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

A

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

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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