Ischemic StrokePhase 2NCT01436487
Study to Examine the Effects of MultiStem in Ischemic Stroke
A Phase 2 study testing MultiStem in people with Ischemic Stroke, run by Healios K.K. at 32 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- MultiStem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Oct 2011to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States26 sites
Summa Health System
Akron, Ohio, 44320
Georgia Regents University
Augusta, Georgia, 30912
Boston University
Boston, Massachusetts, 02118
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
Case Western Reserve University School of Medicine
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Palmetto Health Richland
Columbia, South Carolina, 29203
Henry Ford Health System
Detroit, Michigan, 48202
The Pennsylvania State University
Hershey, Pennsylvania, 17033-0850
Methodist Hospital Research Institute
Houston, Texas, 77030
The University of Texas Health Science Center
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Kentucky Medical Center
Lexington, Kentucky, 40536
UCLA Medical Center
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2045
Florida Hospital Orlando
Orlando, Florida, 32803
Hospital for the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84132
Stanford University
Stanford, California, 94305
United Kingdom6 sites
University of Glasgow - Western Infirmary
Glasgow, G11 6NT
University of Glasgow - Southern General Hospital
Glasgow, G12 8QQ
St. Georges Healthcare NHS Trust
London, SW17 0QT
University College London Hospitals - Thames Stroke Research Network
London, WC1E 6BT
The Newcastle upon Tyne Hospitals, NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke
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.
- Conditions
- Ischemic Stroke
- Being tested
- MultiStem, Placebo
- Keywords
- ischemic stroke, adult stem cells
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiStemBiological
single infusion 1-2 days following ischemic stroke
PlaceboBiological
single infusion 1-2 days following ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Low dose MultiStem or Placebo Receives: Biological: MultiStem; Biological: Placebo |
| Cohort 2 | Experimental | High dose MultiStem or Placebo Receives: Biological: MultiStem; Biological: Placebo |
| Cohort 3 | Experimental | Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo Receives: Biological: MultiStem; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of dose limiting adverse events
Measured: 7 days
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
Measured: 90 days
Secondary outcomes (8)
proportion of subjects with a mRS score of less than or equal to 2
Measured: 90 days
change in functional outcome throughout range of mRS scores
Measured: 90 days
changes in outcome measures (mRS, NIHSS, BI) over time
Measured: 365 days
proportion of subjects with an excellent functional outcome
- mRS score = 0 to 1; and
- NIHSS score = 0 to 1; and
- Barthel Index score = greater than or equal to 95
Measured: 90 days
frequency of adverse events
Measured: 365 days
change in vital signs
Measured: 365 days
change in safety labs
Measured: 365 days
frequency of secondary infections
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healios K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert W Mays, PhD, Study director, Healios K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436487
- Sponsor's protocol ID
- B01-02
- Status last verified
- Jul 2016
- First submitted
- 15 Sep 2011
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, Yavagal DR, Uchino K, Liebeskind DS, Auchus AP, Sen S, Sila CA, Vest JD, Mays RW. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 May;16(5):360-368. doi: 10.1016/S1474-4422(17)30046-7. Epub 2017 Mar 17.
PubMed 28320635
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01436487
- Acronym / sponsor ID
- B01-02
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, adult stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Healios K.K.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MultiStem, Biological: PlaceboLow dose MultiStem or Placebo |
| Cohort 2 | Experimental | Biological: MultiStem, Biological: PlaceboHigh dose MultiStem or Placebo |
| Cohort 3 | Experimental | Biological: MultiStem, Biological: PlaceboHighest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultiStemsingle infusion 1-2 days following ischemic stroke | Biological | Cohort 1, Cohort 2, Cohort 3 |
| Placebosingle infusion 1-2 days following ischemic stroke | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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
8 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Derived from this study: PubMed 28320635Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, Yavagal DR, Uchino K, Liebeskind DS, Auchus AP, Sen S, Sila CA, Vest JD, Mays RW. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 May;16(5):360-368. doi: 10.1016/S1474-4422(17)30046-7. Epub 2017 Mar 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Mays, PhD study director
Healios K.K.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MultiStem in people with Ischemic Stroke, run by Healios K.K. at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of dose limiting adverse events (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01436487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.