| Literature DB >> 27720637 |
Nazem Atassi1, Ettore Beghi2, Miguel Blanquer3, Nicholas M Boulis4, Roberto Cantello5, Claudia Caponnetto6, Adriano Chiò7, Stephen B Dunnett8, Eva L Feldman9, Angelo Vescovi10, Letizia Mazzini11.
Abstract
Intraspinal stem cell (SC) transplantation represents a new therapeutic approach for amyotrophic lateral sclerosis (ALS) clinical trials. There are considerable difficulties in designing future efficacy trials, some related to the field of ALS and some that are specific to SCs or the mode of delivery. In October 2015, the most controversial points on SC transplantation were addressed during an international workshop intended to bring together international SC and ALS researchers in a public discussion on a topic for which expertise is limited. During the meeting, a discussion was started on the basic structure of the ideal clinical trial testing the efficacy and safety of SC transplantation. The current document includes a number of consensus points reflecting the design of phase II/III clinical trials.Entities:
Keywords: ALS; clinical trials; stem cells; transplantation
Mesh:
Year: 2016 PMID: 27720637 DOI: 10.1016/j.jcyt.2016.08.005
Source DB: PubMed Journal: Cytotherapy ISSN: 1465-3249 Impact factor: 5.414