ATHERSYS, INC. — Department of Health and Human Services STTR Phase I: DESCRIPTION (provided by applicant): This is a resubmission of a Phase I-Phase II Fast-Tra
ATHERSYS, INC. — STTR Phase I award from Department of Health and Human Services.
- Amount
- $224,721
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- STTR · Phase I
- Solicitation
- PA13-235
- NAICS
- —
- Place of performance
- OH
- Period
- —
Description
DESCRIPTION (provided by applicant): This is a resubmission of a Phase I-Phase II Fast-Track application for the clinical use of MultiStem in patients with acute respiratory distress syndrome (ARDS). ARDS is defined as acute onset hypoxemia, bilateral radiographic pulmonary infiltrates and lack of atrial pressure hypertension. A novel and exiting possibility is the use of cells as part of the therapy in lung injury. We and other groups have demonstrated that exogenous infusion of isolated mesenchymal stem cells (B-MSC) prevents inflammation and aberrant repair after lung injury. These and other observations suggest that B-MSC is a potentially safe and effective therapeutic intervention in lung injury. Progress toward B-MSC as a cell therapy for ARDS in humans requires completion of preclinical studies and validation in animal models. We propose to evaluate the therapeutic effect of a GMP-produced human adherent bone marrow derived stem cell (MultiStem) in a sheep model of endotoxin-induced moderate-sever