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MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

NCT03545607 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-02-09

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

MultiStem

single intravenous infusion 18-36 hours after stroke

BIOLOGICAL

Placebo

single intravenous infusion 18-36 hours after stroke

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Healios K.K.

    lead INDUSTRY

Principal Investigators

  • Robert W Mays, PhD · Healios K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-28
Primary Completion
2022-09-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545607 on ClinicalTrials.gov