Clinical trial design for stem cell therapies in stroke: What have we learned?

Muir, K. W. (2017) Clinical trial design for stem cell therapies in stroke: What have we learned? Neurochemistry International, 106, pp. 108-113. (doi:10.1016/j.neuint.2016.09.011) (PMID:27623094)

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Abstract

Stem cells of various sources have been investigated in a series of small, safety and feasibility-focused studies over the past 15 years. Understanding of mechanisms of action has evolved and the trial paradigms have become focused on two different approaches – one being an early subacute delivery of cells to reduce acute tissue injury and modify the tissue environment in a direction favourable to reparative processes (for example by being anti-inflammatory, anti-apoptotic, and encouraging endogenous stem cell mobilisation); the other exploring later delivery of cells during the recovery phase after stroke to modulate the local environment in favour of angiogenesis and neurogenesis. The former approach has generally investigated intravenous or intra-arterial delivery of cells with an expected paracrine mode of action and no expected engraftment within the brain. The latter has explored direct intracerebral implantation adjacent to the infarct. Several relevant trials have been conducted, including two controlled trials of intravenously delivered bone marrow-derived cells in the early subacute stage, and two small single-arm phase 1 trials of intracerebrally implanted cells. The findings of these studies and their implications for future trial design are considered.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Muir, Professor Keith
Authors: Muir, K. W.
College/School:College of Medical Veterinary and Life Sciences > Institute of Neuroscience and Psychology
Journal Name:Neurochemistry International
Publisher:Elsevier
ISSN:0197-0186
ISSN (Online):1872-9754
Published Online:10 September 2016
Copyright Holders:Copyright © 2016 Elsevier Ltd.
First Published:First published in Neurochemistry International 106:108-113
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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