Generation of a GMP-Grade Bank of MSCs for Clinical Use
Research type
Research Study
Full title
Use of surplus umbilical cord tissue for the derivation of mesenchymal stromal cells (MSCs) at GMP grade, for storage with the aim of future clinical use and to support research on MSCs.
IRAS ID
273305
Contact name
Joanne Mountford
Contact email
Sponsor organisation
Scottish National Blood Transfusion Service
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Mesenchymal stromal cells (MSC) have been demonstrated in the literature to have beneficial effects in controlling immune responses and providing trophic support as well as the ability to become several different cell types. SNBTS wish to harness these properties to generate a cellular therapeutic for a number of potential clinical uses. For example transplantation of the MSCs alongside pancreatic islets in the treatment of Type 1 Diabetes, and/or to promote healing of complex bone fractures. To this end, we previously undertook successful studies into the isolation and expansion of MSC from Wharton’s jelly (IRAS study: 139572) and development of clinically acceptable methods for deriving, expanding and banking these cells (IRAS study: 252920).
SNBTS now wish to obtain ethical permission to use umbilical cord tissue as a source material to generate a GMP-grade bank of cryopreserved MSCs suitable for a variety of uses. Under this ethics application the cells would be made available for the following uses:
- For use in quality control assays to ensure the quality and safety of the cells, including characterisation and functional testing.
- For ongoing stability testing of the product using the quality control assays mentioned above. This testing must be carried out at regular intervals and the authors wish to continue to carry out this testing outwith the study period for the lifetime of the cell bank.
- For use in pre-clinical studies prior to administration to humans. These pre-clinical studies may include administration to animals.In the future SNBTS wish to make the GMP-grade MSCs available for direct clinical use or further manufacture by SNBTS or third parties (including commercial). Further manufacture and/or clinical use of the cells will require separate ethical consideration under distinct REC applications.
REC name
HSC REC A
REC reference
20/NI/0027
Date of REC Opinion
10 Mar 2020
REC opinion
Further Information Favourable Opinion