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Scalene to recruit 300 MS patients for trials to assess Cytotron performance
Nandita Vijay, Bangalore | Monday, August 9, 2010, 08:00 Hrs  [IST]

Scalene Cybernetics, an indigenous medical technology major is gearing up to conduct clinical trials of patients suffering from multiple sclerosis (MS) using the Cytotron, which is based on Rotational Field Quantum Magnetic Resonance (RFQMR) technology.

The company has initiated a large population study and will recruit around 300 patients. However, a pilot study was undertaken last year after obtaining clearance from the Institutional Ethical Committee on a small number of MS patients and the response was encouraging. This has prompted for this large scale study, Dr Rajah Vijay Kumar, chief scientific officer and chairman, Scalene Cybernetics told Pharmabiz.

Cytotron is based on the concept of “tissue engineering” where appropriately modulated RF beams cause tissue regeneration. The technology has been proved to be beneficial in the treatment of osteoarthritis or tissue degeneration as in Cancer.

“In MS we will be using the technology of tissue regeneration for repair and regeneration of myelin sheath covering the nerve fibres. The pilot trial indicated marked improvements of symptoms like visual disturbances, muscular spasticity, urinary incontinence, inability to walk, lack of coordination for patients,” he added.

The research team comprises Dr Varadarajulu, neurologist and currently medical advisor for Centre for Advanced Research and Development (CARD) and principal investigator of this project, Dr Ranjit Kumar, Principal Medical Officer and Dr Anjana Rani, Scientific Officer, Scalene are the co-investigators of the project. The investigators have obtained the necessary permission from the Institutional Ethical Committee for conducting this study to further verify the effectiveness of this therapy in MS population.

After the completion of the large population trial, the technology will be made available to the existing centres and offered to new neurological centres . The company has a presence in Europe, North America, Middle East, Singapore, Malaysia. It will extend the treatment technology once established clinical trial data on its efficacy is made available.

Since Scalene is the research and technology provider it will not treat but volunteer patients with confirmed case of MS and they could take the advantage of this clinical trial by enrolling themselves with the registrar at CARD, he said.

MS is a chronic neurological disorder affecting the central nervous system. Currently there is no cure. Globally medical experts are conducting trials using drugs and technologies. But RFQMR is being used for the first time to treat MS through Scalene’s indigenously built Cytotron, stated Dr Varadarajulu.

In America alone there are more than 5 million MS patients. According to Dr Ranjit Kumar, MS is caused by non production of a specific protein by the oligdendriocytes which is responsible for the synthesis of myelin. Cytotron is a non traumatic and non invasive procedure with no adverse side effects.

A few weeks ago Scalene has introduced Haemoseis 3D Vasculography for detection of cardiac disorders for which it has received favourable response from major hospitals. In order to develop more medical technologies, the company allocates 40 per cent of its annual revenue towards research.

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