Multiple Organ Dysfunction SyndromeNCT03552848
Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection
A study testing MSC in people with Multiple Organ Dysfunction Syndrome, run by Fujian Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Multiple Organ Dysfunction Syndrome
- What is being tested?
- MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery
Fuzhou, Fujian, 350001
Liang-Wan Chen, M.D, Ph.D, 86 13358255333, daixiaofu719@hotmail.com
E Lin, M.D, 86 13365912195, 1470054258@qq.com
About this study
Official title: 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 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.
Read the 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 .
- Conditions
- Multiple Organ Dysfunction Syndrome
- Being tested
- 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.
MSCBiological
MSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell | Experimental | Patients in the MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight. Receives: Biological: MSC |
| Control | No intervention | Patients in the control arm will not be given MSC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival after intervention
survival after intervention: comparing survival ratio in hospital(6 months post-intervention) between groups.
Measured: Up to 6 month
adverse events
short term adverse events such as anaphylactic reaction, embolism; long term adverse events, such as oncogenicity
Measured: Up to 2 years
sequential organ failure assessment score(SOFA)
Compare the change of sequential organ failure assessment score(SOFA) between groups.
Measured: Up to 6 months
interleukin-6
Compare the change of interleukin( IL)-6 between groups.
Measured: Early 3 days
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 therapeutic effects in the improvement of coagulation function, as indicated by Glosgow coma score
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 posted12 Jun 2018
- Study start1 Jul 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ Dysfunction SyndromeStudies 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 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 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
- Liangwan Chen, M.D, Principal investigator, Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552848
- Sponsor's protocol ID
- 2018005
- Status last verified
- Jun 2019
- First submitted
- 29 May 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- 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 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome After Surgical Repaire of Acute Type A Aortic Dissection: a Pilot Study
- ClinicalTrials.gov ID
- NCT03552848
- Acronym / sponsor ID
- 2018005
- Conditions
- Multiple Organ Dysfunction Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 12 Jun 2018 (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 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.
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 .
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 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.
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell | Experimental | Biological: MSCPatients in the MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight. |
| Control | No intervention | –Patients in the control arm will not be given 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)
- 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
- Patients who have failure of at least 2 organs
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.
- The pre-operative computer tomography angiography(CTA) demonstrate the visceral arteries are involved
- pre-existing severe disease of any major organs
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 |
|---|---|---|
| MSCMSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times | Biological | Mesenchymal stem cell |
Primary outcome
survival after intervention
Time frame: Up to 6 month
survival after intervention: comparing survival ratio in hospital(6 months post-intervention) between groups.
adverse events
Time frame: Up to 2 years
short term adverse events such as anaphylactic reaction, embolism; long term adverse events, such as oncogenicity
sequential organ failure assessment score(SOFA)
Time frame: Up to 6 months
Compare the change of sequential organ failure assessment score(SOFA) between groups.
interleukin-6
Time frame: Early 3 days
Compare the change of interleukin( IL)-6 between groups.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- 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. This study is not recruiting at the moment.
Liangwan Chen, M.D principal investigator
Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSC in people with Multiple Organ Dysfunction Syndrome, run by Fujian Medical University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihuang Qiu, M.D (86 13805065508, qzhflm@126.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 4 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 18 Jun 2019.