Center for Commercialization of Regenerative Medicine

Toronto, Canada

Center for Commercialization of Regenerative Medicine

Toronto, Canada
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Prowse A.B.J.,Center for Commercialization of Regenerative Medicine | Timmins N.E.,Center for Commercialization of Regenerative Medicine | Yau T.M.,University of Toronto | Yau T.M.,Toronto General Research Institute | And 8 more authors.
Canadian Journal of Cardiology | Year: 2014

Despite advances in coronary artery disease treatment and prevention, myocardial damage due to acute myocardial infarction (MI) remains a major cause of morbidity and mortality in the population. Cell-based clinical trials to treat MI have focused on cells derived from the bone marrow or those potentially possessing functional similarities such as skeletal myoblasts or cardiac progenitors isolated from heart biopsies. Any benefits provided by these cells in improving heart function, left ventricular ejection fraction, or extending life expectancy after MI have been credited mostly to paracrine effects. Functional restoration of damaged myocardium will require a functional cell type with similar phenotype and characteristics of the damaged tissue that can also integrate, survive, and electrically couple to the host. Human pluripotent stem cells (hPSCs) have the ability to differentiate into multiple cell types of the adult body. hPSC-derived cardiomyocytes represent a promising target population for cell-based therapies for MI because they are scalable and the product can be defined with a specific set of release criteria. The purpose of this article is to review the rationale for cell therapy in heart disease, discuss the properties of hPSC cardiomyocytes that define their usefulness for regenerative therapy, consider manufacturing issues and preclinical investigation, and finally examine the steps required to establish effective clinical implementation. Pluripotent stem cell-derived cardiomyocyte-based therapies have enormous potential to revolutionize the management of heart disease; expedient but careful development is needed to ensure that this potential is fully realized. © 2014 Canadian Cardiovascular Society.

Brindley D.A.,University College London | Brindley D.A.,Harvard Stem Cell Institute | Brindley D.A.,Harvard University | Davie N.L.,University College London | And 7 more authors.
Cell Stem Cell | Year: 2012

In the first quarter of 2012, publicly traded companies in the cell-based therapy industry continued to show promising overall growth. Highlights included $85 million in new capital investment and steady clinical trial progress. © 2012 Elsevier Inc.

Mason C.,University College London | McCall M.J.,Loughborough University | Suthasan S.,University College London | Edwards-Parton S.,University College London | And 3 more authors.
Cell Stem Cell | Year: 2012

During Q2-Q3 2012, the cell therapy industry benefited from a number of positive external influences including advantageous changes to future FDA regulation, but stock market activity was highly mixed. The FDA approved two more products and an appreciable number of public-company-sponsored clinical trials are progressing through phases 1-3. © 2012 Elsevier Inc.

Mason C.,University College London | Mason J.,Kingston University | Bonfiglio G.A.,Partners at Venture | Bonfiglio G.A.,Center for Commercialization of Regenerative Medicine | Reeve B.C.,Harvard Stem Cell Institute
Cell Stem Cell | Year: 2013

During Q4 2012 and Q1 2013, the cell therapy industry made strong progress in translation and commercialization. Continued development of the companies included in a dedicated stock market index suggests emergence of this industry as a distinct healthcare sector. © 2013 Elsevier Inc.

Lipsitz Y.Y.,University of Toronto | Timmins N.E.,Center for Commercialization of Regenerative Medicine | Zandstra P.W.,University of Toronto | Zandstra P.W.,Center for Commercialization of Regenerative Medicine
Nature Biotechnology | Year: 2016

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

Johnson S.,Center for Commercialization of Regenerative Medicine
Stem Cells and Development | Year: 2013

If everyone is moving forward together, then success takes care of itself. This quote by Henry Ford, the American industrialist who founded the Ford Motor Company, nicely captures the ethos of the regenerative medicine (RM) community in Canada. Or, put another way, hockey is Canada's sport [and] stem cells are Canada's science [1].

Chen X.,University of Queensland | Prowse A.B.J.,University of Queensland | Prowse A.B.J.,Amgen Inc. | Jia Z.,University of Queensland | And 5 more authors.
Biomacromolecules | Year: 2014

The development of robust suspension cultures of human embryonic stem cells (hESCs) without the use of cell membrane disrupting enzymes or inhibitors is critical for future clinical applications in regenerative medicine. We have achieved this by using long, flexible, and thermoresponsive polymer worms decorated with a recombinant vitronectin subdomain that bridge hESCs, aiding in hESC's natural ability to form embryoid bodies (EBs) and satisfying their inherent requirement for cell-cell and cell-extracellular matrix contact. When the EBs reached an optimal upper size where cytokine and nutrient penetration becomes limiting, these long and flexible polymer worms facilitated EB breakdown via a temperature shift from 37 to 25 C. The thermoresponsive nature of the worms enabled a cyclical dissociation and propagation of the cells. Repeating the process for three cycles (over eighteen days) provided a >30-fold expansion in cell number while maintaining pluripotency, thereby providing a simple, nondestructive process for the 3D expansion of hESC. © 2014 American Chemical Society.

Bauwens C.L.,Center for Commercialization of Regenerative Medicine | Ungrin M.D.,University of Calgary
Methods in Molecular Biology | Year: 2014

The formation of cells into more physiologically relevant three-dimensional multicellular aggregates is an important technique for the differentiation and manipulation of stem cells and their progeny. As industrial and clinical applications for these cells increase, it will be necessary to execute this procedure in a readily scalable format. We present here a method employing microwells to generate large numbers of human pluripotent stem cell aggregates and control their subsequent differentiation towards a cardiac fate. © 2014 Springer Science+Business Media New York.

Ogbogu U.,University of Alberta | Johnson S.,Center for Commercialization of Regenerative Medicine
Regenerative Medicine | Year: 2012

If Canadians have a global reputation for being 'nice', then our propensity for scientists to collaborate should come as no surprise. The Canadian stem cell and regenerative medicine field is particularly strong in terms of collaboration, research results and innovative programs to leverage investments in the sector. Canada continues to see significant achievements and changes that will have a broad impact on the ability to move translational research forward in the near future. © 2012 Future Medicine Ltd.

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