MultiStem Administration for Stroke Treatment and Enhanced Recovery

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    268864

  • Contact name

    Anand Dixit

  • Contact email

    anand.dixit@nhs.net

  • Sponsor organisation

    Athersys, Inc.

  • Eudract number

    2019-001680-69

  • Clinicaltrials.gov Identifier

    NCT03545607

  • Duration of Study in the UK

    1 years, 9 months, 23 days

  • Research summary

    An ischemic stroke, also commonly called a Cerebrovascular Accident (CVA), happens when the blood flow through the blood vessel(s) supplying your brain is blocked by a clot (group of blood cells that stick together, forming a clump), and no blood and oxygen can reach the affected area in your brain.

    This study is evaluating the benefit and potential side effects of an investigational human stem cell product called MultiStem (cell therapy) to treat strokes.

    Approximately 300 subjects who have experienced an acute cortical ischemic stroke and fulfill all the eligibility criteria will be enrolled into the study in approximately 60 sites in the world.

    This is a Phase 3, randomized, double-blind, placebo-controlled study, menaning neither their participant nor the study doctor will know which medication is being given.

    The total study duration for safety follow-up will be 12 months.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    21/SC/0017

  • Date of REC Opinion

    14 Jun 2021

  • REC opinion

    Further Information Favourable Opinion