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

May 21, 2021 updated by: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34010
        • Istinye University
      • Istanbul, Turkey, 34147
        • SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Therapy
Biological: Mesenchymal Stem Cells Transplantation
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Experimental: Conventional Therapy with Add-On MSC therapy
Biological: Mesenchymal Stem Cells Transplantation
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of PARP1 gene as indicator of base excision repair
Time Frame: 6 months
Expression of PARP1 gene as indicator of base excision repair
6 months
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Time Frame: 6 months
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
6 months
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
Time Frame: 6 months
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
6 months
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
Time Frame: 6 months
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Collaborators

Istinye University
Liv Hospital (Ulus)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8860/9193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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