Treatment of sepsis using human umbilical cord stem cells
Clinical Study on Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Sepsis
EARLY_PHASE1 · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · NCT06882811
This study is testing if giving people with sepsis infusions of stem cells from umbilical cords can help them survive better than those who receive a standard treatment.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 0 Years to 65 Years |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (other) |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06882811 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intravenous infusions of universal umbilical cord mesenchymal stem cells (UC-MSCs) and a specific subpopulation of CD83+ MSCs in treating sepsis. The primary goal is to assess the 28-day survival rate of participants diagnosed with sepsis, while secondary objectives include evaluating the safety of these stem cells and providing data for future clinical treatment plans. Participants will receive either the stem cell treatment or a control solution to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 0-65 years who have been diagnosed with sepsis based on established clinical guidelines.
Not a fit: Patients with severe underlying health conditions, imminent terminal status, or active drug-resistant infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients suffering from sepsis.
How similar studies have performed: While the use of stem cells in treating sepsis is a novel approach, similar studies have shown promising results in related areas, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 0-65 years old, diagnosed with sepsis * Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines) * Confirmed or suspected infection Exclusion Criteria: * Violation of medical ethics * Significant confounding factors likely to bias study outcomes * Poor adherence to the study protocol * Concurrent participation in other clinical trials * Specific medical conditions: 1. History of chronic enteritis, neuropsychiatric disorders, or transplantation (bone marrow, lung, liver, pancreas, or small intestine) 2. Severe primary diseases affecting survival (e.g., life-limiting hepatic, renal, or endocrine disorders) or psychiatric disorders 3. History of hypersensitivity or severe adverse reactions to biological products 4. Imminent terminal status (e.g., septic shock, life expectancy \<7 days) 5. Foreseeable risk of medical errors or disputes during hospitalization 6. Active drug-resistant infections 7. History of malignancy at screening 8. Pregnancy, lactation, or plans for pregnancy within the next year
Where this trial is running
Chongqing, Chongqing Municipality
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Xiang Xu, Professor
- Email: xiangxu@tmmu.edu.cn
- Phone: +8613637843870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis