EU-funded project SEPCELL will conduct a clinical trial of a stem cell treatment for patients with severe sepsis caused by a severe form of community-acquired bacterial pneumonia. The trial is one of a series of steps in assessing whether the treatment is safe and efficacious for patients with this life-threatening disease.
Sepsis is an inflammatory and potentially life-threatening response of the body to infection. Severe sepsis is further complicated by acute organ dysfunction. Patients with the condition currently have a low survival rate, so there is a critical need to improve the effectiveness of current therapies.
Severe sepsis and septic shock are two of the leading causes of mortality in intensive care units. This is increasing due to an ageing of the population, an increase in drug-resistant bacteria and the weakening of the immune system caused by several factors.
SEPCELL is investigating treatment with a type of stem cells that can regulate the immune system, has anti-inflammatory properties, and possesses antimicrobial capacities. The project consortium believes that therapy with a type of 'allogeneic adipose-derived mesenchymal stem cells' (ASCs) could be a possible treatment, added to standard of care in intensive care units, for patients who have severe sepsis as a result of pneumonia acquired outside of a hospital.
This type of bacterial pneumonia, known as 'community-acquired pneumonia' (CAP), is a leading cause of severe sepsis. Mortality rates can range from 28% to 50%.
ASCs may be an innovative therapeutic approach to re-establishing the normal immune response in such patients, as well as a means to reduce injury to organs and restore their functions, the project says.
SEPCELL is expected to perform a Phase Ia/IIb clinical trial on 180 patients across Europe to test this possibility.