Bioprocessing of UCT-MSC
Research type
Research Study
Full title
Bioprocessing of umbilical cord tissue derived mesenchymal stem cells for cell therapy applications
IRAS ID
211676
Contact name
Qasim Rafiq
Contact email
Sponsor organisation
Biovault Technical Ltd
Duration of Study in the UK
1 years, 9 months, 17 days
Research summary
This project aims to elucidate optimal isolation and expansion techniques to assist future large-scale manufacture of umbilical cord tissue derived mesenchymal stem cells (MSC). Umbilical cord tissue comprises a rich source of mesenchymal stem cells, and is associated with fewer challenges than other tissues in which they may be found. Bone marrow, for example, has frequently been used as an MSC source, and is extracted in a notoriously painful process. In contrast, umbilical cord tissue is often regarded as waste post-birth and its procurement is not deleterious to mother or child.
Mesenchymal stem cells have been extensively investigated for applications in cell therapies for a wide range of diseases, but robust, standardised manufacture methods to produce sufficient quantities of cells of clinical-grade quality are required to develop products to meet future demands. Strategies for optimal cell isolation from umbilical cord tissue, minimising microbiological contamination and effective, scalable microcarrier-bioreactor cell processing must be developed in order to harness the potential of cell therapy research. To meet these objectives, the study is expected to last up to three years. Benefits to the public include the advancement of cell therapy development and increased knowledge of a less ethically controversial source of MSC for research, although donated tissue will not be used directly in any therapies/products.
This study was formulated as a collaborative knowledge transfer partnership (KTP) between Biovault Technical Ltd and Aston University, and will involve research at both commercial and university laboratories. Participants will be recruited from a local NHS hospital and overseas partners and provide informed consent.
Umbilical cord tissue will be delivered by donor mothers according to standard clinical practice, and the umbilical cord tissue collected following delivery by a health professional. Following tissue procurement, no further contact with study participants will be necessary to complete the research.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0185
Date of REC Opinion
7 Jun 2017
REC opinion
Favourable Opinion