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

• Sponsor: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi (Other)
• Overall Status: Completed
• CT.gov ID: NCT04898088
• Collaborator: Istinye University (Other), Liv Hospital (Ulus) (Other)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site: 15
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Biological: Mesenchymal Stem Cells Transplantation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Aug 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Expression of PARP1 gene as indicator of base excision repair [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 [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 [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 [6 months]

   Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istinye University	Istanbul		Turkey	34010
2	SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi	Istanbul		Turkey	34147

Sponsors and Collaborators

• SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
• Istinye University
• Liv Hospital (Ulus)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
• ClinicalTrials.gov Identifier: NCT04898088
• Other Study ID Numbers: 8860/9193
• First Posted: May 24, 2021
• Last Update Posted: May 24, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi: COVID-19; Critical Case; DNA Repair; DAN damage
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 24, 2021