An interventional study of MSC in Multiple Organ Dysfunction Syndrome, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by Fujian Medical University · Not applicable, Interventional, and Treatment
Multiple organ dysfunction syndrome (MODS) after surgical repaire for acute type A aortic dissection(ATAAD) is a life-threatening condition. In this study, patients who undergoing surgical repaire of ATAAD immdediately or presenting sever MODS after surgical repaire 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 repaire 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. Therefore, in the present pilot study, the investigators hypothesized that timely initiation of mesenchymal stem cells(MSC) will positively influence survival and biochemical indexesof patients with MODS after ascending aortic replacement combined with open placement of triple-branched stent graft for ATAAD. The trial contain two parts:
Part one(prenvention scheme): to explore the safety and efficacy of umbilical cord-derived MSC, we will recruit patients who are diagnosed with ATAAD, and 8 patients will be administrated intervenously with MSC immediately after ascending aortic replacement combined with open placement of triple-branched stent graft while other 8 not. Then we will monitor their MODS related biochemical indexes, sequential organ failure assessment(SOFA) scores, comparing to those don't be treated with MSC.
Phase two(treatment scheme): for patients presenting severe MODS(SOFA score≥10) after ascending aortic replacement combined with open placement of triple-branched stent graft, we will randomly use MSC to 8 of patients while other 8 not. Then we will monitor their MODS related biochemical indexes, SOFA scores, comparing to those don't be treated with MSC.
The dosage of the MSC was determined on the basis of the previous clinical studies, which is 1000000 cells per kilogram of body weight and administrated intervenously .
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.
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Part 1:
Part 2:
sequential organ failure assessment score (SOFA) ≥ 10
Exclusion Criteria:
Patients in the MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight.
Biological: MSC
Patients in the control arm will not be given MSC.
MSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times
survival after intervention
survival after intervention: comparing survival ratio in hospital(6 months post-intervention) between groups.
Time frame: Up to 6 month
adverse events
short term adverse events such as anaphylactic reaction, embolism; long term adverse events, such as oncogenicity
Time frame: Up to 2 years
sequential organ failure assessment score(SOFA)
Compare the change of sequential organ failure assessment score(SOFA) between groups.
Time frame: Up to 6 months
interleukin-6
Compare the change of interleukin( IL)-6 between groups.
Time frame: Early 3 days
the effects on kidney function
the therapeutic effects in the improvement of kidney function, as indicated by Scr level.
Time frame: Up to 6 months
the effects on liver function
the therapeutic effects in the improvement of liver function, as indicated by bilirubin levels.
Time frame: Up to 6 months
the effects on lung function
the therapeutic effects in the improvement of lung function, as indicated by oxygenation index.
Time frame: Up to 6 months
the effects on coagulation function
the therapeutic effects in the improvement of coagulation function, as indicated by blood platelet count.
Time frame: Up to 6 months
the effects on central nervous system
the therapeutic effects in the improvement of coagulation function, as indicated by Glosgow coma score
Time frame: Up to 6 months
Plan to share: No
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Fujian Medical University