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FDA concern over unproven treatments

FDA concern over unproven stem cell...

RANCHO MIRAGE, Calif. - Three years ago, three separate doctors told Jack Jennings, 80, that he would have to replace both shoulders. Then he read an article about stem cells.

Jennings is one of the thousands of Americans paying thousands of dollars to try stem cell therapy for issues as diverse as erectile dysfunction, facial rejuvenation, and chronic pain.

This treatment is available at a growing number of clinics across the country, including California Stem Cell Treatment Center in Rancho Mirage.

Jennings' doctor, Elliot Lander, is also a pioneer in emerging therapies for more serious ailments.

HOW IT WORKS

Dr. Lander takes a little bit of fat from under the skin and extracts the patient's own stem cells from the fat. 

"We can use them to do what stem cells do, which is find things and repair them," explains Lander.  "Whether it's age-related degeneration, toxins, drugs, diseases, trauma, whatever it is in your body that needs repair, these cells are capable of doing it.  But they didn't come from a bottle.  They came from a doctor, working on a patient in a room, over a one and a half hour period."

Lander says the process virtually eliminates the need for pharmaceutical drugs.

"We're able to give the patients back something that's under their skin, that's not really available because it's locked in a collagen matrix, and we just kind of loosen things up and make it bioavailable, and we give it to them and we've created a cell therapy.  A custom self-therapy for that patient that has their DNA and their own pair factors that is sometimes helpful, sometimes not, sometimes astonishing.  But it's something we can do for patients that they can use their own bodies to help themselves, and it's very compelling. and it's also a very big threat to certain industries that rely on our failure for them to succeed."

Dr. Elliot Lander received a standing ovation at a hearing for FDA guidelines in Sept. 2016.  Of the hearing, he says "The industry has put enormous pressure on the FDA to regulate these minor surgical procedures that are done in physician offices as a drug production and manufacturing which has super stringent requirements for sterility (beyond surgical sterility). Such arbitrary rules essentially outlaw the procedures if guidance language is approved."

But it was Lander's cancer trial through the "cell surgical network" that got the attention of the FDA. In August, the FDA seized five vials of what they called a smallpox vaccine administered "as part of a potentially dangerous and unproven treatment."

CBS Local 2's Brooke Beare investigated the claims and spoke with Dr. Lander about the work being done by his team, and stem cell researchers around the world.

"I think people got scared and overreacted a little bit," Lander said.

When pressed about the FDA implying that his work was not safe, Dr. Lander said, "These vials contained a drug that's already FDA approved for use in children and adults and has been used on over 100 million people."

Lander continued, "In our particular trial we treated 26 patients, and no one was harmed by the virus, so the safety is actually incredible and we've had some amazing results."

But the FDA's investigation underscores the dilemma for millions who are looking for a cure.

"You always get approached by people, try this,try this try this," said Kristin Sherman. 

Sherman's daughter is actively fighting stage four relapsed neuroblastoma.

"We've had, use this supplement, buy this vitamin, buy an $1800ph water balancer. The real popular one right now is medical marijuana," Sherman said. "People will do anything. Anything to give them time to save their family. At any cost."

And the process doesn’t always work because most treatments are not FDA approved. There's no government data about how frequently things go wrong, but the government agency pointed us to a case in Florida where one stem-cell patient went blind, and others suffered detached retinas.

"We know what works and what doesn't work. If something is dangerous or ineffective we know within minutes and we can stop it," Lander said.

Lander says of the more than 7,000 patients treated, they've had only 4 adverse events. With only one directly due to stem cells.

Henry Tsai, a professor at UCSD and an oncologist at Eisenhower Medical Center, believes the stem cell treatment industry should be regulated by the FDA.

Tsai says there’s no strong science for stem cells yet.

"Anyone could get something and feel good about it and tell you about it but it may or may not be working," Tsai said.

UC Riverside School of Medicine's Doctor Paul Lyons believes stem cells will be central to treating many ailments, eventually.

"The question is when do you want to get on that train," Lyons said.

"You can't just marginalize an entire science and say that's not important, that's bad. These clinics are unregulated so they have to go away," Lander said. "That would actually be a great disservice to humanity because we're providing medical care for people who otherwise might have either limited options or in many cases, no options."

Lander says he is transparent about all his data but that patients should do their due diligence.  

WATCH: You should find out THIS before entering any clinical trial

WATCH: Red flags to look for before undergoing stem cell therapy


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