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Bringing Advanced Therapy Medicinal Products (ATMPs) for Parkinson's Disease to the Clinic: The Investigator's Perspective.

Accepted version
Peer-reviewed

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Type

Article

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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

Volume Title

11

Publisher

IOS Press

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)