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

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ClinicalTrials.gov Identifier: NCT03552848
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Liang-Wan Chen MD, Fujian Medical University

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.

Condition or disease Intervention/treatment Phase
Multiple Organ Dysfunction Syndrome Biological: MSC Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Part 1: totally 30 patient will be enrolled, and 15 patients will be given MSC immediately after ascending aortic replacement combined with open placement of triple-branched stent graft for ATAAD.

Part 2: totally 30 patient will be enrolled, and 15 patients will be given MSC after onset of multiple organ dysfuntion syndrome after ascending aortic replacement combined with open placement of triple-branched stent graft for ATAAD.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection: a Pilot Study
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: Mesenchymal stem cell
Patients in the MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight.
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

No Intervention: Control
Patients in the control arm will not be given MSC.



Primary Outcome Measures :
  1. survival after intervention [ Time Frame: Up to 6 month ]
    survival after intervention: comparing survival ratio in hospital(6 months post-intervention) between groups.

  2. adverse events [ Time Frame: Up to 2 years ]
    short term adverse events such as anaphylactic reaction, embolism; long term adverse events, such as oncogenicity

  3. sequential organ failure assessment score(SOFA) [ Time Frame: Up to 6 months ]
    Compare the change of sequential organ failure assessment score(SOFA) between groups.

  4. interleukin-6 [ Time Frame: Early 3 days ]
    Compare the change of interleukin( IL)-6 between groups.


Secondary Outcome Measures :
  1. the effects on kidney function [ Time Frame: Up to 6 months ]
    the therapeutic effects in the improvement of kidney function, as indicated by Scr level.

  2. the effects on liver function [ Time Frame: Up to 6 months ]
    the therapeutic effects in the improvement of liver function, as indicated by bilirubin levels.

  3. the effects on lung function [ Time Frame: Up to 6 months ]
    the therapeutic effects in the improvement of lung function, as indicated by oxygenation index.

  4. the effects on coagulation function [ Time Frame: Up to 6 months ]
    the therapeutic effects in the improvement of coagulation function, as indicated by blood platelet count.

  5. the effects on central nervous system [ Time Frame: Up to 6 months ]
    the therapeutic effects in the improvement of coagulation function, as indicated by Glosgow coma score



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552848


Contacts
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Contact: Zhihuang Qiu, M.D 86 13805065508 qzhflm@126.com

Locations
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China, Fujian
Department of Cardiovascular Surgery Recruiting
Fuzhou, Fujian, China, 350001
Contact: Liang-Wan Chen, M.D, Ph.D    86 13358255333    daixiaofu719@hotmail.com   
Contact: E Lin, M.D    86 13365912195    1470054258@qq.com   
Sponsors and Collaborators
Fujian Medical University
Investigators
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Principal Investigator: Liangwan Chen, M.D Union Hospital

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Responsible Party: Liang-Wan Chen MD, Department Director, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03552848     History of Changes
Other Study ID Numbers: 2018005
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Syndrome
Multiple Organ Failure
Disease
Pathologic Processes
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Shock