be conducted at the Indian Spinal Injuries Centre (ISIC) in Vasant Kunj, south-west Delhi where 21 patients have already been registered. This project too has been approved by the ICMR. Senior ICMR scientists from the apex committee to monitor stem cell research said the five-centre trial will be coordinated from ISIC and is in the final stages of approval. “This will be the first national ICMR trial of autologous bone marrow stem cell transplant on complete quadriplegics and paraplegics. We are finalizing the number of patients. The ISIC will be the coordinating centre. The next meeting has been scheduled for December 4,” a senior scientist said.
An autologous stem cell transplantation is a procedure in which stem cells are removed, stored and returned to the same person. For its project, the AIIMS Trauma Centre has registered eight patients. They will be injected with stem cells from their own bone marrow to see if the damaged neurological function can be regenerated. Doctors have cautioned that earlier trials on incomplete quadriplegics and paraplegics have not suggested significant clinical improvement.
Dr. Deepak Aggarwal, associate professor of neurosurgery at the AIIMS Trauma Centre who is coordinating the study, said: “We have necessary clearances from our internal ethics committee and the national apex committee for stem cell research and therapy which has members from the ICMR and Department of Biotechnology.”
“We are trying to see if injecting patients of irreversible spinal cord injuries with stem cells from their own bone marrow, under autologous stem cell transplantation, can help regenerate neurological function,” he said. According to Dr. Aggarwal, clinical evidence in previous international trials have not given “satisfactory results”. This is the first time that AIIMS is undertaking such a project.
At the ISIC, doctors have selected 21 complete paraplegics who are being injected with stem cells retrieved from their own bone marrow within 10-14 days of injury. “We had done one project in 2009 to see the use of stem cell transplant in restoring limb function on spinal cord injuries, but we had only selected chronic patients where the time lapse after the injury was far more. We could not demonstrate any clinical improvement. One criticism was that the spinal cord loses its plasticity and ability to regenerate after such a long time,” Dr. H S Chhabra, medical director at ISIC, said.
In the 2009 study, where five patients were selected, the site of stem cells was the olfactory mucosa or the upper region of the nasal cavity. For the new trial at ISIC, stem cells are being retrieved from the bone marrow of patients. At AIIMS, patients will be monitored for six months after one procedure. If there is no significant change, another procedure of extraction of stem cells and autologous transplantation will be repeated. There will be follow-ups for two years.
Of the eight patients shortlisted for the project at AIIMS, three are quadriplegics and have lost function in all four limbs. Patients were evaluated to ensure only those with “complete” loss of limb function were included, and all within six months of injury.
At ISIC, the 21 patients have been divided into three arms. The first group will be injected stem cells directly into the spinal cord, at the site of injury. For the second group, stem cells will be injected into the cerebrospinal fluid that surrounds the spinal cord.
The third arm, which will be the control arm, will not be injected with stem cells, but given other rehabilitative therapies. The functional outcome of all three groups will be compared at the end of two years.