MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Ischemic Stroke Clinical Trial

— MASTERS-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545607
• Other study ID #: B01-04
• Status: Recruiting
• Phase: Phase 3
• Start date: July 28, 2018
• Est. completion date: June 2023

Study information

• Verified date: February 2022
• Source: Athersys, Inc
• Contact: Athersys Clinical Trials Group
• Phone: (216) 426-3597
• Email: masters2[@]athersys.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Primary 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

Primary 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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Biological:
• MultiStem
single intravenous infusion 18-36 hours after stroke
• Placebo
single intravenous infusion 18-36 hours after stroke

Locations

Country	Name	City	State
Taiwan	Athersys Investigational Site 603	Taichung
Taiwan	Athersys Investigational Site 601	Taipei City
Taiwan	Athersys Investigational Site 602	Taoyuan City
United States	Athersys Investigational Site 109	Akron	Ohio
United States	Athersys Investigational Site 103	Augusta	Georgia
United States	Athersys Investigational Site 113	Boston	Massachusetts
United States	Athersys Investigational Site 115	Chattanooga	Tennessee
United States	Athersys Investigational Site 121	Chicago	Illinois
United States	Athersys Investigational Site 129	Clearwater	Florida
United States	Athersys Investigational Site 104	Cleveland	Ohio
United States	Athersys Investigational Site 118	Columbia	South Carolina
United States	Athersys Investigational Site 107	Hershey	Pennsylvania
United States	Athersys Investigational Site 101	Houston	Texas
United States	Athersys Investigational Site 105	Houston	Texas
United States	Athersys Investigational Site 111	Jackson	Mississippi
United States	Athersys Investigational Site 119	Kansas City	Kansas
United States	Athersys Investigational Site 108	Miami	Florida
United States	Athersys Investigational Site 125	Minneapolis	Minnesota
United States	Athersys Investigational Site 122	Palo Alto	California
United States	Athersys Investigational Site 128	Phoenix	Arizona
United States	Athersys Investigational Site 106	Pittsburgh	Pennsylvania
United States	Athersys Investigational Site 102	Portland	Oregon
United States	Athersys Investigational Site 127	Sacramento	California
United States	Athersys Investigational Site 110	Salt Lake City	Utah
United States	Athersys Investigational Site 130	Toledo	Ohio
United States	Athersys Investigational Site 124	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Athersys, Inc	Medpace, Inc.

Countries where clinical trial is conducted

United States,  Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis		90 days
Secondary	proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:	mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100]	365 days
Secondary	proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:	mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100]	90 days
Secondary	proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently		90 days