MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

Phase 1

• Conditions: Acute ischemic stroke; MedDRA version: 22.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001680-69-DE
• Lead Sponsor: Athersys, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-28
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Male or female subjects =18 years of age
•Clinical diagnosis of ischemic stroke involving cerebral cortex
•Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by =4 points during the initial screening period
•A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion Criteria

•Presence of a lacunar or a brainstem infarct
•Comatose state
•Brain hemorrhage
•Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified