A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome (MUST-ARDS)

Athersys

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Respiratory Distress Syndrome

Treatments: Biological: Placebo; Biological: MultiStem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02611609

B04-01

Details and patient eligibility

About

A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.

Enrollment: 36 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of moderate to severe ARDS, as defined by the Berlin definition, requiring an endotracheal or tracheal tube
• Able to receive investigational medicinal product within 96 hours of meeting the last of the ARDS diagnosis criterion

Exclusion criteria

• Concurrent illness that shortens life expectancy to less than 6 months
• Other serious medical or psychiatric illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Low dose MultiStem

Treatment:

Biological: MultiStem

Cohort 2

Experimental group

Description:

High dose MultiStem

Treatment:

Biological: MultiStem

Cohort 3

Experimental group

Description:

Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo

Treatment:

Biological: MultiStem

Biological: Placebo