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

Healios

Status and phase: Unknown; Phase 3

Conditions: Ischemic Stroke

Treatments: Biological: Placebo; Biological: MultiStem

Study type: Interventional

Funder types: Industry

Identifiers

NCT03545607

B01-04

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 2 patient groups, including a placebo group

MultiStem

Experimental group

Description:

1.2 billion cells

Treatment:

Biological: MultiStem

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo