Tuesday, February 25, 2014

Heart grown in lab to beat in body

Pushpa Narayan  
CHENNAI: Watching tiny cells grow into ahuman organ in a lab is no longer in the realm of science fiction. Scientists across the globe have managed to grow tissues and organs, and regenerative medicine is now one of the most promising fields in medical science. India is catching up and closer home, researchers at Indian Institute of Technology, Madras (IIT-M) have announced that a group of rats will soon receive heart or liver cells grown in their labs.

Patches of these cells will be surgically placed in rats at the Central Drug Research Laboratory, Lucknow. "It will open new avenues of treatment for humans," said Rama S Verma, professor, department of biotechnology, IIT-M. "It may delay or replace organ transplant." IIT-M programmed stem cells derived from cord blood and bone marrow to grow into liver cells. Its scientists grew these cells in a special polymer gel. "They matched the qualities of liver cells. In theory, these cells can reverse or delay organ damage in people with early stages of liver failure. If animal trials succeed, we will start trial in humans," Verma said. Simultaneously,they would do animal research using heart cells.

Attempts to reverse organ failure with a patient's own cells are being made in many countries. Though it is too early to say if regenerative medicine will do away with organ transplant, doctors said some clinical trials had shown positive results. Sankara Nethralaya, Arvind Eye Hospital and LV Prasad Eye Institute have used stem cells to reverse blindness. Opthalmologists use limbus stem cells in patient's eyes to repair the epithelial layer of cornea. "We avoid corneal transplant in at least 50% of the cases," said Dr S Krishnakumar of Vision Research Institute at Sankara          Nethralaya.

Doctors abroad have grown urethras, bladders, ear and bones from stem cells. Scientists are working with doctors to expand their applications to overcome the two disadvantages in organ transplants — use of immunosuppressants and organ rejection. "To prevent patients' immune systems from fighting the donor organ, we put them on drugs that suppress the immune system. Sometimes, despite medicines organs get rejected. When we use the patient's own cells, chances of rejection are minimal. Immunosuppressant drugs can be avoided," said liver transplant surgeon Dr Mohamed Rela, who works with Global Hospitals. His hospital plans to set up an animal lab to start a series of experiments on regenerative medicine. "From experience we know that stem cells are more likely to work in patients with acute liver failure because there is no structural damage to the organ. There is no ongoing threat to new cells. But transplant might be the only option for patients with chronic liver failure caused by hepatitis or alcoholism," he said.

To train doctors, the state medical university has collaborated with Nichi-In Centre for Regenerative Medicine to offer courses in regenerative medicine.
Senior surgical gastroenterologist Dr R Surendran, who started a stem cell lab at the Government Stanley Medical College, said, "It's the future of medicine. If we don't update ourselves, we will be left

Monday, February 3, 2014

Video-recording of consent for clinical trials driving away subjects, SC told

Dhananjay Mahapatra,TNN | Jan 31, 2014, 03.27 AM IST

NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects           of the drug, which is under clinical trial. 

This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.
 The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. 

Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits. It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said. Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs     were    completed. 

From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.
 The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population.
Posted by:
Gauri Shah(Faculty)