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

NCT ID: NCT04898088

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Therapy

Group Type EXPERIMENTAL

Mesenchymal Stem Cells Transplantation

Intervention Type BIOLOGICAL

Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals

Conventional Therapy with Add-On MSC therapy

Group Type EXPERIMENTAL

Mesenchymal Stem Cells Transplantation

Intervention Type BIOLOGICAL

Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals

Interventions

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Mesenchymal Stem Cells Transplantation

Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istinye University

OTHER

Sponsor Role collaborator

Liv Hospital (Ulus)

UNKNOWN

Sponsor Role collaborator

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istinye University

Istanbul, , Turkey (Türkiye)

Site Status

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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8860/9193

Identifier Type: -

Identifier Source: org_study_id

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