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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

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