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

NCT ID: NCT03552848

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-12-01

Brief 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.

Detailed 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 .

Conditions

Multiple Organ Dysfunction Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mesenchymal stem cell

Patients in the MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight.

Group Type: EXPERIMENTAL

MSC

Intervention Type: BIOLOGICAL

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

Control

Patients in the control arm will not be given MSC.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MSC

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Liang-Wan Chen MD

Department Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liangwan Chen, M.D

Role: PRINCIPAL_INVESTIGATOR

Union Hospital

Locations

Department of Cardiovascular Surgery

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhihuang Qiu, M.D

Role: CONTACT

qzhflm@126.com

86 13805065508

Facility Contacts

Liang-Wan Chen, M.D, Ph.D

Role: primary

daixiaofu719@hotmail.com

86 13358255333

E Lin, M.D

Role: backup

1470054258@qq.com

86 13365912195

Other Identifiers

2018005

Identifier Type: -

Identifier Source: org_study_id