Collection of clinical remnant material from TPEX (version 1)
Research type
Research Study
Full title
Collection of clinical remnant material from patients with various conditions, who are undergoing treatment by Therapeutic Plasma Exchange (TPEX). Material will be used as a raw material for the manufacture of native human proteins, to provide Disease State plasma for the development of new diagnostic test kits and may also be used for other appropriate applications.
IRAS ID
167526
Contact name
Simon Packer
Contact email
Sponsor organisation
BBI Solutions
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Therapeutic plasma exchange (TPEX) involves extra-corporeal processing of a patient's blood to remove large-molecular-weight substances from the plasma. Such substances are pathogenic autoantibodies (e.g. Myasthenia Gravis: autoantibody to acetyl cholinesterase receptor), cryoglobulins or other abnormal plasma proteins (e.g. Waldenstrom's macroglobulinaemia: monoclonal immunoglobulin) or immune complexes (e.g. Goodpasture's syndrome: autoantibody to basement membrane). Several treatments are usually given. Typically 30−40 ml/kg of plasma (1−1.5 plasma volumes) are removed and replaced with albumin or albumin and normal saline during each procedure. The procedure must be controlled to ensure that the patient is kept in fluid balance, maintaining a stable, normal plasma volume. A single exchange removes approximately 75% of the patient's own plasma and the abnormal constituent in the plasma. A series of three consecutive daily plasma exchanges will remove about 95% of a circulating IgG antibody.
Patients with certain conditions are required to undergo Therapeutic Plasma Exchange (TPEX) as part of their treatment. These patients present with elevated levels of various biomarkers in their plasma. Clinical remnant plasma generated during TPEX will be collected following treatment by clinical staff on the relevant ward. The plasma will be stored and then transported to BBI Solutions. BBI Solutions will use the plasma as a raw material for the manufacture of native human proteins, as well as supplying it to various companies conducting development work on new diagnostic test kits. The material is important to ensure that the new kits are able to detect the required biomarker.
BBI Solutions will supply storage facilities for the collected plasma at the clinical site. There will be some testing which the company will perform on the supplied plasma, the results of which will be used as part of the project.REC name
Wales REC 6
REC reference
15/WA/0222
Date of REC Opinion
11 Jun 2015
REC opinion
Favourable Opinion