First Patient Enrolled In Japan In Study Of Treatment For ARDS.
CLEVELAND, Ohio, April 23, 2019 -- Athersys, Inc. (NASDAQ: ATHX) announced that its partner Japanese partner Healios K.K. has enrolled the first patient in its ONE-BRIDGE study in Japan evaluating MultiStem cell therapy treatment of patients who suffer from acute respiratory distress syndrome (ARDS).
The clinical trial is testing the efficacy and safety of MultiStem therapy for patients with pneumonia-induced ARDS.
The trial will enroll 30 patients with 20 receiving the cell therapy treatment and standard of care and 10 receiving standard therapy alone.
The primary endpoint will be the number of days in which the patient was not on a ventilator in the 28 days following the treatment.
In June 2018, Healios agreed to expand its collaboration with Athersys into additional therapeutic areas. Healios obtained an exclusive license for the development and commercialization in Japan of MultiStem therapy for the treatment of ARDS.
In January 2019, Athersys announced positive results from its exploratory Phase 1/2 ARDS clinical study.
The results further confirmed the tolerability and safety of the cell therapy and demonstrated the potential for benefits in mortality, ventilator-free days and ICU-free days.
The Athersys trial results will be presented at the upcoming 2019 ATS International Conference on May 20 in Dallas.
Acute respiratory distress syndrome (ARDS) is a serious immunological and inflammatory condition characterized by widespread inflammation in the lungs.
ARDS can be triggered by pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting.
It has significant implications, as it prolongs intensive care unit and hospital stays and requires convalescence in the hospital and rehabilitation.
There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs. Given ARDS high treatment costs, a successful cell therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU and importantly, could reduce mortality and improve quality of life for those suffering from the condition.
The medical need for a safe and effective treatment of ARDS is significant due to its high mortality rate, and it affects annually approximately 400,000 to 500,000 patients in Europe, the U.S., and Japan.
MultiStem cell therapy has shown in preclinical studies it can reduce inflammation, support tissue regeneration, and promote homeostasis in acute immunological and injury settings.
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||The Latest News...|
|Publication:||Stem Cell Lab World|
|Date:||Apr 29, 2019|
|Previous Article:||First Subjects Dosed In Phase 1 Trial Of Stem Cell Mobilization Factor.|
|Next Article:||Updated Phase 2a Results For First Stem Cell Trial In ACLF.|