Mesenchymal Stem Cells for Multiple Organ Failure After Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03552848|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome (ARDS) Multiple Organ Failure||Biological: MSC||Not Applicable|
Acute respiratory distress syndrome (ARDS) with multi-organ dysfunction syndrome (MODS) are common debilitating complications after cardiac surgery. Despite recent advance in surgical technique, mortality rate remains high in such critical care conditions.
There is a growing body of experimental evidence that mesenchymal stem (stromal) cells (MSC) may be effective in treating critically ill surgical patients who develop multiorgan dysfunction with ARDS, acute renal failure, and secondary infections. Therefore, in the present pilot study, the investigators hypothesized that timely initiation of MSC will positively influence ventilation in and survival of patients with ARDS in combination with MODS.
The indication for MSC was unresponsive severe ARDS in combination with MODS when all the other treatment modalities such as intravenous steroid administration, nitric oxide inhalation, or high-frequency oscillatory ventilation performed within 20 days were unsuccessful.
The dosage of the MSC was determined on the basis of the previous clinical studies, which is 100000 cells per kilogram of body weight and administrated intervenously .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||15 patients will be given MSC.|
|Masking:||None (Open Label)|
|Official Title:||Mesenchymal Stem Cells for Multiple Organ Failure With Acute Respiratory Distress Syndrome After Cardiac Surgery: a Pilot Study|
|Estimated Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||September 1, 2018|
Experimental: Mesenchymal stem cell
Patients in MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight.
MSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times
- survival after surgery [ Time Frame: Up to 2 years ]survival after surgery. Comparing the difference between the historical survival ratio of the hospital
- the effects on kidney function [ Time Frame: Up to 2 years ]the therapeutic effects in the improvement of kidney function, as indicated by Scr level.
- the effects on liver function [ Time Frame: Up to 2 years ]the therapeutic effects in the improvement of liver function, as indicated by aspartate aminotransferase and alanine transaminase levels.
- the effects on lung function [ Time Frame: Up to 2 years ]the therapeutic effects in the improvement of lung function, as indicated by surplus pulse O2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552848
|Contact: Zhihuang Qiu, M.D||86 firstname.lastname@example.org|
|Department of Cardiovascular Surgery|
|Fuzhou, Fujian, China, 350001|
|Principal Investigator:||Liangwan Chen, M.D||Union Hospital|