Controversial Stem Cell Treatment Attracts Thousands

HANGZHOU, China, Feb. 15, 2008— -- On the top floor of the Xiaoshan Hospital, just beyond the bustle of Hangzhou, China, in a city Marco Polo once called "the finest and noblest in the world," a group of Americans are in search of a miracle.

Flying in from as far away as Tennessee and Pennsylvania, many of these Americans have traveled to China with disabilitating conditions such as spinal cord injuries and cerebral palsy in hopes that Chinese businessman, Sean Hu, may hold the key to their recovery.

Hu and his company, Beike Biotech, believe they can offer these Americans what they can't get at home: the promise of stem cell therapy.

"Stem cells is going to be very big," Hu said. According to Hu, his group was one of the first to apply stem cells clinically.

Using stem cells harvested from umbilical cord blood (UCB), Hu said his company has treated over 2,000 patients since 2005. They claim an 85 percent rate of improvement in a variety of conditions, from spinal cord injuries to autism.

Seemingly impressive results are posted online by either Beike or former patients, such as a young boy who suffered seizures from cerebral palsy, and who suddenly became relaxed. Or a young girl named Rylea Barlett from Missouri, born legally blind, who is now apparently able to see.

The abundance of alleged success stories online led to an influx of Americans, many coming to China for the first time, in search of a cure.

Including Paul Flynn, a 43-year-old from Colorado Springs, Colo. whose son came across Beike's Web site while researching a project for school.

Flynn had never been to China — he didn't even have a passport.

"The longest trip I've even took was probably three hours," he said.

'Like Being Drunk All the Time'

Flynn has Ataxia, a genetic disease that causes progressive deterioration of motor skills, vision and speech. Once hands-on and active in his prime, Flynn now struggles to navigate his own home.

"It's like being drunk all the time," he said. "It starts out with a six-pack and then you get a 12-pack, and it just gets worse. You can't walk with a cane, because you don't know which way you're going to fall."

Flynn's symptoms began seven years ago. His two sons, Michael and Matthew, have both grown up watching their father's condition worsen.

"Hard to believe how it takes effect like that," said Michael. "I remember when he used to do a whole bunch of stuff, help around the house, work on stuff, and now, it's just getting harder and harder for him to do some of that stuff."

Matthew added, "The most that's affected with us is doing things in public, because it gets difficult, because the American community is ignorant, and they'll see someone stumbling, and they'll just think they're drunk."

It's never been lost on the sons that they, too, might someday develop the crippling disease that runs in Flynn's family.

It confined Flynn's mother to a wheelchair, and eventually affected his sister. Both died from the complications.

Now, Flynn's brother Bob is in a wheelchair. For Flynn, time is running out. Ataxia has no known cure.

When asked whether he wonders "Why me?" Flynn choked up.

"Well, not all the time, but you know, like, why do I have to hang out inside the truck. Things like that, you know? And I like to walk down to the creek, you know, and do some fishing, but I can't get down the damn hill … to go fishing. You know, things like that. Gotta deal with what the cards deal you with."

Then, one day when he was online, the Flynns came across Beike's patient blogs. One story featured an Ataxia patient who had a similar labored walk, and then showed the result after stem cell injections.

Is Treatment Worth the Risk?

In August, Flynn headed off to China and expecting to pay upwards of $40,000 for treatment. His oldest son Michael accompanied and supported his dad during his first trip out of the country.

"I know it's going to work, and I keep telling Paul that," said Flynn's wife Teresa. "'See yourself walking.' He's going to come back a new man."

Flynn's visit was yet another example of what's been dubbed stem cell tourism, fueled by foreign clinics offering stem cell treatments.

It is a trend that worries Dr. George Daley, an associate professor at Harvard Medical School, and current president of the International Society for Stem Cell Research.

"There are clinics now being set up all over the world," Daley said. "There is a clinic in Bermuda, there is a clinic in Barbados, there are clinics in Eastern Europe."

According to Daley, these clinics are created in the wave of hype around the promise of stem cells.

"The fact is, that there are many desperate patients out there who don't want to wait for the slow process of medical research and medical advancement," he said.

Flynn is willing to take that risk.

"When I first got off the plane, it was like … I'd hate to say it … but it was like a Jackie Chan movie," Flynn said. "There were scooters, three-wheel scooters with stuff piled on."

There was, however, no time to reflect. Flynn's treatment began almost immediately. Beike's self-described "holistic" approach begins with physical therapy, to gauge the extent of Flynn's Ataxia, and then acupuncture to relieve and stimulate his muscles. All of this supplements his main treatment: the injection of stem cells that must be flown in fresh in a cooler from one of 10 labs Beike operates around China and quickly rushed back to the patients at the hospital.

On the day of the injection, Flynn is wheeled into the operating room, where he is under local anesthesia, and the doctor removes spinal fluid, replacing it with a cocktail of, what Beike says, contains 10 to 15 million stem cells harvested from cord blood.

Improved Balance, Strength

Paul signed up for a total of six doses of stem cells, five spinal injections and one IV.

"After they give you the stem cell treatment in the spine, it tends to set you back three days," Flynn said. "Therefore, I can feel the weakness in my body coming out. I don't know what happened, they're working or something."

Then, he began to feel better.

"By the fourth day, I start getting muscle back, strength back, and start climbing back up the ladder again," he said.

Since he started having the injections, he says his strength has increased, and so has his balance.

According to the Beike doctors, the stem cells target the areas in need. In Flynn's case, Ataxia has damaged cells in his cerebellum, the part of the brain that controls motor skills.

But critics of such procedures say they may be jumping the gun, especially in how they are using umbilical cord stem cells.

"To say that cord blood stem cells are ready for primetime, ready for interventions in neurodiseases or heart diseases, or anything outside the blood, is really the height of speculation," Daley said.

In the United States, cord blood stem cells have only been used to treat blood-related diseases, such as leukemia.

Yet, on Beike's Web site, treatable conditions run the gamut: autism, Amyotrophic Lateral Sclerosis (known as "Lou Gehrig's disease"), Parkinson's disease and Optic Nerve Hypoplasia.

Hu disagrees with U.S. experts who say there is no evidence that umbilical cord stem cells can help people with the sort of neuromuscular diseases that he is treating.

"That's wrong," Hu said. "There's no problem [with] that. And there are many, many publications."

Daley, however, is skeptical.

"I am familiar with a couple of publications that have reported that umbilical stem cells, UCB stem cells, have been used in animal models of stroke," he said. "These are incredibly preliminary types of experiments. They would, by no means, establish enough of a proof of principal to justify going into human patients with these kinds of therapies. I would be very suspicious."

A Beike spokesperson told "Nightline" in response that, "If you get too caught up on the controlled study subject, and the difficult process of getting scientific data from China published in Western journals, you are going to miss the story, though. For most of the patients out there, getting improvement in their condition takes precedence over reading a double-blind study."

'Improvement' vs. Clinical Results

Hu described the high costs of doing a clinical trial, and pointed out that many patients are eager for treatment, regardless of whether it has been clinically proven.

This reasoning worries Daley.

"I'd be very concerned if a company is doing clinical interventions under the promise of medical cures, in a way where they are not gathering data in a reliable, responsible, controlled manner that's going to allow for the rest of the medical community to learn from it," he said.

But according to Hu, most of the patients do get improvements from the treatment.

"We are not talking about cure, but improvements," he said.

The mention of improvements, however, was merely "a matter of semantics" to Daley, especially if Beike charges patients tens of thousands of dollars.

"I think that this is highly unethical. Certainly does not meet the medical standards that we would practice here in the United States," he said.

Despite the running debate, Flynn stands by his decision. In October, he returned to China for a second treatment. And this time, his older brother Bob came along.

Seeing Is Believing

Flynn and his family are convinced by what they see, and even sent "Nightline" video diaries after their October trip.

On screen, Flynn illustrated his progress.

"It's a bunch of little things that are starting to reconnect together, like I can do this now." Flynn held his hand up, and separated his middle finger from his ring finger. "I sure wasn't able to do that earlier, put my fingers out like [a Star Trek] Vulcan.

"Little things like that. I can jump now, which I couldn't jump earlier. I can jump now, little frog hops, which requires all the contraction and releasing and coordination of all of your leg muscles all at once. So, just little things like that. Squatting, I can squat a little better now without falling over."

His wife, Teresa, has also taken note. "I've noticed a lot of improvement in his walk, his speech, his overall sense of well being," she said.

Beike tells their patients not to expect immediate results, and that it may take a while for the stem cells to work.

As the Flynns wait, Michael, who has accompanied his dad throughout the process, tried to put his father's journey into perspective.

"I feel that stem cells are only half the cure. The other half of the cure, you have to put in yourself. You have to keep doing [physical] therapy, keep getting stronger," he said.

For Flynn, it's nothing short of a life-changing experience.

"Because I had to come halfway 'round the world to get what I needed. Because they won't offer it in the U.S. I had to come all the way over here," Flynn said. "It'll take time, it'll take a lot of hard work, but basically, it's been seven years of getting bad. Six months? Hell, there's nothing to it right?"