Parents Endanger Son With Embryonic Stem Cell Injections in India

Bioethics   Rebecca Taylor   May 21, 2012   |   10:36AM    Washington, DC

Parents from South Carolina have traveled to India and paid tens of thousands of dollars to have their 6 year-old son injected with embryonic stem cells. As CNN’s David Fitzpatrick and Drew Griffin report, Josh Burnaman and Stephanie Krolick have taken their son Cash to India and had former obstetrician, Dr. Geeta Shroff, “treat” his rare condition with stem cells from a now-destroyed human embryo. From the CNN story:

Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn’t have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they’ve journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

There are so many red flags flying up in this story that I truly fear for Cash’s safety. It is not just that this treatment may not have any effect, as the experts say, but it may do more harm than good. First, Dr. Shroff is using embryonic stem cells which are well known for causing tumors in animal models. In fact, the first trial ever approved in the United States with cells derived from embryonic stem cells was delayed because of safety concerns raised from the animal trials. That trial finally began in 2010 and has since been canceled. The only other trial approved in the United States using cells derived from embryonic stem cells is now underway and is still evaluating the safety of the cells.

Secondly, Dr. Shroff is a trained obstetrician, and is self-taught as a stem cell practitioner. CNN reports that the injections that Shroff’s patients receive are not as carefully administered as those being carried out in the US:

Nurses and assistants at NuTech Mediworld routinely inject patients with embryonic stem cells daily simply by sticking the needle into a patient’s back.

The routine at the clinic starkly contrasts with procedures CNN observed at a sanctioned embryonic stem cell trial at Atlanta’s Emory University, where technicians and surgeons took hours to conduct a safe injection.

Thirdly, experts say that Dr. Shroff’s approach is unorthodox:

Nevertheless, Shroff isn’t waiting for further research. She’s injecting patients with embryonic stem cells now.

“There is zero evidence for what she is doing being effective,” said Rutgers University’s Dr. Wise Young, a leading U.S. neuroscientist.

“It’s concerning no matter how you look at it,” said CNN Chief Medical Correspondent Dr. Sanjay Gupta. “Frankly it’s the complete wrong way of going about this sort of science.”

Cash’s mother also worries that the treatment may hurt Cash, but went ahead with the injections anyway and Cash’s father is skeptical of the results:

“It’s risky medical therapy,” acknowledged Krolick, who feared it would worsen Cash’s condition. “But I knew that we were going to have to do it. We did pick this clinic for a reason. I mean, we did look around, and we decided this is the place where we felt safe. She had a good track record.”

But Cash’s family has its doubters, too. The boy’s father said he still isn’t totally convinced the treatment works.

“If we had taken away the stem cells and hadn’t done it, is this where he would be naturally?” Burnaman said. “And that’s where I keep coming back to is — I’m not sure.”

I pray that Cash will not have any adverse effects from this experimental procedure. I hope he will not end up like the Isreali boy that went for an experimental fetal stem cell treatment in Russia and ended up with tumors in his brain and spinal cord. In fact, I hope that all of Dr. Shroff patients suffer no ill effects from their treatments.

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In the comments for this article, it is suggested that it was the “banning” of embryo-destructive research by the Bush Administration and the continued opposition by “militant GOP Christians” that has caused the United States to be “behind” India in embryonic stem cell treatments. The truth is that embryonic stem cell research has never been banned in the United States and George W. Bush was actually the very first president to ever fund embryonic stem cell research. Bush simply put limitations on which embryonic stem cell lines qualified for federal funds to those lines created before 2001. Those limitations were quickly dispensed by President Obama.

In truth, it is the Food and Drug Administration (FDA) that has placed any stem cell treatment, even an adult stem cell treatment with one’s own stem cells, in the same category as drug therapies. So any stem cell transplant must go through the same rigorous phase trials that a new drug would before it is approved as a treatment. The FDA is concerned not just about the safety of embryonic stem cell treatments, but also adult stem cell treatments as well. The wait for FDA approval is likely why many Americans, like Cash’s parents, are going abroad in stem cell tourism.