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

Not Applicable

Completed

• Conditions: COVID-19 Pneumonia
• Interventions: Biological: Mesenchymal Stem Cells Transplantation

• Registration Number: NCT04898088
• Lead Sponsor: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

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:

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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-09-30
• Status Verified: 2021-05
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Therapy	Mesenchymal Stem Cells Transplantation	-
Conventional Therapy with Add-On MSC therapy	Mesenchymal Stem Cells Transplantation	-

Primary Outcome Measures

Name	Time	Method
Expression of PARP1 gene as indicator of base excision repair	6 months	Expression of PARP1 gene as indicator of base excision repair
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair	6 months	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	6 months	Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair	6 months	Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair

Trial Locations

Locations (2)

Istinye University; 🇹🇷 Istanbul, Turkey

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey