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Stem cells from laboratories not legal

Docs want therapy data to be standardised

Hyderabad: Laboratory grown stem cells used for treatments are still not approved in India and hospitals that are carrying out these procedures are being pulled up by the Drug Controller General of India.

A hospital in Pune, which showcased its treatment on the Internet, has been taken to task, and as a result hospitals in the city have to become cautious.

With new stem cell companies coming in the Indian market, the competition, along with the patients’ needs, are driving this experimental treatment which is still at the clinical trial stage.

Stem cell therapies are of two types single stage cell treatment, in which case stem cells are taken from the patient and immediately inserted in the injured or diseased area; and double stage cell treatment where it is cultured in a laboratory for 15 to 21 days and then introduced in the body.

The second stage of treatment requires monitoring and also its effects on patients must be checked. Orthopaedic surgeon Dr K. Raghuveer Reddy, who has used the treatment for cartilage damage, said, “The single stage cell treatment does not require permissions, but it can be done only on younger patients below 40.

The single cell treatment is not very effective for those who suffer orthopaedic or cartilage damage after 40 years.”

For such patients, the stem cells require to be cultured in a laboratory and only then can they be inserted in the cartilage to heal the injury.

So far, 2,000 patients have been treated with approved permissions in Hyderabad but the results are yet to be scrutinised to make it a standardised treatment.

Association of Stem Cell Banks of India president, Mayur Abhaya, said, “There have been studies done for cartilage, gangrene, dental treatment, diabetes, hair extracts and umbilical cord and most of them require proper scrutiny and approvals from various committees.

The government, along with experts, have to scrutinise the data and then make these commercially viable for patients.”

“There are some patients who want some relief from pain and to live a normal life, hence they opt for these treatments.

Till the results are good no noise is made but if something goes wrong, a hue and cry is raised.

Despite that, it is important to not commercially exploit it till all results are clear and the ill effects, if any, properly studied. Worldwide, stem cells are in the clinical stage and we have to wait for results,” said Dr Laxmi Kanakabushanam of KIMS Foundation, adding, “The procedures right now are all in the trial stage and the government has to come up with assessed results to scrutinise and standardise the treatment which is the need of the hour.”

The most important feature that has come forward in embryonic cells is that once they are cultured, they grow limitlessly.

Another senior researcher said, “This is a rare case but in an experiment it has come to the fore that stem cells from embryonic cells can become cancerous and can get very dangerous.”

( Source : dc correspondent )
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