Clinical trial NCT03545607: MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
Official title: MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: ischemic stroke
adult stem cells
Lead sponsor: Healios K.K.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2018-06-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
timeFrame: 90 days
Secondary outcomes:
measure: proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
timeFrame: 365 days
measure: proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
timeFrame: 90 days
measure: 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
timeFrame: 90 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Athersys Investigational Site 128
state: Arizona
city: Palo Alto
country: United States
facility: Athersys Investigational Site 122
state: California
city: Sacramento
country: United States
facility: Athersys Investigational Site 127
state: California
city: Clearwater
country: United States
facility: Athersys Investigational Site 129
state: Florida
city: Miami
country: United States
facility: Athersys Investigational Site 108
state: Florida
city: Augusta
country: United States
facility: Athersys Investigational Site 103
state: Georgia
city: Chicago
country: United States
facility: Athersys Investigational Site 121
state: Illinois
city: Kansas City
country: United States
facility: Athersys Investigational Site 119
state: Kansas
city: Wichita
country: United States
facility: Athersys Investigational Site 124
state: Kansas
city: Boston
country: United States
facility: Athersys Investigational Site 113
state: Massachusetts
city: Minneapolis
country: United States
facility: Athersys Investigational Site 125
state: Minnesota
city: Jackson
country: United States
facility: Athersys Investigational Site 111
state: Mississippi
city: Akron
country: United States
facility: Athersys Investigational Site 109
state: Ohio
city: Cleveland
country: United States
facility: Athersys Investigational Site 104
state: Ohio
city: Toledo
country: United States
facility: Athersys Investigational Site 130
state: Ohio
city: Portland
country: United States
facility: Athersys Investigational Site 102
state: Oregon
city: Hershey
country: United States
facility: Athersys Investigational Site 107
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Athersys Investigational Site 106
state: Pennsylvania
city: Columbia
country: United States
facility: Athersys Investigational Site 118
state: South Carolina
city: Chattanooga
country: United States
facility: Athersys Investigational Site 115
state: Tennessee
city: Houston
country: United States
facility: Athersys Investigational Site 101
state: Texas
city: Houston
country: United States
facility: Athersys Investigational Site 105
state: Texas
city: Salt Lake City
country: United States
facility: Athersys Investigational Site 110
state: Utah
city: Taichung
country: Taiwan
facility: Athersys Investigational Site 603
city: Taipei City
country: Taiwan
facility: Athersys Investigational Site 601
city: Taoyuan City
country: Taiwan
facility: Athersys Investigational Site 602
Study officials:
affiliation: Healios K.K.
name: Robert W Mays, PhD
role: STUDY_DIRECTOR
References:
citation: 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.