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Fallout from fake credentials

Winnipeg Free Press - PRINT EDITION

By: Mary Agnes Welch and Melissa Martin

Posted: 01/15/2015 3:00 AM | Comments:

The University of Winnipeg has axed a joint project with Regenetek Research, the local company selling stem-cell treatment to people with multiple sclerosis.

The move by the university's ethics committee came Wednesday, hours after the Free Press published its investigation into Regenetek owner Doug Broeska's credentials and his clinical trial.

The university's move puts an end to Broeska's repeated claim he was about to launch a study with U of W's kinesiology faculty to track and test some of the 70 patients who paid Regenetek as much as $45,000 for experimental stem-cell transplants in India.

"The patient outcomes have been so significant that we will soon be announcing a companion study with the University of Winnipeg," Broeska told a prospective patient in an email obtained by the Free Press. "Dr. Glen Bergeron, assistant dean and one of Canada's foremost physiotherapeutic specialists (head physiotherapist, Canadian Olympic Team) has confirmed our evidence based on patient observation... and would not have contemplated such a study if our patient/subjects had not demonstrated neural pathway restoration as a result of their therapies."

Winnipeg-based Regenetek and the U of W signed a preliminary letter of intent last spring. The company even gave the U of W $10,000 to hire a young researcher. She moved to Winnipeg from Waterloo, Ont., and began work in November in anticipation the joint research project would soon win ethics approval from the university's review panel.

Last week, the U of W's ethics committee sent the proposal back to Bergeron with questions and concerns. On Wednesday morning, the committee rejected the joint application outright.

Bergeron did not reply to requests for comment. Instead, Jino Distasio, the U of W's associate vice-president of research and innovation, said the university takes the health of study participants extremely seriously and already harboured concerns about the project.

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Fallout from fake credentials

U of W cancels proposal for joint research study

Winnipeg Free Press - ONLINE EDITION

By: Melissa Martin and Mary Agnes Welch

Posted: 01/15/2015 2:00 AM | Comments:

The University of Winnipeg has axed a joint project with Regenetek Research, the local company selling stem-cell treatment to people with multiple sclerosis.

The move by the universitys ethics committee came Wednesday, hours after the Free Press published its investigation into Regenetek owner Doug Broeskas credentials and his clinical trial.

The universitys move puts an end to Broeskas repeated claim he was about to launch a study with U of Ws kinesiology faculty to track and test some of the 70 patients who paid Regenetek as much as $45,000 for experimental stem-cell transplants in India.

"The patient outcomes have been so significant that we will soon be announcing a companion study with the University of Winnipeg," Broeska told a prospective patient in an email obtained by the Free Press. "Dr. Glen Bergeron, assistant dean and one of Canadas foremost physiotherapeutic specialists (head physiotherapist, Canadian Olympic Team) has confirmed our evidence based on patient observation... and would not have contemplated such a study if our patient/subjects had not demonstrated neural pathway restoration as a result of their therapies."

Winnipeg-based Regenetek and the U of W signed a preliminary letter of intent last spring. The company even gave the U of W $10,000 to hire a young researcher. She moved to Winnipeg from Waterloo, Ont., and began work in November in anticipation the joint research project would soon win ethics approval from the universitys review panel.

Last week, the U of Ws ethics committee sent the proposal back to Bergeron with questions and concerns. On Wednesday morning, the committee rejected the joint application outright.

Bergeron did not reply to requests for comment. Instead, Jino Distasio, the U of Ws associate vice-president of research and innovation, said the university takes the health of study participants extremely seriously and already harboured concerns about the project.

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U of W cancels proposal for joint research study

New test helps guide treatment for bone marrow transplant patients with graft vs. host disease

Innovative scoring system uses 'Ann Arbor GVHD score' to better predict how patients will respond, minimize side effects

ANN ARBOR, Mich. - A new test can guide treatment for patients with graft versus host disease (GVHD), an often life-threatening complication of bone marrow and stem cell transplants, according to research from the University of Michigan published in Lancet Haematology this month.

Patients with fatal blood cancers like leukemia often need bone marrow or stem cell transplants to survive. But one of the most common and serious side effects that patients face is graft vs. host disease: when a patient's new immune system from the transplant (the graft) attacks the patient's healthy tissue (the host).

Most GVHD starts out as mild, but in two-thirds it eventually becomes severe. The treatment for severe GVHD is high doses of medications that knock out the immune system. But doctors have to be careful with drugs that further weaken a newly transplanted immune system, because they increase the risk for serious and life-threatening infections. Until now there has been no test to determine which cases of GVHD will become severe, so treatment is often delayed until the GVHD worsens.

The study's lead author, John Levine, M.D., of the University of Michigan's Blood and Marrow Transplant Program and his colleagues studied almost 800 patients from the US and Germany to develop and validate a new scoring system. The Ann Arbor GVHD score uses the levels of three proteins in the blood (TNFR1, ST2, and REG3a) to determine whether the patient should be treated right away or not and how intense the treatment should be. Patients with Ann Arbor 1 GVHD usually don't need treatment while patients with Ann Arbor 3 GVHD often don't respond to standard treatment and should be considered for clinical trials.

"We often have to treat all patients with GVHD alike with very high-dose steroids, because the severity of symptoms at the disease's onset don't help us predict how sick the patient will get. But this new scoring system will help identify patients that need a different approach, says Levine, who also is clinical director of the Pediatric Blood and Marrow Transplantation program at C.S. Mott Children's Hospital.

"And it can help us with patients with lower-risk GVHD who we may be over-treating. These scores can help us find a better, more individualized fit for our patients as soon as their disease is diagnosed," says Levine, who is professor of pediatrics at the University of Michigan Medical School.

Around half of patients who get a bone marrow transplant will develop GVHD, which can be lethal if it can't be controlled.

"Our goal is to offer personalized care. Doctors have struggled with individualizing therapy for each patient, but there's been no new therapy for GVHD in more than 40 years. So this new scoring system gives us another tool to better take care of our patients," Levine says.

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New test helps guide treatment for bone marrow transplant patients with graft vs. host disease

New device allows for manipulation of differentiating stem cells

Electroporation is a powerful technique in molecular biology. By using an electrical pulse to create a temporary nanopore in a cell membrane, researchers can deliver chemicals, drugs, and DNA directly into a single cell.

But existing electroporation methods require high electric field strengths and for cells to be suspended in solution, which disrupts cellular pathways and creates a harsh environment for sensitive primary cells. This makes it nearly impossible for researchers to study the cells naturally, in a setting that encourages the cells to continue differentiating and expanding.

A Northwestern University collaboration has developed a novel microfluidic device that allows for electroporation of stem cells during differentiation, making it possible to deliver molecules during this pivotal time in a cell's life. This provides the conditions needed to study primary cells, such as neurons, opening doors for exploration of the pathogenic mechanisms of neural diseases and potentially leading to new gene therapies.

Developed by Horacio Espinosa, the James and Nancy Farley Professor of Manufacturing and Entrepreneurship at the McCormick School of Engineering, and John Kessler, the Ken and Ruth Davee Professor of Stem Cell Biology at the Feinberg School of Medicine, the localized electroporation device (LEPD) can be applied to adherent cells, which are grown on an artificial substrate as opposed to free-floating in a culture medium and are able to continue growing and differentiating.

"The ability to deliver molecules into adherent cells without disrupting differentiation is needed for biotechnology researchers to advance both fundamental knowledge and the state-of-the-art in stem cell research," Espinosa said.

"Non-destructive manipulation of cells over time and in the correct environment is a key enabling technology highly needed within the biology and medical research communities," Kessler said.

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Supported by the National Science Foundation and the National Institutes of Health, the research is described in a paper published in the September 10 issue of Lab on a Chip, the journal of The Royal Society of Chemistry, and was also highlighted on the journal's back cover. Other authors on the paper include Wonmo Kang, Juan P. Giraldo-Vela, Shiva Nathamgari, Tammy McGuire, and Rebecca McNaughton.

The team fabricated the LEPD by employing a commonly used polymer for rapid prototyping of microfluidic devices for biological applications. It consists of circulation microchannels beneath a cell culture chamber made up of a perforated substrate and built-in electrodes. Although the main applications of the initial research examined neurons, the device is a general tool that can be used for any type of adherent cell.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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New device allows for manipulation of differentiating stem cells

New Approach, New Hope: $12M New York State Investment Will Fast-Track Innovative Roswell Park Research in Ovarian …

Buffalo, NY (PRWEB) January 14, 2015

Researchers at Roswell Park Cancer Institute (RPCI) have received a prestigious grant of nearly $12 million from the New York State Stem Cell Science Program (NYSTEM) to develop new therapies for advanced ovarian cancer. The four-year, $11.9 million grant to RPCI is one of three new state awards totaling $36 million to support innovative approaches for developing stem-cell based therapies for diseases that are notoriously hard to treat. The clinical need for new treatments is dire, as advanced ovarian cancer is an aggressive and typically fatal disease.

Using an approach known as adoptive T-cell therapy, the Roswell Park team, led by Kunle Odunsi, MD, PhD, FRCOG, FACOG, Chair of the Department of Gynecologic Oncology, M. Steven Piver Professor of Gynecologic Oncology and Executive Director of the Center for Immunotherapy, will take stem cells from patients blood, re-engineer them and infuse the reprogrammed cells back into those patients. Once inside the patients body, the re-engineered stem cells become a continuous, potentially lifelong source of cancer-fighting immune cells. This strategy has proven successful in preclinical studies as a way to not only eradicate existing cancer but to prevent new cancer cells from developing.

New York is home to some of the best researchers across the globe, and this funding will help ensure they can do the necessary work to grow our progress in stem cell science, New York Governor Andrew M. Cuomo said in announcing the awards on Jan. 12. This state is proud to be a leader in the health industry, and with this funding we will continue to develop modern, world-class research programs that work to make people worldwide healthier.

The concept behind this new and novel project, which builds on past Roswell Park research, is to unite the cancer-killing power of T cells with the long-term regenerative power of adult stem cells. By enlisting both killer CD8+ T cells and helper CD4+ T cells, the researchers will be able to turn a patients own, reprogrammed stem cells into immune cells armed with the ability to recognize and kill cancer cells.

This project represents a potentially paradigm-shifting approach in the use of immunotherapy to treat cancer, because we will be generating billions of these antitumor effector cells to continually control existing tumors and minimize the chance of relapse, said Dr. Odunsi, who is also Co-Leader of Roswell Parks Tumor Immunology and Immunotherapy Program and a Professor of Gynecology & Obstetrics at the University at Buffalo (UB). Reprograming adult hematopoietic stem cells for sustained attack against ovarian cancer is, to our knowledge, a completely new approach.

Like much previous RPCI research on immune therapies to combat ovarian cancer, this new project targets the NY-ESO-1 antigen, which is expressed in cancer cells but not in most normal body tissues. Because this protein is so widely expressed by various malignant tumors, the approach may have application in the treatment of other cancers as well.

The project will encompass both preclinical work and an early-phase clinical research study in patients with ovarian cancer, and will take advantage of three resources housed within the RPCI Center for Immunotherapy:

Roswell Park faculty members Thinle Chodon, MD, PhD, and Takemasa Tsuji, PhD, are also among Dr. Odunsis co-investigators, as are Dr. Richard Bankert, VMD, PhD, from the Department of Microbiology and Immunology at the University at Buffalo and Leonard Shultz, PhD, from The Jackson Laboratory, Bar Harbor, Maine.

This Roswell Park-developed, Roswell Park-led initiative is just the latest example of the ingenuity Dr. Odunsi and his team bring to the pressing challenge of how to develop better and more effective therapies for cancer, said Candace Johnson, PhD, President & CEO and Cancer Center Director at Roswell Park. We are enormously grateful for the leadership Gov. Cuomo and NYSTEM have shown in dedicating these funds strategically to address high-priority medical issues, and to the numerous individual and corporate donors whose contributions to the Roswell Park Alliance Foundation enabled the laboratory advances that Dr. Odunsi and his team will now be able to bring to patients.

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New Approach, New Hope: $12M New York State Investment Will Fast-Track Innovative Roswell Park Research in Ovarian ...

Global Stem Cells Group to Move Headquarters to Larger Miami Lakes Office Complex

MIAMI (PRWEB) January 14, 2015

Citing fast-paced growth and the need for more space to accommodate its expanding operations, Global Stem Cells Group CEO Benito Novas has announced plans to move the organizations headquarters from Sunrise, Florida to the Miami Lakes Corporate Center. The new location more than doubles the space for the international stem cell and regenerative medicine company's corporate offices.

Since opening in 2012 under the Regenestem brand, Global Stem Cells Group and its six operating companies have grown exponentially, establishing partnerships with stem cell clinics, hospitals, researchers and physicians in the Philippines, South America and Europe.

The new Global Stem Cells Group facility provides state-of-the-art space for our entire team to drive innovation through our research and development initiatives, and support partnering activities with our biotechnology products and education programs, Novas says. We now have the space to continue the fast-paced growth of our companies and advance the development of new stem cell and regenerative medicine technologies that will benefit patients worldwide.

The new corporate headquarters, scheduled to open January 15, 2015, are located in the Miami Lakes Corporate Center, 14750 NW 77th Court, Suite 304 Miami Lakes, FL 33016.

For more information visit the Global Stem Cells website, email bnovas(at)regenestem(dot)com, or call 305-224-1858.

About the Global Stem Cells Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions.

With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

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Global Stem Cells Group to Move Headquarters to Larger Miami Lakes Office Complex

Parkinson's stem cell trial approaches

A therapy for Parkinson's disease from Carlsbad's International Stem Cell Corp. is expected to get approval for testing in Australia as soon as February, the company said this week.

The publicly traded company has grown neural stem cells, which can mature into cells making the neurotransmitter dopamine, deficient in Parkinson's. The company plans to implant these stem cells into the the brains of Parkinson's patients, restoring dopamine production and normal movement in the patients.

If approved, the trial will be the first test of therapy with the company's cells, derived from unfertilized, or parthenogenetic human egg cells. The cells, which in theory can produce nearly all types of cells found in the body, are grown into neural stem cells. These cells will be implanted and mature in place.

Parthenogenetic cells have much the same potential as embryonic stem cells without the ethical objections some have, says International Stem Cell, which has 38 employees. In addition, these parthenogenetic stem cells are less likely to provoke an immune reaction, the company says.

International Stem Cell Corp. chose Australia for its first trial because its regulatory agency is more "interactive" than the U.S. Food and Drug Administration, said Simon Craw, executive vice president for business development. The FDA is inclined to give yes-or-no answers for proposed cell-based treatments, Craw said. In addition, patient recruitment takes place more slowly, which delays trial completion. The FDA does this for safety reasons.

Simon Craw / International Stem Cell Corp.

The Australian agency helps guide companies through the application process, Craw said in an interview Wednesday at Biotech Showcase, an annual life science conference in San Francisco. Craw also gave a company presentation on Tuesday at the conference.

"We're in the process of submitting the (application)," to Australian regulators, Craw said. "We're going back and forth with them right now. We expect to hear back from them by the end of February."

The trial will primarily assess safety, but also look for evidence of efficacy, Craw said.

The trial will take place at Royal Melbourne Hospital, Craw said. The hospital is headquartered in Parkville, in the state of Victoria. The principal investigator, Dr. Andrew Evans, will recruit patients from his own practice.

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Parkinson's stem cell trial approaches

City man who ran stem-cell trial for MS patients fabricated credentials, overstated results

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Winnipeg researcher Doug Broeska previously ran a lumber business. (REGENETEK.COM)

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Regenetek is located on Chevrier Boulevard, but its stem-cell study is being conducted at a hospital in India. The study is not listed on any clinical-trial registry. (PHIL HOSSACK / WINNIPEG FREE PRESS )

The hope of dancing at her sons summertime wedding led Sharon Nordstrom to pay $38,000 for a treatment she hoped would keep her multiple-sclerosis symptoms at bay.

That money paid for what she hoped would be a life-changing stem-cell procedure at a hospital in Pune, India. It was part of what she, and nearly 70 other patients from Manitoba and from as far away as Australia, believed was a clinical study helmed by a brilliant Winnipeg medical researcher with a PhD, who said the procedure could stop MS in its tracks.

Soon after her return in May, Nordstrom began to uncover troubling facts. Doug Broeska, whom patients reverently call "Dr. Doug," has no recognized medical credentials. Regenetek Research, his company based out of a spartan office on Chevrier Boulevard, boasted credentials and positive medical results that didnt add up. Patients who were once ardent supporters were attacked as saboteurs or shills for "Big Pharma" and threatened with removal from the study after they asked questions.

A Free Press investigation has found Broeska fabricated his credentials, including his PhD, and overstated the effects of the stem-cell treatment, for which he often charged desperately ill people $45,000. Four patients spoke to the Free Press on the record, saying they got no benefit from the treatment, got none of the followup common in clinical trials such as MRIs or physical acuity tests and believe they are victims of fraud.

Patients, doctors in India and now Canadian officials are questioning the claims of Winnipeg researcher Doug Broeska and his $45,000 stem-cell therapy for MS sufferers.

At least two of Regeneteks former patients have complained to the RCMP, and sources say the Canada Revenue Agency is investigating, though CRA officials would not confirm that. Last week, Regeneteks website, Broeskas LinkedIn page and a "patient-run" Facebook group were taken down.

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City man who ran stem-cell trial for MS patients fabricated credentials, overstated results

Lung Institute to Open New Clinic in Scottsdale in February 2015

Scottsdale, AZ (PRWEB) January 13, 2015

In February 2015, the Lung Institute will open a new clinic in Scottsdale, AZ. This expansion marks its third location in the country. With stem cell treatment centers already in Tampa and Nashville, the Lung Institute has made positive impacts in the lives of their patients and the surrounding communities.

The Lung Institute is committed to providing patients with an effective way to treat pulmonary conditions, rather than just manage their symptoms, which results in an improvement in their overall quality of life. Their application of innovative technology combined with advanced stem cell treatments enables them to carry out their mission and successfully provide world-class care to their patients who visit the Lung Institute from across the globe.

Medical Director, Dr. Burton Feinerman, a world-renowned physician and expert in the field of regenerative medicine, has led the Lung Institute in performing hundreds of minimally invasive, outpatient stem cell treatments for a variety of debilitating lung diseases. The Lung Institute treats conditions such as COPD, pulmonary fibrosis, chronic bronchitis, emphysema, and interstitial lung disease.

The addition of this treatment center will create jobs in the medical, sales, and administrative industries. Additionally, local businesses, and the medical tourism industry of the Scottsdale area will benefit, as most patients travel for treatment. By utilizing their full-service patient coordinator services, The Lung Institute plans to actively promote all that Scottsdale has to offer as an ancillary benefit to obtaining advanced treatment for lung disease.

A ribbon cutting ceremony will be held at the new facility with the medical staff, Lung Institute corporate team, community representatives, and members of the Scottsdale and Phoenix Chambers of Commerce in attendance. The new facility is located at 8377 East Hartford Drive in Scottsdale, and will be open for treatment beginning on February 9, 2015.

We are very excited to join the vibrant Scottsdale community and provide even greater access to convenient care for our patients, says Lynne Flaherty, Executive Vice President of the Lung Institute. Through stem cell therapy, we hope to offer patients an alternative method to treat their lung disease while enjoying an exceptional local environment.

About the Lung Institute At the Lung Institute, we are changing the lives of hundreds of people across the nation through the innovative technology of regenerative medicine. We are committed to providing patients a more effective way to address pulmonary conditions and improve quality of life. Our physicians, through their designated practices, have gained worldwide recognition for the successful application of revolutionary minimally invasive stem cell therapies. With over a century of combined medical experience, our doctors have established a patient experience designed with the highest concern for patient safety and quality of care. For more information, visit our website at LungInstitute.com, like us on Facebook, follow us on Twitter or call us today at (855) 313-1149.

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Lung Institute to Open New Clinic in Scottsdale in February 2015