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NCT Number: NCT04898088

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

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.

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Key information

Conditions

COVID-19 Pneumonia COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal Stem Cells Transplantation

Biological

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

Primary outcomes

  1. Expression of PARP1 gene as indicator of base excision repair

    Time frame: 6 months

    Expression of PARP1 gene as indicator of base excision repair

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Other

Collaborators

  • Istinye University
  • Liv Hospital (Ulus)

Registry information

Acronym: REPAIR

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 24, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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