Multiple Organ Failure Clinical Trial
Official title:
Exosome of Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection: a Pilot Study
Multiple organ dysfunction syndrome (MODS) after surgical repaired for acute type A aortic dissection (ATAAD) is a life-threatening condition. In this study, patients who undergoing surgical repaired of ATAAD immediately or presenting sever MODS after surgical repaired of acute type A aortic dissection will be treated with umbilical cord-derived mesenchymal stem cell.
Multiple organ dysfunction syndrome (MODS) are common debilitating complications after
surgical repaired for ATAAD. MODS is one of the chief causes of post-operative death for
acute type A aortic dissection (ATAAD) patients, and it was reported that MODS accounted for
more than half of the death after surgery for ATAAD. Despite recent advance in surgical
technique, mortality rate remains high in such critical care conditions. In animal models,
studies have demonstrated the beneficial effects of MSCs with respect to ischemia-reperfusion
injury of heart, lungs, kidney, brains and livers. Several pilot studies have provided
evidence that MSC may be effective in treating critically ill patients with traumatic brain
injury, acute renal failure, or acute respiratory distress syndrome. There is increasing
evidence that MSCs function in a paracrine manner. Exosomes have been reported to activate
signaling pathways by binding to receptors. Compared with mesenchymal stem cells, exosomes
are more stable and storable and no risk of aneuploidy. The possibility of immune rejection
after allogeneic administration of exosomes is lower and can provide alternative treatment
for a variety of diseases.
The trial contains two parts:
Part one (prevention scheme):to explore the safety and efficacy of exosome of MSC, the
investigators will recruit patients who are diagnosed with ATAAD, and 15 participants will be
administrated intravenously with exosome of MSC immediately after ascending aortic
replacement combined with open placement of triple branched stent graft while other 15 not.
Then the investigators will monitor participants' MODS related biochemical indexes,
sequential organ failure assessment (SOFA) scores, comparing to those don't be treated with
exosome of MSC.
Phase two (treatment scheme): for patients presenting severe MODS (SOFA scoreā„10) after
ascending aortic replacement combined with open placement of triple-branched stent graft, the
investigators will randomly use exosome of MSC to 15 of participants while other 15 not. Then
the investigators will monitor participants' MODS related biochemical indexes, SOFA scores,
comparing to those don't be treated with MSC. The dosage of the exosome of MSC was determined
on the basis of the previous clinical studies, which is 180mg once a time and administrated
intravenously.
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