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Completed

NCT Number: NCT01436487

Study to Examine the Effects of MultiStem in 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.

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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–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Glasgow - Southern General Hospital, Glasgow, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MultiStem

Biological

single infusion 1-2 days following ischemic stroke

Placebo

Biological

single infusion 1-2 days following ischemic stroke

Primary outcomes

  1. frequency of dose limiting adverse events

    Time frame: 7 days

  2. Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)

    Time frame: 90 days

Secondary outcomes

  1. proportion of subjects with a mRS score of less than or equal to 2

    Time frame: 90 days

  2. change in functional outcome throughout range of mRS scores

    Time frame: 90 days

  3. changes in outcome measures (mRS, NIHSS, BI) over time

    Time frame: 365 days

  4. proportion of subjects with an excellent functional outcome

    Time frame: 90 days

    • mRS score = 0 to 1; and
    • NIHSS score = 0 to 1; and
    • Barthel Index score = greater than or equal to 95

  5. frequency of adverse events

    Time frame: 365 days

  6. change in vital signs

    Time frame: 365 days

  7. change in safety labs

    Time frame: 365 days

  8. frequency of secondary infections

    Time frame: 365 days

Sponsors and collaborators

Lead sponsor

Healios K.K.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2011
Registry last updated
Aug 2, 2016

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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