Mesenchymal stromal cell (MSC) transplantation in septic shock.

Phase 2

Withdrawn

• Conditions: septisch shock; septic shock and severe blood poisoning; 10027665; 10002252

• Registration Number: NL-OMON39173
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients between 18 and 75 years, fulfilling the criteria for pneumonia septic shock. ;(see chapter 4.2 and Appendix B of the research protocol)

Exclusion Criteria

Moribund and where death is imminent, pregnancy, inflammatory diseases from any other origin then sepsis, chronic pulmonary or kidney disorders, active malignancies, single organ or other stem cell transplantations and participation in other clinical intervention studies. ;(see section 4.3 of the research protocol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters: the dose of norepinephrine and the systolic blood pressure<br /><br>at specified time points.<br /><br><br /><br>The primary outcome measure: shock-reversal time.<br /><br><br /><br>Definition: the reversal of shock is defined as the maintenance of systolic<br /><br>blood pressure of at least 90 mmHg without vasopressor support for at least 24<br /><br>hours as described earlier.<br /><br><br /><br>(See section 8.1 of the research protocol)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br><br /><br>1. treatment related toxicity<br /><br>2. systemic immune cell response<br /><br>3. disease severity and outcome<br /><br><br /><br>(See for detailed description section 8.2 and 8.3 of the research protocol)</p><br>