A safety and efficacy study of Multistem Cell Therapy for ARDS
Research type
Research Study
Full title
A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem Therapy in Subjects with Acute Respiratory Distress Syndrome
IRAS ID
177212
Contact name
Manal Morsy
Contact email
Sponsor organisation
Athersys, Ltd
Eudract number
2015-001586-96
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Acute respiratory distress syndrome (ARDS) is a common condition which is a major cause of admittance to critical care setting and has a significant mortality rate. MultiStem cell therapy is being developed for the treatment of Acute Respiratory Distress Syndrome (ARDS). MultiStem is a cell therapy medicinal product originating from stem cells taken from the bone marrow of a nonrelated donor and expanded outside of the donor’s body.
There will be three different treatment groups within the trial, each will be treated up to 96 hour after being diagnosed with ARDS. Group 1 (3 subjects) will be dosed with 300 million cells, Group 2 (3 subjects) with 900 million cells. Group 3 (30 subjects) will be given either the same dose as group 1 or as group 2 depending on the decision made by doctors from looking at safety data from both groups. Group 3 will be blinded and placebo controlled. Neither the doctor nor the subject will know if the Multistem or dummy drug will be administered. The MultiStem cell therapy will be given to the subjects as a drip, much like you would a blood transfusion. 20 subjects will receive the Multistem cell therapy and 10 subjects will receive a dummy drug.
All subjects will be monitored closely to make sure that they are safe. A number of tests will take place between day 4 to day 28, including blood tests and tests to measure how well their lungs are doing. The subjects will take part in the trial for 365 days.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1079
Date of REC Opinion
22 Sep 2015
REC opinion
Further Information Favourable Opinion