The Association of Spine Surgeons of India (ASSI) has recently come up with a position statement to caution people about the rampant and unauthorised use of unproven treatments especially stem cell treatment for the spinal cord injuries.

ASSI feels there is an urgent need to create awareness on the issue, and advise the spinal cord injured and their families to make informed decisions regarding the plethora of so called “effective” stem cell and cellular transplants being offered across the world, typically for large sums of money.

Spinal cord injury is one of the most devastating ailments which can afflict mankind and complete injuries leave the person paralyzed below the level of injury. Such injuries have serious medical, psychosocial and economic consequences on not only the individual but also the whole family. Since the prognosis for neurological recovery in complete spinal cord injuries is poor, the spinal cord injured and their families look forward to any treatment which could help them to recover and they are often desperate in this regard, according to a release here.

 “Over the past decade various clinics in India and abroad have started offering experimental treatments, often involving transplantation of ‘stem cells’ or other cells” says Dr. Ram Chaddha, president-elect of  ASSI and Prof & Head, Department of Orthopaedics at K.J. Somaiya Medical College, Sion, Mumbai. “These cell-based therapies are advertised as having beneficial effects, leading to some recovery of function, even though there is little or no evidence supporting such claims”, he added.

Providers of these cell transplant procedures attempt to establish credibility by citing experimental studies that have no direct relation to SCI. They also rely on reports from patients or family members. Patient-reports are tainted by what is known as the placebo effect where the patient’s belief in a treatment results in their description of an improvement when nothing has actually changed. This is especially true after SCI where sensation, muscle spasms or residual reflexive movements can vary daily. The only accurate way to determine that a treatment is beneficial is to carry out a properly designed study with an appropriate control group, the release said.

Cautioning patients on the issue, Dr. Sajan Hegde, president of ASSI and Head of Department of Orthopaedics at Apollo Hospitals, Chennai said, “Although some forms of stem cell transplantations have been successfully used to treat some blood and immunological disorders, there has been no established evidence to-date that stem cell and cellular transplants are successful for management of human spinal cord injuries. Instead people with spinal cord injury can get back to a meaningful lifestyle with proper conventional medical care and rehabilitation training.”

 “It is true that stem cell and cellular transplantation hold a great promise and potential. As of now, most cell-based transplantations carry significant safety risks. Such transplants with proven risks may be justified only if expected benefits outweigh the risks. However proof of benefit of such transplants come only from preclinical (animal) studies. Such studies have a lot of limitations since they do not mirror SCI in humans. It is important to conduct valid clinical trials to evaluate whether stem cell and cellular transplants can be offered as a valid option after SCI. Some properly conducted trials are now being undertaken, but it is advisable to wait for the results from these objective studies” says Dr. H.S. Chhabra, Secretary, ASSI and Medical Director, Indian Spinal Injuries Centre.

Citing the National guidelines on stem cell research published by Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT), Govt. of India, Dr. Saumyajit Basu, Jt Secretary-ASSI, Consultant Spine Surgeon, Park Clinic and Kothari Medical Center, Kolkata says that “Any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial shall be considered as malpractice.”

 While ASSI acknowledges the possibility that in future stem cell and other cellular based interventions may be accepted as a valid choice of therapy after SCI, the evidence base for the same must come from a valid clinical-trial program. Currently, it is unethical to offer experimental interventions that are not yet proven to be safe or effective and more so to charge patients for this.