Winnipeg firm Regenetek issues statement explaining role in MS study

A Winnipeg-based company says it stands behind its role in a study involving an experimental treatment for multiple sclerosis, while at least three patients in Canada have brought concerns about the company's CEO to the RCMP.

Regenetek Research issued a statement Thursday in response to media reports about Doug Broeska, who had recruited MS patients to take part in the experimental and expensive study involving stem cell injections combined with the widening of veins in the neck a practice that advocates call liberation therapy. The treatments were being administered in India.

• MS patients question credentials of Winnipeg man involved in stem cell therapy
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• Stem cell researcher speaks out, defends against "inaccurate media reporting"

"Regenetek Research stands behind its role in this clinical studynamely as researchers tracking participant progress following medical treatment, with such medical treatment having been provided by third-party medical practitioners located in India," the company's statement said.

An online biography of Broeska states he is "a PhD Medical Researcher and CEO of Regenetek Inc., a Canadian Biotech Research firm working with several hospitals and clinics world-wide to develop medical procedural protocols for neurodegenerative disease management."

Broeska was the principal researcher for the experimental therapy, which was being carried out in India, but his credentials as a researcher have been questioned by some of the patients he had recruited.

Patients said they spent tens of thousands of dollars and travelled to India for the treatment, but some claimed there was little medical followup.

One patient said his MS symptoms worsened after the treatment. However, others have reported improvement and saidthey believe in the therapy.

"Regenetek Research and its researchers do not provide medical treatment in connection with the clinical study. Further, the study was never intended to replace other medical treatment and individuals were directed to stay in contact with their treating physicians," the company's statement said.

"We are scientists simply tracking the progress of participants who have chosen to attempt innovative therapy options and to have their results noted by us for scientific study."

The company added that participants will have "varying results based on a number of factors the tracking of which is a key component of the study.

Broeska has not responded to requests from CBC Newsfor an interview. The company's statement was not signed by him, and it does not directly address specific questions about his credentials.

Ottawa woman suspicious of claims

Among those who have contacted the RCMP with concerns about Broeska is Florence D'Eon, a retired nurse in Ottawa who went to Europe forliberation therapy. Shehad no involvement with Broeska's study or the clinic in India.

D'Eon said she believes in the treatment itself, but she became suspicious of claims being published online about Broeska's work and conducted her own research on him.

There was no date of birth, there was no way to trace him. FlorenceD'Eon

"The whole thing didn't make sense. The testimonials were so perfect," she told CBC News.

"They did due diligence to Dr. Doug and just in the right spots. It's almost like they were professionally written."

In an email obtained by CBC News,Broeskatold another patient that his credentials are sound and he is "competent toperform research of this type."

'There was no way to trace him'

Broeska had stated on a LinkedIn profile that he hasa PhD fromthe University of Manitoba, but the university says it could not find a record of himgraduating from there. The profile has since been removed from the site.

"The registrar's office could not find a record of a Henry Douglas Broeska graduating from the University of Manitoba," John Danakas, a university spokesperson, said in a statement.

The university also said itcould not find a record of a Doug Broeska having graduated from the institution.

The International Cellular Medicine Society, of which Broeska claimed to be a member, says it has no record of his past or present membership.

Heis not a member of the College of Physicians andSurgeons of Manitoba, officials confirmed to CBC News on Thursday.

"You see these doctors at clinics and conferences. They write papers, they write peer-reviewed publications. They have their MDs, PhD," D'Eon said.

"Doug, there was no date of birth, there was no way to trace him."

D'Eon said she took her findings to the RCMP, but she does not believe the police force has acted on them.

The RCMP has not said if it is investigating the claims.

The ethics committee at the Inamdar Hospital in India, where the experimental treatment was being performed,ordered Broeska to step down as principal investigator last month because his lack of credentials and followup "violated international ethical standards."

Patient cancelling treatment plans

Oliver Sinclair, 39, who lives with MS in Durban, South Africa, says he had paid for the treatment and made plans to travel to India on April 1 after he contactedBroeska.

"He said, 'We haven't had one person that hasn't responded positively to our treatment,'" Sinclair recalled.

Sinclair's four-year-old son helped with a YouTube video urging people to help raise $35,000 US for the treatment.

• ON MOBILE?Watch Sinclair's YouTube video

However, Sinclair said he is cancelling those plans after reading of concerns from other patients, including Lee Chuckry of Airdrie, Alta., who told CBC Newshe believes his MS worsened after undergoing the therapy.

Sinclairsaid he got his money back, but only after dozens of emails were sent.

"I certainly don't want someone else to make the same mistake," he said.

Sinclair said he still hopes to try stem cell treatment someday, but just not throughRegenetek.

University rejects joint proposal

Meanwhile, the University of Winnipeg says it has rejected a proposal for a joint research pilot involving Regenetekin which patients would go to the university for athletic therapy following their treatments in India.

The University of Winnipeg'sethics committee sent back the Regenetekproposal last week with some questions about "who Regenetek was, what type of work were they doing," said Jino Distasio, the university's associate vice-president of research and innovation.

Distasio said the committee rejected the proposalon Wednesday.

"We're quite satisfiedthat our internal processes were able to flag some issues," he said Thursday.

Distasiosaid no work had been done on the project, butthe university had already accepted $10,000 from Regenetek to hire a researcher as part of the proposedpilot. She will be working on other projects at the universityinstead, hesaid.

Manitoba Health Minister Sharon Blady said she cannot comment on specific cases, but she urged peopleto contact the College of Physicians andSurgeons of Manitobaif they believesomeone has misrepresented their medical credentials.

"It is heartbreaking and sickening to learn of individuals who are victims of fraud," she said in a statement.

"They should report this fraud to police who can investigate those who victimize people when they are most vulnerable, and lay charges if appropriate."

Regenetek's full statement

The following statement was emailed to CBC News at 6 p.m. CT on Thursday:

Regenetek Research is not available for media comment at this time as this matter has been referred to our lawyers for legal action.Regenetek Research stands behind its role in this clinical study namely as researchers tracking participant progress following medical treatment, with such medical treatment having been provided by third party medical practitioners located in India.Regenetek Research and its researchers do not provide medical treatment in connection with the clinical study.

Further, the study was never intended to replace other medical treatment and individuals were directed to stay in contact with their treating physicians. We are scientists simply tracking the progress of participants who have chosen to attempt innovative therapy options and to have their results noted by us for scientific study.

Participants will have varying results based on a number of factors the tracking of which is a key component of the study.This study is unlike, for example, standard double-blind randomized controlled drug trials, but rather is a case study series on a person by person basis.As such, the standards and protocols discussed in the media are poorly understood and have resulted in this clinical study being mischaracterized as inappropriate. In fact, much of what has been publicized is based on misinformation or misunderstanding.

As the matter is now with our legal counsel, we have been advised not to comment any further.