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

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Status: Completed

Conditions: COVID-19 Pneumonia

Treatments: Biological: Mesenchymal Stem Cells Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04898088

8860/9193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Conventional Therapy

Experimental group

Treatment:

Biological: Mesenchymal Stem Cells Transplantation

Conventional Therapy with Add-On MSC therapy

Experimental group

Treatment:

Biological: Mesenchymal Stem Cells Transplantation