Hockey legend Gordie Howe's recovery following experimental stem cell treatment in Mexico has buoyed hope for stroke victims, yet raises questions about the effectiveness of clinical trials in foreign countries.

Toledo radiologist Dr. Murray Howe has described his father's return from the brink of death as "miraculous." The elder Howe participated in a clinical trial by Novastem, a regenerative medicine company, at Clinica Santa Clarita in Tijuana. But critics in the scientific community have questioned whether the treatment caused Howe's improvement, and raises ethical concerns about Novastem.

Paul Knoepfler, an associate professor of cell biology at the University of California-Davis School of Medicine, is among scientists skeptical about the success of the treatment for Gordie Howe, who also has dementia. A prolific blogger, Knoepfler has been named among the top 50 most influential in the stem cell field.

"It's a little bit of a red flag if you have to travel for treatment outside the U.S.," Knoepfler said. "Everyone obviously wishes him the best; I certainly do. ... But the real question is whether the stem cell treatment is the reason he seems to be doing better — there's some natural healing that can occur.

"It's just sort of assumed that there is a 100 percent correlation between that treatment and him getting better, and that's something we don't know."

One thing that sets Stemedica apart from other stem cell companies, Knoepfler said, is that the company has U.S. Food and Drug Administration-approved trials going on in the United States. Among roughly 100 stem cell trials underway in America by various companies, few are approved by the FDA, the government agency responsible for approving drugs and medical procedures.

Obtaining FDA approval for a clinical trial is an arduous and time-consuming process, and it's not unusual for reputable stem cell companies to conduct trials outside the country, Knoepfler added.

About 800,000 people in America have a stroke each year, making it a major cause of adult disability, according to the federal Centers for Disease Control and Prevention. One American dies from a stroke every four minutes, making it the fourth-leading cause of death, according to the CDC.

Close to death

A Hall of Famer who played on four Stanley Cup championship teams in Detroit, Howe, 86, was severely disabled by a stroke on Oct. 26. A blood clot obstructed a blood vessel to Howe's thalamus, the part of the brain that relays motor and sensory signals to the cerebral cortex. The left side of the thalamus was damaged, affecting Howe's speech and the right side of his body.

Howe was wheeled into Clinica Santa Clarita, a Mexican distribution site for Stemedica Cell Technologies Inc.'s stem cell treatment, on Dec. 8. He was unable to walk or feed himself and could barely speak, according to his son, Murray. A feisty Gordie Howe walked out of the clinic two days later, with more fluent speech and renewed vitality.

At a celebrity dinner Friday in his native Saskatoon in central Canada, video footage showed Howe was able to slowly walk to a transport van and the dinner stage as well as acknowledge with a smile comments from an interviewer and a crowd member.

Family members said they believed the hockey legend was close to death in the days leading up to his trip to Mexico.

"For the first two weeks (after the stroke), he made some modest improvements to the point where he could stand and take a couple of steps with his walker, and mumble a few words, but from then on out it was pretty much a downward spiral," Murray Howe said.

Then Murray Howe received a phone call from Dave McGuigan, vice president of marketing at Stemedica, a San Diego-based stem cell manufacturer. McGuigan formerly worked for the Detroit Red Wings and was acquainted with the Howes.

Stemedica had been awarded a U.S. patent on Oct. 1 for a method of treating ischemic stroke patients with multiple stem cell lines. The cells are administered by an injection into the spinal cord through a lumbar puncture. Clinical trials were about to begin in Mexico.

"They were hoping that these cells would be able to do something for my dad," Murray Howe said. "I explained to them how bad off my dad was, that I couldn't imagine it would do anything for somebody that was this far along."

During two days of treatment at Clinica Santa Clarita, two types of stem cells from third-party donors were administered by an anesthesiologist licensed to practice medicine in Mexico. Neural stems cells, or brain cells, were administered on Dec. 8. The next day, Mesenchymal cells, which differentiate into bone, cartilage and other parts of the musculoskeletal system, were injected.

Howe, who was the first participant in the clinical trial, received his treatment at no charge, said Rafael Carrillo, president of Novastem, the only company licensed to study the use of Stemedica's stem cell products in Mexico. Future participants will pay about $30,000, Carrillo said, and the company hopes to recruit 30 participants, including Howe.

Treatment fees questioned

Dr. David Gorsky, a surgical oncologist at the Detroit-based Barbara Ann Karmanos Cancer Institute, has blogged prolificly against studies conducted outside the U.S. clinical trial system. He says it's unethical to charge for participation in a clinical trial.

"If Gordie Howe was treated as part of a clinical trial, then Novastem should have treated him for free because if it is running a clinical trial, it should treat everyone on the trial for free," Gorsky wrote on the Science-Based Medicine website. "That's the way it's done ethically."

Asked about the fees, Carrillo said, "We're not a Pfizer," suggesting the pharmaceutical giant is in a better financial position than tiny Novastem to offer clinical trials for free.

"We are definitely not making money on the patient; this treatment probably cost $50,000," Carrillo added. "It's a lot of money, but that's what it costs, especially at first, and with time, the cost will go down."

Carrillo said the FDA has approved clinical trials for similar treatments of patients whose strokes occurred six months previously. But both Carrillo and Murray Howe said Gordie Howe might not have survived a six-month wait.

Asked if he thinks the FDA should change its processes to let Americans more quickly access treatments in the United States, Murray Howe said he does not disagree with the agency's requirements.

"As a physician who works in a medical legal environment on a daily basis, I understand the FDA's caution," Howe said. "I understand being conservative, and I don't fault the FDA right now.

"I'm so glad that there are options for people out of the country," he added, noting that there are good hospitals and bad hospitals even within the United States.

"Every health care facility is an individual thing," Howe said. "I was blown away by the quality of this one clinic."

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