What we know about the company
With offices on Chevrier Boulevard, Regenetek is a "private, not-for-profit medical research company" that recruits people suffering from multiple sclerosis and, more recently, amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, for a clinical trial based out of Pune, India.
Regenetek touts its combination therapy -- a combination of the neck vein angioplasty pioneered by Paolo Zamboni in 2009 and a stem-cell treatment in which bone-marrow cells from the patient are extracted, expanded in a lab and reinjected. Zamboni's treatment has been widely challenged as ineffective in the long term, but stem-cell treatments do hold some promise.
Though nearly all ethical rules, including those in India, say patients ought not pay for clinical trials, Regenetek charged people between $35,000 and $45,000 for the combination treatment.
Since 2012, roughly 70 people have travelled to India for the treatment. Some are from Manitoba, but many live elsewhere in Canada or abroad. Doug Broeska, known to patients as Dr. Doug, claimed the treatment was "curative" and that every patient saw significant benefit from the treatment. Many did, but, a Free Press investigation found at least a half-dozen patients who saw no effects from their treatments in India. They are angry and believe they have been duped.
Until recently, Broeska was the principal investigator on the clinical trial. He claimed to have a BSc and a PhD, first from the University of Manitoba. Then he claimed to have a PhD from "Brightland University." He does not hold any degree from the U of M, and Brightland University does not exist. Broeska also claimed to be a member of the International Cellular Medicine Society and to have approval for his clinical trial from "several" ethical panels. Neither is true.
Last month, the ethics committee at the Pune hospital asked Broeska to step down as principal investigator. The ethics committee raised several serious issues -- that Broeska's lack of credentials and followup "violated international ethical standards," that the diagnosis of the diseases of some patients had been manipulated and that some patients were being "enforced/blackmailed to stop certain life-saving medicines" without scientific justification.
Broeska and Regenetek have fallen through many regulatory cracks. Health Canada has a complaint on file, though little has happened. Three people have complained about Regenetek to the RCMP. It's not clear if they are investigating. The College of Physicians and Surgeons of Manitoba has been hands off. But, the Canada Revenue Agency has just launched an investigation.
The University of Winnipeg was about to begin a research partnership with Regenetek to study athletic therapies on patients who'd had the stem-cell treatment. The U of W cut ties with the company this week.
Positive experiences with Regenetek
More than half-a-dozen patients, including Kathleen Jaynes and several others interviewed by the Free Press, say they saw no improvements to their illness following the stem cell treatment. The Free Press also spoke to five others, supporters of Doug Broeska, who said the therapy prompted real improvements.
"The people with good results should be standing up and speaking up for him," said Jayne Thomas, who has had MS since she was a teen.
After she travelled to India in the fall of 2013, Thomas said she saw improvements to her speech, hearing and endurance. She says she has enough strength and muscle control to swing her leg forward on her own, something she could not do before. She called the results "fantastic." Now, she says Regenetek is paying for her physiotherapy, which costs $1,300 a month.
"If it wasn't a legitimate trial, why would they be paying for my physio?" Thomas said, from her home in St. Catharines, Ont.
Linda Friesen of Tisdale, Sask. is one of the most outspoken supporters of "Dr. Doug" and his treatment. Her remarkable recovery has been cited by several patients as one reason they decided to cobble together the thousands of dollars and travel to India.
Friesen said Broeska changed her life. She was destined for a motorized wheelchair before she had the stem cell therapy in the fall of 2013 and now she's walking, her arm function is restored and her vision has improved.
"I was going downhill fast and had no hope," she said. "Am I cured? No. Am I getting better? You betcha. Do I owe everything to going to India? You bet."
Both Thomas and Friesen said they had no concerns Broeska falsified his credentials or that Regenetek may really be offering medical tourism instead of approved clinical trials. Friesen told CBC News that the company has paid her to help other MS patients in Saskatchewan with their paperwork.