Study to Examine the Effects of MultiStem in Ischemic Stroke

Summary

A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.

Timeline

Start

2011-10

Primary completion

2015-03

Completion

2015-12

Outcome

Missed primary endpoint

paper There was no difference between the multipotent adult progenitor cell group and placebo groups in global stroke recovery at day 90 PMID 28320635 ↗

paper Although no significant improvement was observed at 90 days in neurological outcomes with multipotent adult progenitor cells treatment PMID 28320635 ↗

Publications

• Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, Yavagal DR, Uchino K, Liebeskind DS, Auchus AP, Sen S, Sila CA, Vest JD, Mays RW. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 May;16(5):360-368. doi: 10.1016/S1474-4422(17)30046-7. Epub 2017 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MultiStem	Cell therapy	400 cells	Intravenous
Subject	MultiStem	Cell therapy	1200 cells	Intravenous

Indications