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

NCT04356300 | Not Yet Recruiting

• 1 other identifier: 2020005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiple organ dysfunction syndrome (MODS) after surgical repaired for acute type A aortic dissection (ATAAD) is a life-threatening condition. In this study, patients who undergoing surgical repaired of ATAAD immediately or presenting sever MODS after surgical repaired of acute type A aortic dissection will be treated with umbilical cord-derived mesenchymal stem cell.

Conditions

Multiple Organ Failure

Outcome Measures

Primary Outcomes (5)

• survival after intervention

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

  Up to 6 month

• sequential organ failure assessment score

  Compare the change of sequential organ failure assessment score between groups. Scores ranged from 0 to 24. The higher the score, the worse the prognosis.

  Up to 6 months

• interleukin-6

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

  Early 3 days

• The number of allergic reactions

  Allergic reactions are mostly manifested as skin flushing, rash and itching. Severe allergic reactions such as chills, high fever and anaphylactic shock are rare.

  Up to 6 months

• The number of people who get cancer

  The number of people diagnosed with cancer after treatment

  Up to 2 years

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)

The exosome of MSC arm

EXPERIMENTAL

Exosome of MSC at a dose of 150mg will be given intravenously to Patients in the exosome of MSC arm once a day for 14 times.

Biological: Exosome of MSC

The control arm

NO INTERVENTION

Patients in the control arm will not be given exosome of MSC.

Interventions

Exosome of MSC BIOLOGICAL

Exosome of MSC at a dose of 150mg will be given intravenously to patients once a day for 14 times.

The exosome of MSC arm

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

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang-wan Chen, M.D

  Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Kun Jiang

CONTACT

86-14759926068; 869582567@qq.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 Exosomes of MSCs 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 Exosomes of 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: April 19, 2020
• First Posted: April 22, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share