A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Biological: MultiStemBiological: Placebo
- Registration Number
- NCT02611609
- Lead Sponsor
- Healios K.K.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- Concurrent illness that shortens life expectancy to less than 6 months
- Other serious medical or psychiatric illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 Placebo Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo Cohort 2 MultiStem High dose MultiStem Cohort 1 MultiStem Low dose MultiStem Cohort 3 MultiStem Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo
- Primary Outcome Measures
Name Time Method Frequency of sustained hypoxemia or hypotension 4 hours Suspected Unexpected Serious Adverse Reactions (SUSARs) 24 hours
- Secondary Outcome Measures
Name Time Method Frequency of adverse events Up to 365 days Changes in vital signs Up to 7 days Ventilator-free days 28 days ICU-free days 28 days Total length of hospital stay 28 days All-cause mortality Up to Day 365 Changes in blood safety laboratories Up to 7 days Changes in levels of oxygenation Up to 28 days Changes in positive end-expiratory airway pressure Up to 28 days Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) Up to Day 365
Trial Locations
- Locations (10)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
St. Georges Hospital
🇬🇧London, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
University Hospitals - Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom