Oklahoma researcher says FDA crackdown could be good for stem cell treatment
Oklahoma City — The U.S. Food and Drug Administration has taken a more aggressive approach toward clinics selling unproven stem cell treatments, and that's ultimately good for the development of future treatments, an Oklahoma researcher says.
The FDA has mostly left stem cell clinics alone, but that creates a situation where patients are undergoing treatments that might be unsafe, said Paul Kincade, scientific director of the Oklahoma Center for Adult Stem Cell Research.
“What I've been afraid of is somebody's going to die and it's going to kill the whole field,” he said.
The FDA issued a warning letter to a Florida clinic for failing to ensure the cells it used weren't contaminated by bacteria or viruses, and seized several vials of smallpox vaccine from a California clinic using it in its stem cells preparations. The vaccine couldn't cause smallpox, but could lead to other serious reactions when given to people with compromised immune systems, according to the FDA.
Increased enforcement doesn't mean that patients can now assume stem cell clinics are safe, however. Many may not even be using true stem cells, which require a complex process to make, Kincade said.
“The phrase ‘one step ahead of the sheriff' comes to mind,” he said.
Stem cells are essentially precursors that develop into other types of cells. Embryos in the early stage of development have large numbers of stem cells, but those are rarely used because some people object to destroying an embryo. Adults have stem cells in their bone marrow, intestines and skin, which allow the body to replace those cells throughout a person's lifetime, Kincade said.
A few years ago, however, scientists developed a process to essentially reprogram an adult cell to return to a state like an embryonic stem cell, Kincade said. Through the right processes, scientists could theoretically coax stem cells into becoming whatever type of cell a patient needed to treat a disease, such as pancreas cells to produce insulin for people with diabetes or brain cells making dopamine for people with Parkinson's disease.
It's a long way from practical application, however, because scientists have to sequence the DNA of every cell to ensure it hasn't mutated to cause cancer, Kincade said. The costs can easily run as high as $2 million.
Commercial stem cell clinics typically don't go through that process, however, Kincade said. Usually, they take cells from a patient's fat, spin them in a centrifuge until they separate, and inject the result into a patient. Some people might feel better from a placebo effect, but the treatment itself isn't likely to have any benefit, he said.
“Why should it fix your heart?” he said. “You don't make heart from fat stem cells.”
People tend to underestimate the risks of an experimental procedure when they face a life-changing disease, and enthusiasm for stem cells has outrun understanding, Kincade said. For example, he's seen cosmetics that claim to be made with fruit stem cells — which have no use for humans, he said.
Patients “are desperate, and we understand that,” he said. “Too often, people are set on that stem cells are going to fix it.”
The International Society for Stem Cells Research offers some guidelines if you are considering stem cell treatment:
• Patient testimonials are a red flag. They may not reflect actual benefits from the treatment, and the people in the photos may not be real patients.
• If a clinic offers to treat multiple diseases with the same cells, be suspicious. Diseases that aren’t related will need different treatments.
• The clinic should be able to clearly explain how it obtains the cells, and what process it follows.
• Other than bone marrow transplants, nearly all procedures involving stem cells are experimental. Legitimate studies will include consent forms that explain the patient may not benefit, or could even be harmed. Consent forms shouldn’t release the researcher from legal liability for negligence, and staff shouldn’t claim there are no risks.
• If you have to pay to participate, the clinic likely isn’t running a legitimate clinical trial.