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OpenTrials
Terminated

NCT Number: NCT03545607

MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

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.

Why the study stopped: Sponsor's decision
Terminated

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Athersys Investigational Site 603, Taichung, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MultiStem

Biological

single intravenous infusion 18-36 hours after stroke

Placebo

Biological

single intravenous infusion 18-36 hours after stroke

Primary outcomes

  1. 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

Secondary outcomes

  1. 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]

  2. proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:

    Time frame: 90 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]

  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

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Healios K.K.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

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

Acronym: MASTERS-2

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2018
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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