Abstract
Center for Stem Cell Research (a unit of inStem, Bengaluru), Department of Hematology, Christian Medical College, Vellore, India. Member at large of the ISCT Presidential Task Force on the Use of Unproven Cellular Therapies, Advanced Centre for Biochemical Engineering, University College London, London, United Kingdom. Member at large of the ISCT Presidential Task Force on the Use of Unproven Cellular Therapies, Voorburg, Netherlands. ISCT Europe, RegionalVice President 2014–2016, Andalusian Initiative for Advanced Therapies, Junta de Andalucia, Sevilla, Spain. Chair, ISCT EU LRA Committee, 2014–2016, Department of Medicine, University ofVermont, Burlington,Vermont, USA. ISCT Chief Scientific Officer 2014–2016. Chair, ISCT Pulmonary Committee 2013–2015, Division of Hematology/Oncology/BMT, Nationwide Children’s Hospital, Departments of Pediatrics and Medicine,The Ohio State University College of Medicine, Columbus, Ohio, USA. ISCT Past President 2010–2012, and Division of Oncology, Laboratory of Cellular Therapy, University of Modena & Reggio Emilia, Modena, Italy. ISCT President 2014–2016. Chair, ISCT Presidential Task Force on the Use of Unproven Cellular Therapies
Highlights
Given the potential of cell-based products, including stem/progenitor cells and immune cells, there is a global effort to introduce these therapies into the clinic to correct organ dysfunctions, to treat cancer and to abrogate autoimmune diseases and a wide variety of pathological conditions [1,2,3]
The ability to isolate, modify and stimulate immune cells prompted their use within adoptive immunotherapy to treat cancer [5]
There are fewer limitations related to intellectual property rights or cell-based technology methods than those customarily present during the development of small- and macro-molecule drugs. These freedoms promote robust, legitimate research and development, it has led to the parallel development of clinics worldwide that offer cellular therapies with questionable safety or efficacy data or unclear scientific rationale for the treatment of a variety of diseases. This has led to vulnerable patients subjecting themselves to unproven cellular therapies in an environment with inadequate regulatory oversight or reliable information about potential risks or benefits [6,7]
Summary
Given the potential of cell-based products, including stem/progenitor cells and immune cells, there is a global effort to introduce these therapies into the clinic to correct organ dysfunctions, to treat cancer and to abrogate autoimmune diseases and a wide variety of pathological conditions [1,2,3]. Easy access to these cells, obtained from marrow, adipose, cord blood and other human tissues, provides tremendous opportunity for translational research, for indications with no satisfactory medical solution for patients with “unmet medical needs.” Prenatal and adult stem cells
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