Ten heart failure patients who received controversial fetal stem cell injections are all showing signs of rapid recovery three months after the treatment, surgeons who performed the first-time procedure said this weekend.
The treatments, which took place in Ecuador, have raised sharp ethical questions over the mere use of fetal stem cells, which some oppose on principle. But the case has also raised new concerns over rushing forward with unproven stem cell treatments.
Frederico Benetti, one of the surgeons on the study and pioneer of so-called beating heart surgery presented the data on Saturday at the International Society for Minimally Invasive Cardiothoracic Surgery annual meeting in New York.
“We need to be very cautious because this is the first time in the world these cells are implanted into the heart of patients,” Benetti said. “We are very fortunate all patients are alive at three months. It is safe and that is the most important thing. We also demonstrated the patients improved a lot.”
Benetti has also had success with cells taken from bone marrow. But the fetal cells appear to be more effective, he said. “The change we observed in fetal cells in one week we saw in autologous cells after 20 days (to) one month. Clinically the patients look so much better. Implanting fetal cells is so much more powerful.”
The results may lend credibility to a Barbados clinic called the Institute for Regenerative Medicine, which supplied the cells and funded the study. The island clinic offers fetal stem cells for a $25,000 fee for indications from aging to spinal cord injury.
The clinic is controversial according to some scientists because the fetal cell therapies have not been proven safe and effective by controlled clinical trials necessary for approval in the United States and other Western countries.
Barnett Suskind, CEO of the Institute for Regenerative Medicine, said he agrees therapy using the cells needs more study. But he is confident in the safety of the treatments based on data gathered by Soviet scientists who first developed the treatments in the ’80s.
“We spent four months looking at the documents and I had Leonard (Makowka, the company’s senior scientific consultant) go through them and after reviewing approximately 1,700 case studies going back 10 years, we saw no adverse side effects,” Suskind said. “We decided we can conclude it’s safe with that size of data.”
Scientists are tough to convince, however, without evidence in the form of controlled, published clinical studies.
“I am skeptical of anyone who goes straight to patients off-shore and does not publish animal data first and then go through rigorous screening in this country to conduct a proper clinical trial,” said Evan Snyder, program director in stem cells and Regeneration at the Burnham Institute in La Jolla, California. I regard them as intellectually weak and reckless at best and cowards and exploiters at worst.”
Snyder said he is willing to keep an open mind once the scientists describe the cells in detail and provide more data with double blind controls.
He and his colleagues reported in December 2004 in the Proceedings of the National Academies of Science that stem cells can prevent cells from dying as well as decrease inflammation and scarring. The fetal cells could be having a similar effect, he said, but until the data is published he remains skeptical.
“Until they are published in a peer-reviewed mainstream journal, they do not exist,” Snyder said.
The patients in Benetti’s trial were injected with up to 80 million fetal cells donated by consenting women who had undergone elective abortions or spontaneous miscarriages, the researchers reported. The women were not compensated, and the cells were screened for pathogens. The injections increased the patients’ heart-pumping efficiency 41 percent on average, the surgeons reported. The distance the patients could walk nonstop increased by 72 percent. After three months, they could walk 16 percent further.
Advanced heart failure is usually fatal. The patients’ only hope would have been heart transplantation, which is rarely performed in Ecuador, where the surgeries took place at the Luis Vernaza Hospital in Guayaquil.
A handful of similar clinics are operating in underdeveloped countries, including Medra in the Dominican Republic. Suskind’s Institute of Regenerative Medicine, however, may be one of the few, if not the only off-shore clinic recording data with at least the intention of publishing in scientific journals.
Dr. William Rader, Medra’s medical director, did not return repeated phone calls.
The Barbados institute intends to fund trials in spinal cord injury, diabetes and diabetic retinopathy over the next year, Suskind said.
