A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT02611609

Run by

Healios K.K.

People needed

36

Starts

2016-01-01

Expected to finish

2019-07-01

Last updated by the study team

2019-11-20

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• University Hospitals - Cleveland Medical Center — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Queen Elizabeth Hospital — Birmingham, United Kingdom
• Addenbrooke's Hospital — Cambridge, United Kingdom
• University College London Hospital — London, United Kingdom
• St. Georges Hospital — London, United Kingdom
• Manchester Royal Infirmary — Manchester, United Kingdom
• Wythenshawe Hospital — Manchester, United Kingdom
• John Radcliffe Hospital — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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