Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

Study to Examine the Effects of MultiStem in Ischemic Stroke



Sponsors

Lead Sponsor


Collaborators



Source

Athersys, Inc

Oversight Info

Authority

United States: Food and Drug Administration

United Kingdom: Medicines and Healthcare Products Regulatory Agency


Has Dmc

Yes


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.

Overall Status

Completed

Start Date

2011-10-01

Completion Date

2015-12-01

Primary Completion Date

2015-03-01

Phase

Phase 2

Study Type

Interventional

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary Outcome

Measure

Time Frame

Safety Issue

frequency of dose limiting adverse events
7 days
Yes
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
90 days
No

Secondary Outcome

Measure

Time Frame

Safety Issue

proportion of subjects with a mRS score of less than or equal to 2
90 days
No
change in functional outcome throughout range of mRS scores
90 days
No
changes in outcome measures (mRS, NIHSS, BI) over time
365 days
No
proportion of subjects with an excellent functional outcome
90 days
No
frequency of adverse events
365 days
Yes
change in vital signs
365 days
Yes
change in safety labs
365 days
Yes
frequency of secondary infections
365 days
Yes

Enrollment

134

Condition


Intervention

Intervention Type

Biological

Intervention Name


Description

single infusion 1-2 days following ischemic stroke

Arm Group Label

Cohort 1

Cohort 2

Cohort 3



Intervention Type

Biological

Intervention Name


Description

single infusion 1-2 days following ischemic stroke

Arm Group Label

Cohort 1

Cohort 2

Cohort 3




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

Gender

Both

Minimum Age

18 Years

Maximum Age

83 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Robert W Mays, PhD
Study Director
Athersys, Inc

Overall Contact

Last Name

Medpace Inc

Phone

(866) 872-2349

Email

recruitment@medpace.com


Location

Facility

UCLA Medical Center
Los Angeles California 90095 United States
Stanford University
Stanford California 94305 United States
University of Miami
Miami Florida 33136 United States
Florida Hospital Orlando
Orlando Florida 32803 United States
Georgia Regents University
Augusta Georgia 30912 United States
Northwestern University
Chicago Illinois 60611 United States
University of Kentucky Medical Center
Lexington Kentucky 40536 United States
University of Louisville
Louisville Kentucky 40202 United States
Boston University
Boston Massachusetts 02118 United States
Henry Ford Health System
Detroit Michigan 48202 United States
University of Mississippi Medical Center
Jackson Mississippi 39216 United States
University of Nebraska Medical Center
Omaha Nebraska 68198-2045 United States
Summa Health System
Akron Ohio 44320 United States
University of Cincinnati
Cincinnati Ohio 45267 United States
Case Western Reserve University School of Medicine
Cleveland Ohio 44106 United States
MetroHealth Medical Center
Cleveland Ohio 44109 United States
Cleveland Clinic
Cleveland Ohio 44195 United States
Oregon Health Sciences University
Portland Oregon 97239 United States
The Pennsylvania State University
Hershey Pennsylvania 17033-0850 United States
Hospital for the University of Pennsylvania
Philadelphia Pennsylvania 19104 United States
University of Pittsburgh Medical Center Health System
Pittsburgh Pennsylvania 15213 United States
Palmetto Health Richland
Columbia South Carolina 29203 United States
Chattanooga Center for Neurologic Research
Chattanooga Tennessee 37403 United States
Methodist Hospital Research Institute
Houston Texas 77030 United States
The University of Texas Health Science Center
Houston Texas 77030 United States
University of Utah
Salt Lake City Utah 84132 United States
University of Glasgow - Western Infirmary
Glasgow G11 6NT United Kingdom
University of Glasgow - Southern General Hospital
Glasgow G12 8QQ United Kingdom
St. Georges Healthcare NHS Trust
London SW17 0QT United Kingdom
University College London Hospitals - Thames Stroke Research Network
London WC1E 6BT United Kingdom
The Newcastle upon Tyne Hospitals, NHS Foundation Trust
Newcastle upon Tyne NE7 7DN United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent ST4 6QG United Kingdom

Location Countries

Country

United Kingdom

United States



Verification Date

2016-07-01

Lastchanged Date

2016-07-29

Firstreceived Date

2011-09-15

Responsible Party

Responsible Party Type

Sponsor


Keywords


Is Fda Regulated

Yes

Has Expanded Access

No

Condition Browse


Number Of Arms

3

Is Section 801

Yes

Arm Group

Arm Group Label

Cohort 1

Arm Group Type

Experimental

Description

Low dose MultiStem or Placebo


Arm Group Label

Cohort 2

Arm Group Type

Experimental

Description

High dose MultiStem or Placebo


Arm Group Label

Cohort 3

Arm Group Type

Experimental

Description

Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

2016-07-29


ClinicalTrials.gov processed this data on September 13, 2016

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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