In keeping with its commitment to connect industry, regulatory experts, therapeutic societies and translational centers to advance emerging cellular therapies, ISCT announces its first commercial development focus group addressing Cell Therapies for Peripheral Vascular Disease (PVD).
PVD is a condition in which the arteries that carry blood to the arms or legs become narrowed or clogged. In a primary care population defined by age and common risk factors the prevalence of PVD is approximately one in three Critical Limb Ischemia (CLI) is a very severe condition of PVD with patients suffering severe pain and skin ulcers which can lead to limb amputation. CLI has a 15-30% mortality rate at 5 years.
To address this debilitating condition ISCT has created a progressive forum to unite an expert panel and facilitate in depth, open discussion of whether, and how, cell therapy can meet the unmet needs of these patients. The focus group will take place in New York, USA January 21 2011 in partnership with the Cardiovascular Research Foundation (www.crf.org), sponsor of the Sixth International Conference on Cell Therapy for Cardiovascular Disease.
"As we enter the era of 300+ patient Phase 3 studies, it is crucial for the research community to identify appropriate end points that correlate with meaningful clinical outcomes", said Warren Sherman, MD, Director, Regenerative Cardiovascular Research at The Jack H. Skirball Center for Cardiovascular Research. "From there, trial design can be optimized to assess clinical efficacy and, hopefully, improve outcomes of patients with CLI. These patients have a very poor prognosis. To help them with cell-based therapy would be a huge advance, and would have implications for patients with vascular disease of other organ systems,"
Ed Horwitz, M.D. PhD, President of ISCT strongly agreed, "the launch of this series of focus groups is the latest initiative through which ISCT is building alignment with academia and industry to expedite the development and maturation of the field and ultimately bring cell therapy treatments to patients faster. It is ISCT's intent that the international field of cell therapy and regenerative medicine will be able to benefit from the focus groups through public open access to the final report and outcomes as published in per reviewed journals".