Effect of Mesenchymal Stromal Cells on Sepsis and Septic Shock
The Effect of Mesenchymal Stromal Cells on the Mortality of Patients With Sepsis and Septic Shock: A Promising Therapy
1 other identifier
interventional
30
1 country
1
Brief Summary
Methods:Ten patients were enrolled in the study. Adipose derived-MSCs infusions were given (1x 106/ kg, on 1st, 3rd, 5th, 7th and 9th days of therapy) together with Standard therapy. Before the MSCs applications, blood samples were collected for cytokine assessment (TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10). The clinical and laboratory improvements were recorded and compared with control groups selected retrospectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 sepsis
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2019
CompletedFirst Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedMarch 16, 2022
March 1, 2022
1.5 years
February 18, 2022
March 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Survival rates of the study group patients were compared with the survival rates of previous observational study conducted in the same Intensive Care Units (ICUs) as control.
28th days were determined as survival status and endpoint.
Secondary Outcomes (1)
Length of stay in the hospital
Through study completion, an average of 1 year
Study Arms (2)
Patients received MSCs
ACTIVE COMPARATOR10 patients with sepsis and septic shock and received MSCs\&standart therapy
Patients not received MSCs
NO INTERVENTION20 patients with sepsis and septic shock and not received MSCs, only received standart therapy
Interventions
Standard therapy of sepsis as suggested in the guidelines were given to all patients and additionally MSCs treatment was applied to the patients in the study group.
Eligibility Criteria
You may qualify if:
- sepsis and septic shock
- years of age
You may not qualify if:
- \<18-year-old and \> 80 years old
- pregnant women or breast-feeding;
- terminal stage of cancer,
- advanced pulmonary disease receiving oxygen at home,
- advanced pulmonary hypertension (WHO Class III or IV),
- advanced heart failure (American Heart Association Class III or IV),
- severe liver disease (Child C),
- history of anaphylaxis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University
Kayseri, Turkey (Türkiye)
Related Publications (1)
Alp E, Gonen ZB, Gundogan K, Esmaoglu A, Kaynar L, Cetin A, Karakukcu M, Cetin M, Kalin G, Doganay M. The Effect of Mesenchymal Stromal Cells on the Mortality of Patients with Sepsis and Septic Shock: A Promising Therapy. Emerg Med Int. 2022 Jun 24;2022:9222379. doi: 10.1155/2022/9222379. eCollection 2022.
PMID: 35784641DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emine ALP MESE, Professor
TC Erciyes University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 16, 2022
Study Start
March 11, 2018
Primary Completion
August 25, 2019
Study Completion
November 13, 2019
Last Updated
March 16, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share