Stem cell therapy for sepsis or septic shock caused by pneumonia
Research type
Research Study
Full title
A phase Ib/IIa, randomised, double blind, parallel group, placebo controlled, multicentre study to assess the safety and efficacy of Cx611 expanded allogeneic adipose-derived stem cells (eASCs) for the intravenous treatment of adult patients with a severe community-acquired bacterial pneumonia and admitted to the intensive care unit. SEPCELL study.
IRAS ID
235534
Contact name
Amit Patel
Contact email
Sponsor organisation
TiGenix
Eudract number
2015-002994-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Sepsis is a life-threatening condition associated with organ failure (dysfunction), affecting more than 250,000 patients in the UK. Sepsis is caused by an abnormal patient immune response to infection. The commonest cause of infection is bacterial and affects the lungs (pneumonia). Sadly up to 40% of sepsis victims die; more deaths per year than from bowel, breast, and prostate cancer combined. Patients that survive often have long-term disability and reduced quality of life after leaving hospital. Thus an urgent need remains for new treatments targeting the abnormal patient immune response to infection characterising sepsis to improve patient survival and limit organ failure.
This study proposes to evaluate the safety and potential patient benefit of cellular therapy (Cx611) for sepsis and septic shock (the most severe form of sepsis associated with fatality in over 40%) caused by pneumonia. Potential mechanisms of patient benefit will also be studied. Cx611 may help to beneficially re-programme the abnormal patient immune response to sepsis, and contribute to bacterial clearance by enhanced killing by the immune system. Cx611 is produced from mesenchymal stromal stem cells present in and grown from fat tissue (eASCs) obtained from healthy volunteer donors. These frozen cells are available ready to use "off the shelf" and usually only persist in a patient's blood for a few days before being removed. Sepsis mandates urgent treatment to prevent life-threatening organ failure and death, so Cx611 therapy needs to be given as soon as sepsis is diagnosed, within an intensive/critical care unit. After the consent process, patients will be assigned with equal probability to receive either two 20-30 minute infusions into a vein, of Cx611 or placebo, while they receive standard NHS treatment including prompt antibiotics and supportive care for failing organs necessary to maintain adequate breathing and blood pressure levels.
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0366
Date of REC Opinion
26 Jan 2018
REC opinion
Further Information Favourable Opinion