Clinical trial NCT04898088: A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
Official title: A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: COVID-19
Critical Case
DNA Repair
DAN damage
Lead sponsor: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Sponsor class: OTHER
Collaborators: name: Istinye University
name: Liv Hospital (Ulus)
First posted: 2021-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Expression of PARP1 gene as indicator of base excision repair
timeFrame: 6 months
measure: Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
timeFrame: 6 months
measure: Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
timeFrame: 6 months
measure: Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
city: Istanbul
country: Turkey
facility: SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Study officials:
References: