Multiple Organ FailureNCT04356300
Exosome of Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection
A study testing Exosome of MSC in people with Multiple Organ Failure, run by Fujian Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Multiple Organ Failure
- What is being tested?
- Exosome of MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Patients who have failure of at least 2 organs
- Patients who meet the criteria as below:
- sequential organ failure assessment score (SOFA) ≥ 10
Who cannot join
- • 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exosome of Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection: a Pilot Study
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.
Read the detailed description
Multiple organ dysfunction syndrome (MODS) are common debilitating complications after surgical repaired 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. There is increasing evidence that MSCs function in a paracrine manner. Exosomes have been reported to activate signaling pathways by binding to receptors. Compared with mesenchymal stem cells, exosomes are more stable and storable and no risk of aneuploidy. The possibility of immune rejection after allogeneic administration of exosomes is lower and can provide alternative treatment for a variety of diseases.
The trial contains two parts:
Part one (prevention scheme):to explore the safety and efficacy of exosome of MSC, the investigators will recruit patients who are diagnosed with ATAAD, and 15 participants will be administrated intravenously with exosome of MSC immediately after ascending aortic replacement combined with open placement of triple branched stent graft while other 15 not. Then the investigators will monitor participants' MODS related biochemical indexes, sequential organ failure assessment (SOFA) scores, comparing to those don't be treated with exosome of 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, the investigators will randomly use exosome of MSC to 15 of participants while other 15 not. Then the investigators will monitor participants' MODS related biochemical indexes, SOFA scores, comparing to those don't be treated with MSC. The dosage of the exosome of MSC was determined on the basis of the previous clinical studies, which is 180mg once a time and administrated intravenously.
- Conditions
- Multiple Organ Failure
- Being tested
- Exosome of MSC
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome of MSCBiological
Exosome of MSC at a dose of 150mg will be given intravenously to patients once a day for 14 times.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Exosome of MSC |
| The control arm | No intervention | Patients in the control arm will not be given exosome of MSC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival after intervention
comparing survival ratio in hospital(6 months post-intervention) between groups.
Measured: 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.
Measured: Up to 6 months
interleukin-6
Compare the change of concentration of interleukin( IL)-6 between groups.
Measured: 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.
Measured: Up to 6 months
The number of people who get cancer
The number of people diagnosed with cancer after treatment
Measured: Up to 2 years
Secondary outcomes (5)
the effects on kidney function
the therapeutic effects in the improvement of kidney function, as indicated by Scr level.
Measured: Up to 6 months
the effects on liver function
the therapeutic effects in the improvement of liver function, as indicated by bilirubin levels.
Measured: Up to 6 months
the effects on lung function
the therapeutic effects in the improvement of lung function, as indicated by oxygenation index.
Measured: Up to 6 months
the effects on coagulation function
the therapeutic effects in the improvement of coagulation function, as indicated by blood platelet count.
Measured: Up to 6 months
the effects on central nervous system
The Glasgow coma scale has a maximum score of 15 and a minimum score of 3, indicating consciousness. 12-14 was classified as mild consciousness disorder; 9-11 was classified as moderate disturbance of consciousness; A score below 8 is coma; The lower the score, the greater the disturbance of consciousness.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang-Wan Chen MD, Fujian Medical University
- Investigators
- Liang-wan Chen, M.D, Principal investigator, Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356300
- Sponsor's protocol ID
- 2020005
- Status last verified
- May 2020
- First submitted
- 19 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome of Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection: a Pilot Study
- ClinicalTrials.gov ID
- NCT04356300
- Acronym / sponsor ID
- 2020005
- Conditions
- Multiple Organ Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple organ dysfunction syndrome (MODS) are common debilitating complications after surgical repaired 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. There is increasing evidence that MSCs function in a paracrine manner. Exosomes have been reported to activate signaling pathways by binding to receptors. Compared with mesenchymal stem cells, exosomes are more stable and storable and no risk of aneuploidy. The possibility of immune rejection after allogeneic administration of exosomes is lower and can provide alternative treatment for a variety of diseases.
The trial contains two parts:
Part one (prevention scheme):to explore the safety and efficacy of exosome of MSC, the investigators will recruit patients who are diagnosed with ATAAD, and 15 participants will be administrated intravenously with exosome of MSC immediately after ascending aortic replacement combined with open placement of triple branched stent graft while other 15 not. Then the investigators will monitor participants' MODS related biochemical indexes, sequential organ failure assessment (SOFA) scores, comparing to those don't be treated with exosome of 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, the investigators will randomly use exosome of MSC to 15 of participants while other 15 not. Then the investigators will monitor participants' MODS related biochemical indexes, SOFA scores, comparing to those don't be treated with MSC. The dosage of the exosome of MSC was determined on the basis of the previous clinical studies, which is 180mg once a time and administrated intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The exosome of MSC arm | Experimental | Biological: Exosome of MSCExosome 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. |
| The control arm | No intervention | –Patients in the control arm will not be given exosome of MSC. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Patients who have failure of at least 2 organs
- Patients who meet the criteria as below:
- sequential organ failure assessment score (SOFA) ≥ 10
Key exclusion criteria (3 listed)
- • uncontrollable underlying disease life expectancy of less than 4 days history of long-term corticosteroid use during the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosome of MSCExosome of MSC at a dose of 150mg will be given intravenously to patients once a day for 14 times. | Biological | The exosome of MSC arm |
Primary outcome
survival after intervention
Time frame: Up to 6 month
comparing survival ratio in hospital(6 months post-intervention) between groups.
sequential organ failure assessment score
Time frame: Up to 6 months
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.
interleukin-6
Time frame: Early 3 days
Compare the change of concentration of interleukin( IL)-6 between groups.
The number of allergic reactions
Time frame: Up to 6 months
Allergic reactions are mostly manifested as skin flushing, rash and itching. Severe allergic reactions such as chills, high fever and anaphylactic shock are rare.
The number of people who get cancer
Time frame: Up to 2 years
The number of people diagnosed with cancer after treatment
5 secondary outcomes
the effects on kidney function
Time frame: Up to 6 months
the effects on liver function
Time frame: Up to 6 months
the effects on lung function
Time frame: Up to 6 months
the effects on coagulation function
Time frame: Up to 6 months
the effects on central nervous system
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang-wan Chen, M.D principal investigator
Union Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Exosome of MSC in people with Multiple Organ Failure, run by Fujian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Kun Jiang (86-14759926068, 869582567@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival after intervention (time frame: Up to 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.