A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
NCT ID: NCT04898088
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-01-01
2020-09-30
Brief Summary
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Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:
1. Base excision repair
2. Nucleotide excision repair
3. Recombinational repair
4. Mismatch repair
5. Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
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Detailed Description
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Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:
1. Base excision repair
2. Nucleotide excision repair
3. Recombinational repair
4. Mismatch repair
5. Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Therapy
Mesenchymal Stem Cells Transplantation
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Conventional Therapy with Add-On MSC therapy
Mesenchymal Stem Cells Transplantation
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Interventions
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Mesenchymal Stem Cells Transplantation
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Eligibility Criteria
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Inclusion Criteria
2. Obtaining informed consent from him or his legal relative.
3. Confirmed COVID-19 related severe ARDS cases.
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Istinye University
OTHER
Liv Hospital (Ulus)
UNKNOWN
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
OTHER
Responsible Party
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Locations
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Istinye University
Istanbul, , Turkey (Türkiye)
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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8860/9193
Identifier Type: -
Identifier Source: org_study_id
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