A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients (REPAIR)
Primary Purpose
COVID-19 Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mesenchymal Stem Cells Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, Critical Case, DNA Repair, DAN damage
Eligibility Criteria
Inclusion Criteria:
- 40-65 years old male/female.
- Obtaining informed consent from him or his legal relative.
- Confirmed COVID-19 related severe ARDS cases.
Exclusion Criteria:
pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents
Sites / Locations
- Istinye University
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional Therapy
Conventional Therapy with Add-On MSC therapy
Arm Description
Outcomes
Primary Outcome Measures
Expression of PARP1 gene as indicator of base excision repair
Expression of PARP1 gene as indicator of base excision repair
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
Secondary Outcome Measures
Full Information
NCT ID
NCT04898088
First Posted
May 21, 2021
Last Updated
May 21, 2021
Sponsor
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Collaborators
Istinye University, Liv Hospital (Ulus)
1. Study Identification
Unique Protocol Identification Number
NCT04898088
Brief Title
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
Acronym
REPAIR
Official Title
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Collaborators
Istinye University, Liv Hospital (Ulus)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes.
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:
Base excision repair
Nucleotide excision repair
Recombinational repair
Mismatch repair
Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
Detailed Description
Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes.
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:
Base excision repair
Nucleotide excision repair
Recombinational repair
Mismatch repair
Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
COVID-19, Critical Case, DNA Repair, DAN damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Therapy
Arm Type
Experimental
Arm Title
Conventional Therapy with Add-On MSC therapy
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stem Cells Transplantation
Intervention Description
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Primary Outcome Measure Information:
Title
Expression of PARP1 gene as indicator of base excision repair
Description
Expression of PARP1 gene as indicator of base excision repair
Time Frame
6 months
Title
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Description
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Time Frame
6 months
Title
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
Description
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
Time Frame
6 months
Title
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
Description
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
40-65 years old male/female.
Obtaining informed consent from him or his legal relative.
Confirmed COVID-19 related severe ARDS cases.
Exclusion Criteria:
pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents
Facility Information:
Facility Name
Istinye University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Facility Name
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
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