Clinical trial NCT01436487: Study to Examine the Effects of MultiStem in Ischemic Stroke
Official title: Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: ischemic stroke
adult stem cells
Lead sponsor: Healios K.K.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2011-09-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18 and 83 years of age (inclusive)
* Clinical diagnosis of cortical cerebral ischemic stroke
* Occurrence of a moderate to moderately severe stroke

Exclusion Criteria:

* Presence of a lacunar or a brainstem infarct
* Reduced level of consciousness
* Major neurological event such as stroke or clinically significant head trauma within 6 months of study

Primary outcomes:
measure: frequency of dose limiting adverse events
timeFrame: 7 days
measure: Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
timeFrame: 90 days
Secondary outcomes:
measure: proportion of subjects with a mRS score of less than or equal to 2
timeFrame: 90 days
measure: change in functional outcome throughout range of mRS scores
timeFrame: 90 days
measure: changes in outcome measures (mRS, NIHSS, BI) over time
timeFrame: 365 days
measure: proportion of subjects with an excellent functional outcome
timeFrame: 90 days
measure: frequency of adverse events
timeFrame: 365 days
measure: change in vital signs
timeFrame: 365 days
measure: change in safety labs
timeFrame: 365 days
measure: frequency of secondary infections
timeFrame: 365 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University School of Medicine
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Hershey
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital for the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Center for Neurologic Research
state: Tennessee
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Glasgow
country: United Kingdom
facility: University of Glasgow - Western Infirmary
city: Glasgow
country: United Kingdom
facility: University of Glasgow - Southern General Hospital
city: London
country: United Kingdom
facility: St. Georges Healthcare NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals - Thames Stroke Research Network
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Staffordshire
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.