MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) - MASTERS-2

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001680-69-DE

Enrollment

300

Registered

2020-09-28

Start date

2021-05-17

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke MedDRA version: 22.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: MultiStem Product Code: PR1 Pharmaceutical Form: Suspension for suspension for injection INN or Proposed INN: Invimestrocel Other descriptive name: MultiStem

allogeneic bone-marrow derived multipotent adult progenitor cells ex-vivo expanded Concentration unit: Other Concentration type: equal Concentration number: 20000000- Pharmaceutical form of the placeb

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of MultiStem on functional outcome in subjects with ischemic stroke.;Secondary Objective: - To evaluate the efficacy of MultiStem on functional, neurological, mortality, secondary infection, and hospitalization outcomes in subjects with ischemic stroke; and - To evaluate the safety of MultiStem in subjects with ischemic stroke.;Primary end point(s): mRS score;Timepoint(s) of evaluation of this end point: Day 90	—

Measure

Time frame

Main Objective: Evaluate the efficacy of MultiStem on functional outcome in subjects with ischemic stroke.;Secondary Objective: - To evaluate the efficacy of MultiStem on functional, neurological, mortality, secondary infection, and hospitalization outcomes in subjects with ischemic stroke; and - To evaluate the safety of MultiStem in subjects with ischemic stroke.;Primary end point(s): mRS score;Timepoint(s) of evaluation of this end point: Day 90

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Secondary

Measure	Time frame
Secondary end point(s): 1.proportion of subjects achieving an excellent functional outcome at Day 365 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] 2.proportion of subjects achieving an excellent functional outcome at Day 90 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] 3.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 at Day 90;Timepoint(s) of evaluation of this end point: 1. 365 days 2. 90 days 3. 90 days	—

Measure

Time frame

Secondary end point(s): 1.proportion of subjects achieving an excellent functional outcome at Day 365 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] 2.proportion of subjects achieving an excellent functional outcome at Day 90 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] 3.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 at Day 90;Timepoint(s) of evaluation of this end point: 1. 365 days 2. 90 days 3. 90 days

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Countries

Australia, Germany, Netherlands, Portugal, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactAthersys Clinical Trials Group

Athersys Inc

masters2@athersys.com+12164263597

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026