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Adult Stem Cell Therapy

MultiStem for Ischemic Stroke (MASTERS-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Athersys, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

MASTERS-2 Trial Summary

This trial is testing whether an investigational stem cell product is safe and effective in treating adults who have had a stroke.

Eligible Conditions
  • Ischemic Stroke
  • Stroke

MASTERS-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
Secondary outcome measures
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria
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

MASTERS-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MultiStemExperimental Treatment1 Intervention
1.2 billion cells
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MultiStem
2016
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Athersys, IncLead Sponsor
10 Previous Clinical Trials
929 Total Patients Enrolled
1 Trials studying Ischemic Stroke
134 Patients Enrolled for Ischemic Stroke
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,345 Total Patients Enrolled
1 Trials studying Ischemic Stroke
134 Patients Enrolled for Ischemic Stroke
Robert W Mays, PhDStudy DirectorAthersys, Inc
1 Previous Clinical Trials
134 Total Patients Enrolled
1 Trials studying Ischemic Stroke
134 Patients Enrolled for Ischemic Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a study like this ever been conducted before?

"Since 2017, there has been ongoing research into MultiStem. The first clinical trial occurred in 2017 and was sponsored by Healios K.K. After the initial trial involving 220 people, MultiStem received approval for Phase 2 & 3 clinical trials. There are currently 4 active trials across 22 cities and 3 countries."

Answered by AI

In how many different areas is this study being conducted?

"Patients are being accepted at the Athersys Investigational Site 127 in Sacramento, California, Athersys Investigational Site 102 in Portland, Oregon, Athersys Investigational Site 111 in Jackson, Mississippi, and 23 other locations."

Answered by AI

What is the maximum number of people who can be a part of this test?

"That is correct, according to the latest information available on clinicaltrials.gov, this clinical trial is still looking for participants. 23 different medical centres are involved in the trial, and the goal is to have 300 patients total. The trial was first posted on July 28, 2018."

Answered by AI

Are there other examples of MultiStem being used in research?

"Currently, there are 4 ongoing studies investigating MultiStem with 3 trials in Phase 3. While several of the trials for MultiStem are based in Phoenix, Arizona, there are 32 locations operating trials for MultiStem."

Answered by AI

Are there any current vacancies for this research program?

"That is accurate. The clinical trial was posted on 7/28/2018 and was last updated on 2/8/2022. The trial is looking for 300 patients from 23 different sites."

Answered by AI

Has the FDA cleared MultiStem for use in the United States?

"There is already some clinical data supporting the efficacy of MultiStem, as well as multiple rounds of data that suggest it is safe, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Athersys Investigational Site 122
Athersys Investigational Site 106
Athersys Investigational Site 118
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I’m getting married soon, and hoping to be as best I can be for my wedding, I’ve been looking for a treatment for a long time now.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Is it a long stay ?
PatientReceived 2+ prior treatments
~45 spots leftby Mar 2025