Upstream and Downstream Bioprocessing of UCB-HSCs (v0.1)
Research type
Research Study
Full title
Development of a Scalable and Robust Manufacturing Process for the Production of Clinically-Relevant Umbilical Cord Blood-Derived Haematopoietic Stem Cells
IRAS ID
233003
Contact name
Qasim Rafiq
Contact email
Sponsor organisation
Biovault Technical Ltd
Duration of Study in the UK
2 years, 8 months, 18 days
Research summary
This project aims to elucidate optimal isolation and expansion techniques to assist future large-scale manufacture of umbilical cord blood (UCB) derived haematopoietic stem cells (HSC). UCB comprises a rich source of HSCs, and is associated with fewer challenges than other sources in which they may be found.
Bone marrow, for example, has frequently been used as a HSC source, and is extracted in a notoriously painful process. In contrast, UCB is often regarded as waste post-birth and its procurement is not deleterious to mother or child.HSCs are already used globally in the clinic for the treatment of malignant and non-malignant conditions involving the blood, such as leukaemia. They are also being investigated as a potential cell therapy for other 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 UCB, minimising microbiological contamination and effective, scalable 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 HSC for research, although donated UCB will not be used directly in any therapies/products.This study was formulated as a collaborative industry placed PhD project between Biovault Technical Ltd and Unviersity College London, and will involve research at both commercial and university laboratories. Participants will be recruited from a NHS hospital and overseas partners, providing informed consent is achieved.
UCB will be delivered by donor mothers according to standard clinical practice, and collected following delivery by a health professional. Following procurement, no further contact with study participants will be necessary to complete the research.
REC name
HSC REC A
REC reference
18/NI/0056
Date of REC Opinion
16 Apr 2018
REC opinion
Further Information Favourable Opinion