ASSI issues
a position statement to caution public on the unauthorised use of unproven
treatments
New Delhi,The Association of Spine Surgeons of India
(ASSI) has recently come up with a position statement to caution people about
the rampant & unauthorised use of unproven
treatments especially stem cell treatment for the spinal cord injured. 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. The position statement is available on
ASSI’s website www.assi.in
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.
“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 - ASSI and Prof
& Head, Department of Orthopaedics - 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”.
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.
Cautioning
patients on the issue, Dr.
Sajan Hegde, President-ASSI, Consultant Spine Surgeon & Head of Department
of Orthopaedics, Apollo Hospitals, Chennai
says that, “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.
About Association of Spine Surgeons India-
Formed
in 1985, the Association of Spine Surgeons of India (ASSI) has been promoting
scientific spine care, both surgical and non-surgical, in
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