Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection

Multiple Organ Dysfunction Syndrome Clinical Trial

Official title:

Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552848
• Other study ID #: 2018005
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2019
• Source: Fujian Medical University
• Contact: Zhihuang Qiu, M.D
• Phone: 86 13805065508
• Email: qzhflm[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Part 1:

• Patients who are diagnosed with ATAAD and received emergency surgery with ascending aortic replacement combined with open placement of triple-branched stent graft

• elder than 60 years old

• Preoperative PaO2/FiO2 > 400mmHg, platelets = 150*109/L, bilirubin < 20µmol/L, no hypotension (without vasoactive drugs), Glasgow Coma Score Scale = 15, creatine <110µmol/L

Part 2:

• Patients who are diagnosed with ATAAD and received emergency surgery with ascending aortic replacement combined with open placement of triple-branched stent graft

• Patients who have failure of at least 2 organs

• Patients who meet the criteria as below:

sequential organ failure assessment score (SOFA) = 10

Exclusion Criteria:

• uncontrollable underlying disease life expectancy of less than 4 days history of long-term corticosteroid use during the past 6 months.

• The pre-operative computer tomography angiography(CTA) demonstrate the visceral arteries are involved

• pre-existing severe disease of any major organs

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Syndrome

Intervention

Biological:
• MSC
MSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times

Locations

Country	Name	City	State
China	Department of Cardiovascular Surgery	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival after intervention	survival after intervention: comparing survival ratio in hospital(6 months post-intervention) between groups.	Up to 6 month
Primary	adverse events	short term adverse events such as anaphylactic reaction, embolism; long term adverse events, such as oncogenicity	Up to 2 years
Primary	sequential organ failure assessment score(SOFA)	Compare the change of sequential organ failure assessment score(SOFA) between groups.	Up to 6 months
Primary	interleukin-6	Compare the change of interleukin( IL)-6 between groups.	Early 3 days
Secondary	the effects on kidney function	the therapeutic effects in the improvement of kidney function, as indicated by Scr level.	Up to 6 months
Secondary	the effects on liver function	the therapeutic effects in the improvement of liver function, as indicated by bilirubin levels.	Up to 6 months
Secondary	the effects on lung function	the therapeutic effects in the improvement of lung function, as indicated by oxygenation index.	Up to 6 months
Secondary	the effects on coagulation function	the therapeutic effects in the improvement of coagulation function, as indicated by blood platelet count.	Up to 6 months
Secondary	the effects on central nervous system	the therapeutic effects in the improvement of coagulation function, as indicated by Glosgow coma score	Up to 6 months