TerminatedPhase 3

MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Stopped: Sponsor's decision

United States, Taiwan206 participantsStarted 2018-07-28

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis

Timeframe: 90 days

Trial details

NCT IDNCT03545607

SponsorHealios K.K.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Ischemic Stroke trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.