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History of Changes for Study: NCT01436487
Study to Examine the Effects of MultiStem in Ischemic Stroke
Latest version (submitted July 29, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 16, 2011 None (earliest Version on record)
2 October 21, 2011 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Oversight
3 August 22, 2013 Study Status, Contacts/Locations and Eligibility
4 February 28, 2014 Contacts/Locations and Study Status
5 March 31, 2014 Study Status
6 July 22, 2014 Study Status and Contacts/Locations
7 November 11, 2014 Study Status, Outcome Measures and Contacts/Locations
8 May 29, 2015 Recruitment Status, Study Status and Contacts/Locations
9 February 12, 2016 Recruitment Status and Study Status
10 July 29, 2016 Study Status, Study Design and IPDSharing
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Study NCT01436487
Submitted Date:  September 16, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: B01-02
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2011
Overall Status: Not yet recruiting
Study Start: September 2011
Primary Completion: October 2013 [Anticipated]
Study Completion: November 2014 [Anticipated]
First Submitted: September 15, 2011
First Submitted that
Met QC Criteria:
September 16, 2011
First Posted: September 19, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 16, 2011
Last Update Posted: September 19, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Athersys, Inc
Responsible Party: Sponsor
Collaborators: Medpace, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Ischemic Stroke
Keywords: ischemic stroke
adult stem cells
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1
Low dose MultiStem or Placebo
Biological: MultiStem
single infusion 24-36 hours following ischemic stroke
Biological: Placebo
single infusion 24-36 hours following ischemic stroke
Experimental: Cohort 2
High dose MultiStem or Placebo
Biological: MultiStem
single infusion 24-36 hours following ischemic stroke
Biological: Placebo
single infusion 24-36 hours following ischemic stroke
Experimental: Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Biological: MultiStem
single infusion 24-36 hours following ischemic stroke
Biological: Placebo
single infusion 24-36 hours following ischemic stroke
Open or close this module Outcome Measures
Primary Outcome Measures:
1. frequency of dose limiting adverse events
[ Time Frame: 7 days ]

2. proportion of subjects with a modified Rankin Scale (mRS) score of less than or equal to 2
[ Time Frame: 90 days ]

Secondary Outcome Measures:
1. change in functional outcome throughout range of mRS scores
[ Time Frame: 90 days ]

2. proportion of subjects with an excellent functional outcome
[ Time Frame: 90 days ]

  • mRS score = 0 to 1; and
  • NIHSS score = 0 to 1; and
  • Barthel Index score = greater than or equal to 95
3. frequency of adverse events
[ Time Frame: 365 days ]

4. change in vital signs
[ Time Frame: 365 days ]

5. change in safety labs
[ Time Frame: 365 days ]

6. frequency of secondary infections
[ Time Frame: 365 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 79 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Medpace Inc
Telephone: (866) 872-2349
Email: recruitment@medpace.com
Study Officials: Robert W Mays, PhD
Study Director
Athersys, Inc
Locations: United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Contact:Principal Investigator: David C Hess, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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