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

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

Recruiting

Start Date

2011-10-01

Completion Date

2014-11-01

Primary Completion Date

2013-10-01

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
proportion of subjects with a modified Rankin Scale (mRS) score of less than or equal to 2
90 days
No

Secondary Outcome

Measure

Time Frame

Safety Issue

change in functional outcome throughout range of mRS scores
90 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

140

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 79 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

79 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

Status

Investigator

Georgia Health Sciences University
Augusta Georgia 30912 United States
Recruiting
Last Name: David C Hess, MD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2011-10-01

Lastchanged Date

2011-10-21

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


Information obtained from ClinicalTrials.gov on January 22, 2013

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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