In a first in India, doctors used stem cells to treat a premature newborn for a severe broncho-pulmonary disorder, after four months on a ventilator did not improve his condition. Rudransh Dubey, now 10 months old, weighs over 5 kg in contrast to the 600 gm recorded at his birth.
The use of stem cells remains a contentious topic, with the Ministry of Health and Family Welfare's new notification - New Drugs and Clinical Trial Rules, 2019 - for the first time including "stem cell-derived products" as "new drugs" which require a licence from the central drug licensing authority for use. Experts have warned that its use in the absence of scientific evidence poses a risk of causing tumours.
Rudransh was born in June 2018 at Cloudnine hospital, Malad, after 26 weeks of pregnancy. The premature baby had underdeveloped lungs. At least 50 per cent of babies weighing less than 1 kg suffer a risk of pulmonary dysplasia, affecting their breathing and lung function. In September, he was shifted to Surya Mother and Child Care Hospital, to which at least 150 to 200 pre-term babies are admitted in a year.
Rudransh, who suffered from a severe form of this condition, would "turn blue every week due to hypoxia. Normal medication or ventilator was not working to improve his health. We were pushed to a wall with no option left, that is when we thought of stem cell", said neonatologist Dr Nandkishor Kabra. The baby's father, Pramod Dubey (44), a chartered accountant, said the family agreed to the stem cell treatment as no alternative was left.
In October 2018, doctors pumped 8 ml of diluted umbilical cord stem cells into the baby's lungs, through a pipe inserted in his mouth. The stem cells regenerated the underdeveloped lung muscles, vessels and alveolar lining in the lungs, said Kabra.
The baby's mother, Meenakshi (42), said his health improved gradually and he was slowly weaned off ventilator support. The stem cells, hospital director Dr Bhupendra Avasthi claimed, also removed fibrosis that had developed as a result of artificial air being pumped into Rudransh's lungs for months. "We don't want to remember the last eight months. Every day, my wife used to leave home by 9 am, staying by his side the entire day," said Dubey. The baby is still hospitalised and his weight has started increasing.
Doctors treating him claimed his condition was a severe and rare case in which no medicine worked. But they cautioned against generalised use of stem cells for newborns. Neonatologist Kabra said, "We would not advise this for every newborn. It must be taken up on a case-by-case basis with parent's approval and permissions from ethics committee."
According to the Indian Council of Medical Research (ICMR), stem cells are in the process of regulation.