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Clinical Trials List

Protocol NumberB01-04
NCT Number(ClinicalTrials.gov Identfier)NCT03545607
Completed

2020-11-30 - 2025-12-31

Phase III

Recruiting3

ICD-10Z82.3

Family history of stroke

ICD-9V17.1

Family history of stroke ( cerebrovascular )

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

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

    Athersys, Inc

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/01

Investigators and Locations

Principal Investigator Tsong-Hai Lee Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Woei-Cheang Shyu Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator LI-KAI TSAI Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

acute ischemic stroke

Objectives

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.

Test Drug

MultiStem

Active Ingredient

MultiStem cell

Dosage Form

IV infusion

Dosage

about 2x10^7 cell/mL；33.5 mL/vial

Endpoints

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 ]

proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ Time Frame: 365 days ]
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]

Inclution Criteria

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

Exclusion Criteria

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

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    300 participants

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