Study to Examine the Effects of MultiStem in Ischemic Stroke - Full Text View

Sponsor:	Athersys, Inc
Collaborator:	Medpace, Inc.
Information provided by (Responsible Party):	Athersys, Inc
ClinicalTrials.gov Identifier:	NCT01436487

Purpose

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.

Condition	Intervention	Phase
Ischemic Stroke	Biological: MultiStem Biological: Placebo	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
Official Title:	Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

Further study details as provided by Athersys, Inc:

Primary Outcome Measures:

frequency of dose limiting adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
proportion of subjects with a modified Rankin Scale (mRS) score of less than or equal to 2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in functional outcome throughout range of mRS scores [ Time Frame: 90 days ] [ Designated as safety issue: No ]
proportion of subjects with an excellent functional outcome [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- mRS score = 0 to 1; and
- NIHSS score = 0 to 1; and
- Barthel Index score = greater than or equal to 95
frequency of adverse events [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
change in vital signs [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
change in safety labs [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
frequency of secondary infections [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	October 2011
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 Low dose MultiStem or Placebo	Biological: MultiStem single infusion 1-2 days following ischemic stroke Biological: Placebo single infusion 1-2 days following ischemic stroke
Experimental: Cohort 2 High dose MultiStem or Placebo	Biological: MultiStem single infusion 1-2 days following ischemic stroke Biological: Placebo single infusion 1-2 days following ischemic stroke
Experimental: Cohort 3 Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo	Biological: MultiStem single infusion 1-2 days following ischemic stroke Biological: Placebo single infusion 1-2 days following ischemic stroke

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436487

Contacts

Contact: Medpace Inc

(866) 872-2349

recruitment@medpace.com

Locations

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

Sponsors and Collaborators

Athersys, Inc

Medpace, Inc.

Investigators

Study Director:

Robert W Mays, PhD

Athersys, Inc

More Information

No publications provided

Responsible Party:	Athersys, Inc
ClinicalTrials.gov Identifier:	NCT01436487 History of Changes
Other Study ID Numbers:	B01-02
Study First Received:	September 15, 2011
Last Updated:	October 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Athersys, Inc:

ischemic stroke
adult stem cells

Additional relevant MeSH terms:

Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2012