Bringing Advanced Therapy Medicinal Products (ATMPs) for Parkinson's Disease to the Clinic: The Investigator's Perspective.
Accepted version
Peer-reviewed
Repository URI
Repository DOI
Change log
Authors
Barker, Roger A
Cutting, Emma V
Daft, Danielle M
Abstract
There is much excitement around the use of advanced therapy medicinal products (ATMPs), including cell and gene treatments, in Parkinson's disease (PD). However, taking an ATMP to clinical trials in patients with PD is complex. As such it is important from an investigator's perspective that they ask themselves two key questions before embarking on such work: firstly, why are you doing it, and, secondly, do you understand what is needed to conduct a clinical trial with that product. In this article, we briefly discuss these two questions.
Description
Keywords
ATMP, Parkinson’s disease, clinical trial, gene therapy, regulations, stem cells, Humans, Parkinson Disease
Journal Title
J Parkinsons Dis
Conference Name
Journal ISSN
1877-7171
1877-718X
1877-718X
Volume Title
11
Publisher
SAGE Publications
Publisher DOI
Rights
All rights reserved
Sponsorship
Wellcome Trust (203151/Z/16/Z)
National Institute for Health and Care Research (IS-BRC-1215-20014)
Medical Research Council (MC_PC_17230)
Medical Research Council (MR/R015724/1)
National Institute for Health and Care Research (IS-BRC-1215-20014)
Medical Research Council (MC_PC_17230)
Medical Research Council (MR/R015724/1)