Risk and regulationIn the development of cell therapy products, there are three main phases that drive the choices (and costs) involved in manufacturing: research, clinical trial and licensed (approved to sell for clinical use). Part one of this two-part series looked primarily at the key drivers in the research phase. This provides an overview of considerations for clinical trials and the production of a licensed product.Image: Lisa WillemseLet’s assume you’ve run the gauntlet of pre-clinical research and…

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A stem cell therapy to reboot the immune system may give organ transplant recipients longer and better outcomes.Dr. Gary Levy is undertaking an innovative new trial aimed at improving the outcomes of organ transplantation. Photo: University Health Network.Donated organs provide new hope and extended life for the more than 2,500 Canadians who receive a transplant each year. But for many of these patients, the new organs also come with a catch: they have expiration dates.The main…

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Image: Lisa WillemseMore cell therapies are entering clinical trials with big hopes for approval in the near future. But the manufacturing of these cells is — and perhaps always will be — a boutique enterprise, with many factors requiring careful consideration. This first article in a two-part series looks at starting small, defining processes and scalability.If your only exposure to cell manufacturing until now has been the meagre information offered up on the websites of unregulated stem cell clinics, you…

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In 2001, Dr. Harold Atkins, an OIRM scientist, enrolled the first patients in a clinical trial for an aggressive, untested treatment for multiple sclerosis. A short time later, patient number five failed — by recovering far beyond what anyone had imagined. Now, Dr. Atkins is being recognized for his pioneering efforts with the Till & McCulloch Award.Dr. Harold Atkins, the recipient of the 2017 Till & McCulloch Award.As clinical trials go, early phases are not about cures,…

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Stock imageStem cell researcher Dr. William Stanford knows broken bones. He’s especially familiar with osteoporosis, a disease characterized by bone fragility. In his Ottawa home, Stanford works until the wee hours writing papers and grants that keep his research moving forward. His motivation is simple: finding a cure for osteoporosis.“I have gotten letters from patients who have the most debilitating forms of the disease one can imagine. They’ll list off all the fractures they get…

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A muscle stem cell is shown with a pink centre and green outline, sitting on the edge of a muscle fibre. (Image courtesy of Dr. Michael Rudnicki)Our knowledge of human anatomy hasn’t changed much in a hundred years. What has changed is our understanding about how our bodies build that anatomy and maintain it throughout life. As our tissues and organs develop and heal, every gene that gets activated, every protein that signals a cell…

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Tissue culture platforms could help researchers better understand and treat Duchenne muscular dystrophyThese human pluripotent stem cell-derived motor neuron clusters are immunostained so that the motor neuron cell bodies are red and the motor neurons neurites are green. (Image courtesy Penney Gilbert lab)Penney Gilbert is harnessing new technology to revisit old questions about muscular dystrophy.Gilbert, an assistant professor at the University of Toronto’s Institute for Biomaterials & Biomedical Engineering, has engineered a three-dimensional tissue culture platform…

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Dr. Bernard Thébaud’s research using stem cells as a therapy for chronic lung disease in premature infants is advancing thanks to a new grant from the Ontario Institute for Regenerative Medicine.Dr. Bernard Thébaud. Photo: The Ottawa HospitalExtremely premature babies enter the world with more health challenges than most of us will see in our entire lifetime. Strikingly long, the list of complications includes heart, vision, hearing, gastrointestinal, developmental and respiratory problems, many of which persist throughout…

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From the lab to the clinic to the local newspaper, managing expectations around stem cell therapies is everyone’s job.The landmark autologous hematopoietic stem-cell transplantation for aggressive MS trial team from The Ottawa Hospital Research Institute. Left to right: Dr. Mark Freedman, Dr. Harold Atkins, trial participant Jennifer Molson and MS clinic manager Marjorie Bowman.Traversing the so-called Valley of Death in stem cell research — where potential therapies die before they can be translated into clinical practice — is often considered…

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