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NCT04898088 Clinical Trial

A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients

COVID-19 Pneumonia Clinical Trial

— REPAIR  

Official title:
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04898088
Other study ID # 8860/9193
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date September 30, 2020

Study information
Verified date May 2021
Source SBÜ Dr. Sadi Konuk Egitim ve Arastirma Hastanesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 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.

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: 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. 40-65 years old male/female. 2. Obtaining informed consent from him or his legal relative. 3. 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Mesenchymal Stem Cells Transplantation
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals

Locations
Country Name City State
Turkey Istinye University Istanbul
Turkey SBÜ Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Istanbul

Sponsors (3)
Lead Sponsor Collaborator
SBÜ Dr. Sadi Konuk Egitim ve Arastirma Hastanesi Istinye University, Liv Hospital (Ulus)

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expression of PARP1 gene as indicator of base excision repair Expression of PARP1 gene as indicator of base excision repair 6 months
Primary 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 6 months
Primary Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair 6 months
Primary Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair 6 months
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