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

NCT03552848 | Unknown

• 1 other identifier: 2018005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Organ Dysfunction Syndrome

Outcome Measures

Primary Outcomes (4)

• survival after intervention

  survival after intervention: comparing survival ratio in hospital(6 months post-intervention) between groups.

  Up to 6 month

• adverse events

  short term adverse events such as anaphylactic reaction, embolism; long term adverse events, such as oncogenicity

  Up to 2 years

• sequential organ failure assessment score(SOFA)

  Compare the change of sequential organ failure assessment score(SOFA) between groups.

  Up to 6 months

• interleukin-6

  Compare the change of interleukin( IL)-6 between groups.

  Early 3 days

Secondary Outcomes (5)

• the effects on kidney function

  Up to 6 months

• the effects on liver function

  Up to 6 months

• the effects on lung function

  Up to 6 months

• the effects on coagulation function

  Up to 6 months

• the effects on central nervous system

  Up to 6 months

Study Arms (2)

Mesenchymal stem cell

EXPERIMENTAL

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

Biological: MSC

Control

NO INTERVENTION

Patients in the control arm will not be given MSC.

Interventions

MSC BIOLOGICAL

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

Mesenchymal stem cell

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Cardiovascular Surgery

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liangwan Chen, M.D

  Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihuang Qiu, M.D

CONTACT

86 13805065508; qzhflm@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)