Tissue engineering with autologous stem cells

Added: 12th August 2015

Working with a client from initial spin-out from a UK university, we guided development to gain first-in-man clinical trial approval for a novel tissue engineering product based on autologous bone-marrow derived mesenchymal stem cells and a medical device. This product presented many challenges associated with autologous advanced therapies, including a very short shelf life requiring great care in scheduling of patient biopsies, product manufacture and delivery for implantation.

A common issue with autologous products is the scarcity of starting material for product characterisation and process validation. We provided a thorough understanding of the regulatory requirements which allowed the team to optimise the development based on available bone marrow. We led the team through a Scientific Advice process, and maintained close contact with the national Competent Authority so that we were able to define a suitable strategy to meet the regulators' expectations with respect to validation, testing and characterisation. The CTA was approved without any questions on this challenging aspect of development.

"CellData Services has worked with us since 2007 on the development of our stem cell technology for meniscus repair. Alison has played a vitally important role in identifying and managing regulatory issues and developed the regulatory strategy that led to successful progression to our first-in-man clinical trial. She combines an abundance of expert regulatory knowledge with hands-on practical experience of working within the pharmaceutical industry to help optimise progression of the development programme. Throughout our time working together CellData has been pro-active in supporting our ongoing development programme with clear and detailed input, providing understandable and relevant regulatory guidance at each step. Alison is a delight to work with and we are very happy to continue with her providing expert support for our project."

- Chief Scientific Officer - Azellon Ltd, UK

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