By Andy Coghlan

A CLINIC claims it has used stem cells to treat Down’s syndrome in up to 14 people. “As far as we know, it’s the first time that stem cells have been used to treat Down’s syndrome,” says Jyoti Titus, manager at Nutech Mediworld clinic in New Delhi, India.

The announcement has set alarm bells ringing. It’s not clear to independent stem cell or Down’s experts how stem cells – which can form many types of tissue – might treat Down’s, a genetic disorder caused by having an extra chromosome.

Down'sDown’s: an extra chromosome 21 – Department of Clinical Cytogenetics, Addenbrookes Hospital/Science Photo Library

“The use of these cells does not make biological sense and may place the babies at considerable risk of side effects,”says John Rasko of the International Society for Cellular Therapy.

Clinically proven stem cell therapies are only just starting to become available. The first off-the-shelf stem cell treatment to gain regulatory approval was launched in Japan last year, and prevents transplanted organs from attacking their recipients. A number of research teams are putting other experimental stem cell therapies through stringent clinical trials.

But hundreds of clinics worldwide already offer stem cell treatments unvetted by regulatory authorities. A patent held by the clinic’s medical director, Geeta Shroff, from 2007 suggests that the cells offered by Nutech Mediworld could be helpful for over 70 types of conditions, from Down’s syndrome to Alzheimer’s disease, and even vegetative states.

“The use of stem cells doesn’t make sense and may place the babies at considerable risk”

Most treatments for children with Down’s syndrome centre on support – including speech and behavioural therapies. But in a study published last year Shroff, reported that a baby with Down’s syndrome developed better understanding, improved limb muscle tone, and the ability to recognise his relatives after receiving stem cells (Journal of Medical Cases, doi.org/bx3v).

No controls

“There’s no comparison to similar individuals with Down’s syndrome, and no indication this therapy had any effect whatsoever, so the author has no basis at all for saying the injections were beneficial,” says Elizabeth Fisher at University College London.

But since no other treatment was given, it is evident that the child’s improvements were due to stem cell treatment, says Titus. “He started babbling and crawling, and his facial features underwent a change.” The boy, who lives in Singapore, is now 3 years old. “He continues to develop age-appropriate skills,” says Titus.

Shroff’s study says she injected the cells, developed from a donated embryo, into his blood, back muscles and under his skin, as well as giving them as a nasal spray. “Stem cells have an innate ability to repair and regenerate, and that is how the baby’s condition improved,” says Titus.

“There’s no obvious way in which this treatment would have worked,” says Victor Tybulewicz at the Francis Crick Institute in London. To have any effect, neural stem cells would need to be injected into the brain, he says.

“The author appears to have no idea of where [the cells] are going, or what they’re doing,” says Fisher. “It’s even worse now we know they’ve treated 14 patients, not just one.”

Titus says that the way the cells were developed means recipients don’t need immunosuppressants. But Tybulewicz disagrees. “I expect the most likely outcome of the injections would have been that they were recognised as foreign and eliminated by the immune system,” he says. More details of the biological impact of the stem cells will be revealed in a study that has been submitted for publication, says Titus.

Nutech Mediworld isn’t the only clinic offering stem cells. An analysis led by Rasko last year identified 417 unique websites advertising stem cell treatments directly to patients. Of these, 187 were linked to 215 clinics in the US. Thirty-five websites were linked to organisations in India.

Although India introduced national guidelines on clinical stem cell research and treatments a decade ago, these are not legally binding.

This article appeared in print under the headline “Clinic claims stem cells treat Down’s syndrome”