Ischemic StrokePhase 3MASTERS-2NCT03545607
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
A Phase 3 study testing MultiStem in people with Ischemic Stroke, run by Healios K.K. at 26 sites in 2 countries.
Trial summary
A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 206 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 28 Jul 2018to 1 Oct 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- Male or female subjects ≥18 years of age
- Clinical diagnosis of ischemic stroke involving cerebral cortex
- Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
- A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke
Primary Exclusion Criteria:
- Presence of a lacunar or a brainstem infarct
- Comatose state
- Brain hemorrhage
- Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States23 sites
Athersys Investigational Site 109
Akron, Ohio, 44304
Athersys Investigational Site 103
Augusta, Georgia, 30912
Athersys Investigational Site 113
Boston, Massachusetts, 02114
Athersys Investigational Site 115
Chattanooga, Tennessee, 37403
Athersys Investigational Site 121
Chicago, Illinois, 60201
Athersys Investigational Site 129
Clearwater, Florida, 33756
Athersys Investigational Site 104
Cleveland, Ohio, 44195
Athersys Investigational Site 118
Columbia, South Carolina, 29203
Athersys Investigational Site 107
Hershey, Pennsylvania, 17033
Athersys Investigational Site 101
Houston, Texas, 77030
Athersys Investigational Site 105
Houston, Texas, 77030
Athersys Investigational Site 111
Jackson, Mississippi, 39216
Athersys Investigational Site 119
Kansas City, Kansas, 66160
Athersys Investigational Site 108
Miami, Florida, 33136
Athersys Investigational Site 125
Minneapolis, Minnesota, 55455
Athersys Investigational Site 122
Palo Alto, California, 94304
Athersys Investigational Site 128
Phoenix, Arizona, 85013
Athersys Investigational Site 106
Pittsburgh, Pennsylvania, 15213
Athersys Investigational Site 102
Portland, Oregon, 97239
Athersys Investigational Site 127
Sacramento, California, 95817
Athersys Investigational Site 110
Salt Lake City, Utah, 84112
Athersys Investigational Site 130
Toledo, Ohio, 43606
Athersys Investigational Site 124
Wichita, Kansas, 67214
Taiwan3 sites
Athersys Investigational Site 603
Taichung, 40402
Athersys Investigational Site 601
Taipei, 10002
Athersys Investigational Site 602
Taoyuan City, 33305
About this study
Official title: MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.
- 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 intravenous infusion 18-36 hours after stroke
PlaceboBiological
single intravenous infusion 18-36 hours after stroke
| Study group | Role | What they receive |
|---|---|---|
| MultiStem | Experimental | 1.2 billion cells Receives: Biological: MultiStem |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
Measured: 90 days
Secondary outcomes (3)
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100]
Measured: 365 days
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100]
Measured: 90 days
proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start28 Jul 2018
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Sponsor's decision
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 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
- NCT03545607
- Sponsor's protocol ID
- B01-04
- Acronym
- MASTERS-2
- Status last verified
- Aug 2026
- First submitted
- 23 May 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
- ClinicalTrials.gov ID
- NCT03545607
- Acronym / sponsor ID
- MASTERS-2 / B01-04
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, adult stem cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Healios K.K.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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 Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MultiStem | Experimental | Biological: MultiStem1.2 billion cells |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 intravenous infusion 18-36 hours after stroke | Biological | MultiStem |
| Placebosingle intravenous infusion 18-36 hours after stroke | Biological | Placebo |
Primary outcome
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
Time frame: 90 days
3 secondary outcomes
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
Time frame: 365 days
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
Time frame: 90 days
proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: 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: Undecided
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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.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MultiStem in people with Ischemic Stroke, run by Healios K.K. at 26 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?
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: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Taiwan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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?
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis (time frame: 90 days). 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 NCT03545607, 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 11 Aug 2026.