MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Phase 3

• Conditions: Ischemic Stroke

• Registration Number: NCT03545607
• Lead Sponsor: Healios K.K.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-06-04
• Study Start: 2018-07-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09
• Primary Completion: 2022-09
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis	90 days

Secondary Outcome Measures

Name	Time	Method
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	90 days
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:	90 days	mRS score = 0 to 1 \[scale range 0 to 6\]; and NIHSS score = 0 to 1 \[scale range 0 to 42\]; and Barthel Index score = greater than or equal to 95 \[scale range 0 to 100\]

Trial Locations

Locations (26)

Athersys Investigational Site 128; 🇺🇸 Phoenix, Arizona, United States

Athersys Investigational Site 122; 🇺🇸 Palo Alto, California, United States

Athersys Investigational Site 127; 🇺🇸 Sacramento, California, United States

Athersys Investigational Site 129; 🇺🇸 Clearwater, Florida, United States

Athersys Investigational Site 108; 🇺🇸 Miami, Florida, United States

Athersys Investigational Site 103; 🇺🇸 Augusta, Georgia, United States

Athersys Investigational Site 121; 🇺🇸 Chicago, Illinois, United States

Athersys Investigational Site 119; 🇺🇸 Kansas City, Kansas, United States

Athersys Investigational Site 124; 🇺🇸 Wichita, Kansas, United States

Athersys Investigational Site 113; 🇺🇸 Boston, Massachusetts, United States

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