GMP Validation - Lipoaspiration
Research type
Research Study
Full title
Lipoaspirate procurement from Volunteers - Cambridge to Galway for good manufacture practice (GMP) validation
IRAS ID
200226
Contact name
Andrew McCaskie
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
The aim of this study is to validate processes surrounding the procurement of adipose (fat) tissue in Cambridge from the waste product of patients undergoing lipoaspiration.
This lipoaspirate will be used for the validation of the transport and production processes of Adipose derived stem cells between Cambridge UK and the production centre in Galway Ireland.
The Cell product will be produced in Galway at The Centre for Cell Manufacturing Ireland (CCMI) National University of Ireland Galway. The cell product from this feasibility study will be returned to Cambridge but will not be used on patient and will be destroyed.
This is in preparation for the ADIPOA2 (www.adipoa2.eu) Trial due start in 2016.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0257
Date of REC Opinion
5 Aug 2016
REC opinion
Further Information Favourable Opinion