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44 cell and gene therapy products approved in the world
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44 cell and gene therapy products approved in the world

The International Society for Cell and Gene Therapy (ISCT), the global professional society of clinicians, researchers, regulatory specialists, technologists and industry partners in the cell and gene therapy sector, has published its first annual report detailing global cell and gene therapies (CGT) with market authorization. This report is intended to provide a centralized resource and increased clarity for all of those involved in the CGT industry (scientific community, healthcare stakeholders, patient associations). It has been designed to react to the increase in momentum around a widening number of CGT authorizations, as well as a parallel increase of unproven approaches where cells are delivered as treatments without rigorous scientific and regulatory assessment and authorization.

The report provides an annual breakdown of CGTs that have received, as well in some cases, have withdrawn, market approval. 44 unique products were identified. 84% were cell and tissue therapies, and 55% were autologous. More than one third target oncological or hematologic conditions. In the US, there are over 16 cell, tissue and gene products with marketing authorization, 14 in Korea, eight in Europe, four in India and Japan, two in Canada, and one each in China and Australia. This contrasts with Russia, Middle East, Africa, Central and South America, which have no CGT market authorizations or data available.
This report also lists cell/tissue/gene products with the RMAT (regenerative medicine advanced therapy) designation in the US. 21 products were recognized as such. This includes six gene therapy products (four AAV-based products, one lentiviral and one retroviral product), 12 cell therapy products and three tissue engineered products now in development.

This reliable, up-to-date resource will help patients to make informed decisions before receiving a CGT treatment so that they can avoid being exposed to unproven and unlicensed cell interventions not approved by a regulatory or medicine agency. The report will be a regularly updated document that will be republished yearly, and accessible through the ISCT website.
The report has been prepared by select members of the ISCT Presidential Task Force (PTF) on the Use of Unproven and/or Unethical Cell & Gene Therapies (UCGT) with lead authors Natividad Cuende (Executive Director, Andalusian Initiative for Advanced Therapies, Seville, Spain) and Laertis Ikonomou (Assistant Professor of Medicine, Boston University School of Medicine, Boston, MA). The ISCT Presidential Task Force was formed in 2014 to support ISCT’s ongoing commitment to address the rise of commercially available unproven or insufficiently proven CGT treatments. These approaches are targeted at hopeful individuals seeking cures or health improvement for a variety of conditions. The PTF-UCGT characterizes unproven cellular interventions and promotes safe and effective practices worldwide.


 


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