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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
Sponsor:
Information provided by (Responsible Party):
Liang-Wan Chen MD, Fujian Medical University

Brief Summary:
Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction syndrome (MODS) after cardiac surgery is a life-threatening condition. In this study, patients who are unresponsive to conventional treatment will be treated with umbilical cord-derived mesenchymal stem cell.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome (ARDS) Multiple Organ Failure Biological: MSC Not Applicable

Detailed Description:

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 .


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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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Mesenchymal stem cell
Patients in MSC arm will be given MSC, i.v., 1000000 cells per kilogram of body weight.
Biological: MSC
MSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times




Primary Outcome Measures :
  1. survival after surgery [ Time Frame: Up to 2 years ]
    survival after surgery. Comparing the difference between the historical survival ratio of the hospital


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have failure of at least 2 organs
  • Patients who meet the criteria as below:

blood gas parameters of PaO2/FiO2 < 100 100% oxygen demand in case of ventilation sequential organ failure assessment score (SOFA) ≥ 10 multiple organ dysfunction (MOD) score ≥ 10

Exclusion Criteria:

  • uncontrollable underlying disease life expectancy of less than 4 days history of long-term corticosteroid use during the past 6 months.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhihuang Qiu, M.D 86 13805065508 qzhflm@126.com

Locations
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China, Fujian
Department of Cardiovascular Surgery
Fuzhou, Fujian, China, 350001
Sponsors and Collaborators
Fujian Medical University
Investigators
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Principal Investigator: Liangwan Chen, M.D Union Hospital

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Responsible Party: Liang-Wan Chen MD, Department Director, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03552848     History of Changes
Other Study ID Numbers: 2018005
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Multiple Organ Failure
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Shock