Study to Examine the Effects of MultiStem in Ischemic Stroke
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| ClinicalTrials.gov Identifier: NCT01436487 |
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Recruitment Status :
Completed
First Posted : September 19, 2011
Last Update Posted : August 2, 2016
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Sponsor:
Athersys, Inc
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Stroke | Biological: MultiStem Biological: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 134 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | December 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Ischemic Stroke
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1
Low dose MultiStem or Placebo
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Biological: MultiStem
single infusion 1-2 days following ischemic stroke Biological: Placebo single infusion 1-2 days following ischemic stroke |
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Experimental: Cohort 2
High dose MultiStem or Placebo
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Biological: MultiStem
single infusion 1-2 days following ischemic stroke Biological: Placebo single infusion 1-2 days following ischemic stroke |
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Experimental: Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
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Biological: MultiStem
single infusion 1-2 days following ischemic stroke Biological: Placebo single infusion 1-2 days following ischemic stroke |
Primary Outcome Measures :
- frequency of dose limiting adverse events [ Time Frame: 7 days ]
- Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) [ Time Frame: 90 days ]
Secondary Outcome Measures :
- proportion of subjects with a mRS score of less than or equal to 2 [ Time Frame: 90 days ]
- change in functional outcome throughout range of mRS scores [ Time Frame: 90 days ]
- changes in outcome measures (mRS, NIHSS, BI) over time [ Time Frame: 365 days ]
- 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
- frequency of adverse events [ Time Frame: 365 days ]
- change in vital signs [ Time Frame: 365 days ]
- change in safety labs [ Time Frame: 365 days ]
- frequency of secondary infections [ Time Frame: 365 days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 83 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436487
Locations
Show 32 study locations
Sponsors and Collaborators
Athersys, Inc
Medpace, Inc.
Investigators
| Study Director: | Robert W Mays, PhD | Athersys, Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Athersys, Inc |
| ClinicalTrials.gov Identifier: | NCT01436487 |
| Other Study ID Numbers: |
B01-02 |
| First Posted: | September 19, 2011 Key Record Dates |
| Last Update Posted: | August 2, 2016 |
| Last Verified: | July 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Athersys, Inc:
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ischemic stroke adult stem cells |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |