The US regulators have given the go ahead for a biotech company to carry out the world's first trial of a treatment using embryonic stem cells, in this case to treat victims of spinal cord injury that leaves them unable to walk.

Although heralded as an early sign of new US president Obama's support for embryonic stem cell research, Dr Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, California, the company that will be carrying out the trial, told Associated Press that strictly speaking it was not so in this case, since the next phase of the project would have been eligible for federal funds under Bush. It was the earlier development phases that had to be done with private funds because of funding restrictions on embryonic stem cell research brought in by Bush in 2001, said a report in Times Online.

Today's ruling by the US Food and Drug Administration (FDA) allows Geron to give 8 to 10 patients with spinal cord injury a single injection of cells made from embryonic stem cells. The testing will be done at several medical centres throughout the US and the patients will receive their injections within 2 weeks of their injury; unfortunately patients whose injuries are older than this are unlikely to benefit from such therapy.

According to a Geron statement, the Phase I trial is designed to establish the safety of the treatment, called GRNOPC1, in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

Okarma told AP that they will also be looking for the possible return of feeling or movement in the legs. Animal studies have shown that injected embryonic stem cells can turn into specialist cells that replace damaged sheaths around nerves that have suffered "demyelination" and thereby restore their ability to send signals that control muscle and sense feelings.

Embryonic stem cells are like master cells, they can become virtually any cell of the body, which comprises about 200 types of tissue. There are other kinds of stem cells too, like adult stem cells, but they are more limited in what types of cell they can become and harder to "coax", so embryonic stem cells are considered the "gold standard" in stem cell research. They are however more controversial because harvesting them involves destroying embryos, whereas adult stem cells can be recovered without harming the donor.

If successful, the trial will lead to therapies with the potential to transform the lives of thousands of people who every year become paralysed from the chest down, and for whom few treatments exist. Experts predict that if successful, the therapy could be in general use within three to five years.

Okarma said in a press statement that:

"This marks the beginning of what is potentially a new chapter in medical therapeutics -- one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function by the injection of healthy replacement cells."

He said that: "the ultimate goal is to achieve restoration of spinal cord function".

Although the FDA decision is independent of the White House, it is being received as a symbol of a new attitude to embryonic stem cell research and Obama is expected to start lifting funding restrictions next week, said a Times Online report.

Dr Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University, said that:

"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury."

"Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year," he added.

Polling figures suggest most Americans are in favour of stem cell research, but it was strong opposition lobbying that persuaded Bush to impose restrictions on federal funding.

Okarma said that the delay caused by the funding restriction meant there "are people out there who might have benefited, but who now cannot," he told the press.

The Delhi High Court Friday agreed to hear the plea of industrialist Anil Nanda against turning the Delhi-based Escorts Heart Institute and amp; Research Centre Limited (EHIRCL) into a limited company from a charitable institution.

A single bench of the court had in July last year allowed the plea of Rajan Nanda, Anil's elder brother and the former chairman of Escorts Hospital, to convert the hospital into a company, which was challenged by his brother.

Anil Nanda has sought restoration of the institute to its original status of a charitable trust, but his plea could not be entertained as he had not sought permission of the court before filing the suit as provided in the Civil Procedure Code.

A division bench comprising Justice Mukul Mudgal and Manmohan allowed the plea of Anil Nanda and asked the single bench to hear the matter.

Anil Nanda in his petition had submitted that EHIRCL was a charitable trust established by his father H.P. Nanda in 1981 and the DDA had provided it two acres of land at Rs.10,000 per acre.

He alleged that after the death of his father in 1999, Rajan Nanda and others of the institute hatched a conspiracy to grab its huge reserves and substantial assets by setting up another society with an identical name in Chandigarh.

In a major breakthrough of medical science, a team of scientists led by Indians has identified a defective gene responsible for the sudden cardiac arrest and deaths among the population in the Indian sub-continent.

The study piloted by the Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) and involving scientists from India, Pakistan, the US and Britain has given hope to 60 million people carrying the defective gene by way of stem cell therapy or a possible drug.

Announcing the results of the five-year long study, CCMB director Lalji Singh told reporters here Monday that it was the defect in one gene Myosin binding protein-C (MYBPC3), which regulates pumping of blood, accounting for 45 percent sudden cardiac arrests or sudden death due to heart problems.

'We found this particular gene in certain individuals with 25 base pairs missing and it makes defective protein,' he said.

'This, however, does not represent all the problems of heart. Two to five percent of heart problems are due to sudden heart attack and this represents 45 percent of that two to five percent,' said Singh, who was one of the eminent scientists who participated in the study.

The study was conducted by an international team of 25 researchers led by the CCMB scientists. The results of the research were published in the prestigious scientific journal 'Nature Genetics' in the US.

Significantly the researchers found that general defect was found only in the people of Indian sub-continent, including countries like India, Pakistan, Sri Lanka, Indonesia and Malaysia but not in other countries.

'Bangladesh was not covered by the study but since it has the same origin, we believe that the defective gene is also found in that country,' said the CCMB director.

The scientists analysed the DNA of 800 cardiac patients from Hyderabad, Madurai, Thirunalveli, Thiruvananthapuram, Kozhikode, Mumbai, and Bhubaneswar, Delhi and Chandigarh and 699 normal individuals from the ethnically matching groups.

The scientists also screened 6,273 randomly selected individuals to find out how widespread the mutation was in the Indian population. These cases were from 107 ethnic populations including primitive tribes, tribes, castes, subcastes and people belonging to all the religious groups including Hindus, Sikhs, Muslims and Christians from across the country.

'If there is only one defective gene in an individual, he may live up to the age of 40 to 45 and then suddenly die because of heart attack without showing any symptoms before. We can identify such individuals in familiar cases (where there are families where people die because of sudden heart attacks).'

'Any gene occurs in pairs, one coming from father and one coming from mother. If both genes are defective, you call it homozygous.'

He said such people could be identified much before they are born through pre-natal diagnosis.

'Taking the sample of mother's blood, we can tell if the one gene of the baby is defective or both. If both genes are defective we can advise parents to have abortion. If one gene is defective, the doctors can advise the patient to live stress-free life to live longer.'

He said the study had thrown an opportunity for pharmacological companies to develop a drug which can degrade one of the defective proteins.

'There is a machinery in the cell which degrades abnormal protein. As you become older beyond the age of 40, the machinery becomes weaker and the cell starts accumulating both defective protein as well as normal protein.'

Lalji Singh said such individuals might get some treatment through stem cell therapy in future.

K. Thangaraj, a CCMB scientist, said it was estimated that about 60 million people in the region were carrying this mutant gene. About 30 million people in India suffer from heart disease, and by 2010 India will carry 60 percent of the burden of world's heart diseases.

Bollywood superstar Shah Rukh Khan has committed to bear all the expenses for the treatment of two Kashmiri orphan children who suffered severe burns during a terrorist grenade attack in Srinagar, doctors said Tuesday.

'He has made it clear - 'no limits' - to the expenses for treating Mudassar and Amina,' Ali Irani, the head of department, physiotheraphy and amp; sports medicine at Nanavati Hospital, Vile Parle, told IANS.

A little over two months ago, the home of the two kids in Jammu and Kashmir's summer capital Srinagar was attacked by terrorists. Mudassar and Amina's parents were killed in the grenade attack, while the children suffered burn injuries.

The children suffered some grenade shrapnel injuries and severe - more than 30 percent - burn injuries and they were shifted to a local hospital in Srinagar, Irani, a physiotherapist, said.

When Irani visited the hospital under the auspices of the Indian Association of Physiotherapists, his attention was drawn to their plight.

In turn, Irani suggested that they could be shifted to Mumbai for getting the best treatment, at the Nanavati Hospital - where the children were brought to in December.

Although it would have been easy to get completely free treatment from any doctors, there would be many other expenses of the children to be handled, and Irani requested Shah Rukh Khan for help.

Not only did Shah Rukh readily agree to the suggestion but he also visited the two orphans at the hospital and has promised to take them to his home in Bandra to play with his children, Aryan and Suhana.

'Mudassar suffered severe burns on his face, while Amina's arms and hand have been burnt - but there will not be permanent damage,' Irani said.

The two children have already undergone four surgeries which were performed by Atul Shah and L. Dhami - 'We don't know how many more surgeries they will required or when they can be discharged,' Irani said.

This is not the first time that 44-year-old actor has contributed to a noble cause - according to Irani, he has been doing it for nearly the past nine years.

'He has requested that this must be kept completely confidential, but the information somehow leaked out. There is no count of the number of children that he has helped so far,' Irani said.

A few years ago, Shah Rukh had donated Rs.5 million (Rs.50 lakhs) to the children's ward of the hospital in memory of his mother, Lateef Fatima Khan, who died 18 years ago.

NEW DELHI: Every 25th Indian carries a mutant gene which makes the person vulnerable to an "almost guaranteed" risk of sudden cardiac arrest,
results of a study published today suggest.

The mutated gene is carried by six crore people around the globe of which more than four crore are Indians, researchers said. 'Every 25 th Indian carries a mutation almost guaranteed to lead to heart problems,' the study said, the findings of which were published in latest edition of the journal 'Nature Genetics'.

'We can confidently say that four per cent of the Indian population is at risk of a sudden cardiac arrest as they carry this mutant gene,' Kumarasamy Thangaraj of Centre for Cellular and Molecular Biology (CCMB), Hyderabad, who led the study, said.

The CCMB is a government lab functioning under the Council of Scientific and Industrial Research (CSIR). India has a burgeoning population of heart patients and according to a previous study the country will constitute 60 per cent of global heart patient by 2010. The new findings shed light on the genetic pre-disposition that increases risk of heart disease in Indians.

People having this mutation have 25 letters of genetic code deleted from a gene MYBPC3 – responsible for production of heart muscle protein. The altered form produces an abnormal protein which disturbs the structure of heart muscle fibre.

'Those having the altered form of gene have seven folds higher chances of getting a cardiac arrest than normal people. Besides, these people have no warning about the danger which makes it worse,' Thangaraj said.

'Young people degrade the altered protein, hence they don't generally show symptoms. But with age, the degradation becomes less effective, making a mutant protein build up and symptoms develop,' said Chris Tyler-Smith, a researcher from Wellcome Trust Sanger Institute, UK, in an e-mail interview.

'From our data, around 90 per cent of people carrying this form of gene, who live to old age will develop symptoms of heart disease,' Chris said.
The mutation was discovered five years ago in two Indian families but its significance became apparent only after the study of about 1,500 people from different parts of country.

The study involving 25 scientists from four countries shows that gene has slightly higher prevalence in south Indian than in the north but affects all groups and religions, he added.

'We think that the mutation arose around 30,000 years ago in India, and has been able to spread because its effects usually develop only after people have had their children. A case of chance genetic drift: simply terribly bad luck for the carriers,' said Perundurai S Dhandapany from Madurai Kamraj University, one of the researchers.

'If this mutation is present in both copies of chromosomes (one from father and another from mother), chances of getting a heart attack are even higher than the person who has got the mutant gene from only one of the parents,' Thangaraj said. Researchers are of the view that this finding will help in identifying potential heart.