Cytotron, the latest non-invasive technology to treat patients
with osteoarthritis of joints and terminal cancer, has recently got a shot in
the arm by receiving EU certification, says Rita Dutta
a time, when IGRT, IMRT, RapidArc and Cyberknife are breaking new grounds in
treating cancer and knee replacement have become the commonest treatment, a
new technology provides patients with wider choice for treatment and promises
a better quality of life. Known as Cytotron, it is developed and patented by
Bangaluru-based Centre for Advanced Research and Development (CARD), the research
wing of Scalene Cybernetics Limited.
What makes this technology unique is that without killing diseased cells, Cytotron
alters or regulates the cellular pathways and their protein synthesis pattern
in achieving normal cellular function. Explains Dr Rajah Vijay Kumar, Chairman,
Scalene Cybernetics Limited, who is a medical engineering specialist and inventor
of Cytotron, "It is established that TMP is one of the known cellular signaling
pathways. TMP pathways also regulate synthesis of various proteins at the appropriate
time in the living cells. Many illnesseslike cancer, heart disease, degenerative
disorders like cartilage loss and different kinds of inflammation are
also linked to disturbances in the protein transcription process. It was postulated
in 1993, after assessing an earlier study in 1987-88, that if appropriate method
can be developed to alter the TMP (in a controlled manner), most of these disorders
that are protein-linked can be tackled."
The development of this technology started way back in 1987 with a dual gun
device with just two RF guns. The next step was to extend the device to a six-gun
device, for laboratory trials and then came a device for exposing the whole
body. The first physical prototype of 360 degree rotational field exposure narrow
focused 96 gun device and that was for the first time named Cytotron in 1998.
After undergoing various lab tests, the first clinical trial phase I concluded
at CARD with good results. The (phase II) was started in Bangaluru under an
agreement with the Institute of Aerospace Medicine (IAM), Indian Air Force.
However, due to internal reasons in that institution and the premature retirement
of the principle investigator appointed by IAM, the project was terminated with
no conclusion and hence the trials had to restart all over again at CARD.
After various lab tests, safety standard tests and 'in silico' study, the project
was re-started in 2004 after obtaining necessary approvals from the institutional
ethics committee. As phase I trail of osteoarthritis had already concluded,
it started with treating osteoarthritis of knee joints (phase II) with objective
assessment, using MRI of the joints to measure cartilage thickness before and
after treatment. In cancer treatment, the trial was done as a companionate trial
on terminally ill cancer patients (phase I). " Phase II trial will soon
be concluded. Preliminary reports indicate that freshly diagnosed tumors respond
better to Cytotron treatment with fewer or no cancer spread, and better response
to other treatments," says Dr Vijay.
Over the Years
we alter TMP pathways and cellular signaling in a controlled manner, most
of these disorders that are protein-linked can be tackled"
- Dr Rajah Vijay Kumar
Organisation De Scalene
have improved in pain score, total knee score, total functional score and
range of movement, immediately after Cytotron treatment"
- Dr Ranjit Kumar
Principle Scientific Officer
Besides CARD, many institutes are using Cytotron with success.
Some of the institutes are Care Plus, Bangaluru; Sibia Medical Centre, Ludhiana;
Safe Health, Hyderabad; Samarpan Hospital, Jam Nagar and Goutam Hospital, Kochi.
Outside India, there are two centres in Malaysia CareNexus and Gleneagles Istan
Medical Centre. There are two more Cytotron at Quress Liden in the Netherlands.
The technicians operating Cytotron at all these centres are trained by CARD.
CARD conducts certification programmes for technicians and medical professionals
in operations and dosimetry.
Various centres prefer Cytotron as it requires no surgery- causes no skin scars,
is painless, comfortable and safe, without any known side effects or complications.
Cytotron requires no anaesthesia or blood transfusion. As it requires no hospital
stay, patients can return to work daily after the treatment without having to
take leave from work.
Besides Indians, patients are trooping in from countries
like Malaysia, Singapore, Netherland, Indonesia and the Middle East. The charges
for treating arthritis patients ranges from Rs 90,000 to Rs 1,20,000. There
are no charges for treating cancer patients at CARD, as trials are still on.
Cytotron recently received a big boost when it obtained the
European Union (EU) Certification under Annex II, Section 3, of the Medical
Devices Directive (MDD), 93/42/EEC as class IIA Medical Device. The CE certification,
which is one of the most respected marks in the world, ensures adherence to
the various consumer safety, health and environmental benchmarks of the EEA
countries. "We have received requisitions to install Cytotron from Europe,
Middle-East, Australia, Malaysia, Canada, New Zealand, South Africa and Mexico.
We are expecting over 1,000 Cytotron machines to be installed around the globe
by 2015, providing relief and better quality of life to patients," says
an elated Dr Vijay.
How Cytotron Works?
It uses Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) technology
to deliver complex time, amplitude and frequency modulated rotating quantum
nuclear magnetic resonance beams to diseased tissue, using packet switching
techniques. Cytotron produces poly-dimensional 'Rotating Target-Specific Modulated
Radio Frequency Radiation' in the presence of high instantaneous magnetic field.
Cytotron looks like a modern whole-body MRI scanne, but has a bigger bore. The
bore has a gantry that carries about 864 guns (older versions have 288 guns).
Each of the guns produce high instantaneous magnetic field and radio frequency.
It also consists of a special near field antenna and parabolic reflectors to
deliver these signals. These guns emit packets or quantum of programmed signals
in time and space that are focused to the target, using laser guides. These
emitted string of packets, which contain the dosimetry required for a specific
medical condition is delivered by the antenna. The beams are then rotated in
360 degrees around the target. The patient is made to lie down on a traveling
bed. When the bed travels into the bore of the Cytotron, the laser guides come
on and the technician focuses the guns as per a pre-prepared template. The secondary
dosimetry that is prepared by a trained doctor is initiated from the control
room, and the Cytotron starts its job. After completing the assigned dose of
radiation, the device automatically stops. The patient is then removed out of
Osteoarthritis of Knee
In a study to establish tissue regeneration, CARD used Cytotron on 380 knee
joints with confirmed diagnosis of osteoarthritis, who were advised total knee
replacement. The male to female ratio undergoing the treatment was 262:118 and
their mean age was between 28 to 57. These patients were treated with Cytotron
focused on both knees for 30 minutes every day for 21 consecutive days. They
were evaluated before, and three month post treatment with the Knee Society
Scoring System (KSSS), dynamometry and MRI evaluation of the knee joint using
3D FLASH sequence with water excitation. Says Dr Ranjit Kumar, Principle Scientific
Officer, CARD, "There was highly significant improvement in pain score,
total knee score, total functional score, range of movement and force of extension,
immediately after the treatment. This improvement persisted when evaluation
was repeated after three months."
Three-month post-treatment showed that there was a significant increase in Cartilage
Thickness (CT) as established by MRI. In the studies done on osteoarthritis,
85 per cent of the patients treated during the phase II clinical trials were
almost pain free with increased movement of their treated joints and could walk
longer distance than what they could before the treatment, climb stairs and
drive. Also, almost all the patients treated had statistically significant increase
in cartilage thickness as indicated by MRI scans. It was also observed that
a significant effect, that is the increase in cartilage thickness, is due to
Cytotron exposure only. There were no gender difference or laterality effect
observed in response to Cytotron treatment. More than 2,500 joints have been
treated for osteoarthritis at various centres in India and abroad.
Cytotron for Cancer Patients
In a multi-centric trial, CARD is using Cytotron to treat patients with terminally
ill cancer patients during the last four years. The purpose of the study is
to arrest the growth of cancer cells, prevent further spread of the tumor and
to provide the patients with better quality life. In case of terminal cancer
patients, the success rate means a little different from that of osteoarthritis.
"Terminal cancer patients have a few weeks or months to live. So, in research
involving terminal cancer patients, a one-year survival rate is taken. Out of
the treated terminal cancer patients, the one-year survival rate was 52 per
cent (including patients who died of heart attacks, infections kidney failure
etc) while 92 per cent of the patients had improved quality of life, for whatever
period they lived. All our research outcomes are audited by international third
party audit and not the mere analysis of the project investigators," says
Dr Vijay. The youngest patient treated on Cytotron so far, is two-and-half-year-old
and the oldest is 92-year-old. At CARD, 140 terminal cancer patients have undergone
treatment so far, through the Cytotron during clinical trials.
|Ludhiana-based Sibia Medical Centre is using Cytotron
since March 2006. "Ours is the first commercial centre providing Cytotron
therapy after the invention of the equipment," says Dr SS Sibia, Head,
Sibia Medical Centre.
So far, the centre has treated about 500 joints for osteoarthritis
and about 30 cancer patients. "We have taken up patients for treating
osteoarthritis of the knee, hip, ankle, shoulder and spine. We have also
taken up patients for treatment cancer tumors including metastasis of
brain, lung, heart, pancreas, liver, ovary, colon-rectal, lymph nodes,
prostate, melanoma, bone, etc," says Dr Sibia.
Symptomatically, in arthritis over 90 per cent patients
improve, 70 per show good improvement and 20 per cent fair improvement.
Cartilage growth has been reported in almost all patients. "Most
cancer patients have shown initial improvement, but as we have started
recently, it is too early to say about the long term result," he
Why did he go for Cytotron when there are other treatment
methods available? "We believe that non-surgical, non-invasive treatments
should be tried before going for lesser safe and traumatic treatments,"
Do all patients qualify for Cytotron treatment? "Other than some contraindications,
there are absolutely no restrictions. The contraindications are to stop certain
group of drugs, that use the same or similar cellular pathways as Cytotron,
like calcium channel blockers, proton pump inhibiters, NSAIDs and alkaloids
(also food containing alkaloids) for all regenerative treatments, but for treatment
of degenerative treatment like cancer, they are to
stop drugs that act as calcium channel blockers and proton pump inhibitors,"
says Dr Vijay. Cytotron treatment is known to deplete all B-vitamins, and so,
this is supplemented for all patients during the course of treatment.
Can a patient with cardiac stents, orthopaedic implants or pacemakers be treated
with Cytotron? "None of the implants are a contraindication as long as
they are MR compatible. Pacemakers are absolutely contraindicated, even if it
is MR compatible. Pacemakers or any other radiosensitive implanted devices should
not be allowed within 15 metres of the Cytotron," he says.
Is RFQMR harmful? "Radiations in the lower end of the spectrum are not
harmful like the higher-end of the spectrum, where the ionising radiations can
kill biological tissues. Low-end spectrum frequencies can cause minor physiological
effects like depression or pain or some metabolic abnormalities, if uncontrolled,"
adds Dr Vijay.
With more centres evincing interest in using Cytotron and more patients benefitting
from it, CARD is not only manufacturing more Cytotron equipment at its Bangalore
campus, but is also promoting further research on using it for treating other