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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorFujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exosome of MSC

    Biological/Vaccine

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: The exosome of MSC armExperimental treatment 1 intervention
Group B: The control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

survival after intervention

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

Time frame
Up to 6 month
2

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.

Time frame
Up to 6 months
3

interleukin-6

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

Time frame
Early 3 days
4

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.

Time frame
Up to 6 months

Secondary outcomes

1

the effects on kidney function

the therapeutic effects in the improvement of kidney function, as indicated by Scr level.

Time frame
Up to 6 months
2

the effects on liver function

the therapeutic effects in the improvement of liver function, as indicated by bilirubin levels.

Time frame
Up to 6 months
3

the effects on lung function

the therapeutic effects in the improvement of lung function, as indicated by oxygenation index.

Time frame
Up to 6 months
4

the effects on coagulation function

the therapeutic effects in the improvement of coagulation function, as indicated by blood platelet count.

Time frame
Up to 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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