COVID-19 PneumoniaREPAIRNCT04898088
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
A study testing Mesenchymal Stem Cells Transplantation in people with COVID-19 Pneumonia, run by SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Mesenchymal Stem Cells Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-65 years old male/female.
- Obtaining informed consent from him or his legal relative.
- Confirmed COVID-19 related severe ARDS cases.
Who cannot join
- pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istinye University
Istanbul, 34010
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, 34147
About this study
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:
- Base excision repair
- Nucleotide excision repair
- Recombinational repair
- Mismatch repair
- Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
Read the 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:
- Base excision repair
- Nucleotide excision repair
- Recombinational repair
- Mismatch repair
- Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Mesenchymal Stem Cells Transplantation
- Keywords
- COVID-19, Critical Case, DNA Repair, DAN damage
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells TransplantationBiological
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Experimental | Not described Receives: Biological: Mesenchymal Stem Cells Transplantation |
| Conventional Therapy with Add-On MSC therapy | Experimental | Not described Receives: Biological: Mesenchymal Stem Cells Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of PARP1 gene as indicator of base excision repair
Expression of PARP1 gene as indicator of base excision repair
Measured: 6 months
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
Measured: 6 months
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
Measured: 6 months
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jan 2020
- Primary completion30 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University, Liv Hospital (Ulus)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898088
- Sponsor's protocol ID
- 8860/9193
- Acronym
- REPAIR
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04898088
- Acronym / sponsor ID
- REPAIR / 8860/9193
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, Critical Case, DNA Repair, DAN damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma HastanesiUniversity, hospital or other
- Collaborators
- Istinye University, Liv Hospital (Ulus)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Base excision repair
- Nucleotide excision repair
- Recombinational repair
- Mismatch repair
- 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:
- Base excision repair
- Nucleotide excision repair
- Recombinational repair
- Mismatch repair
- Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Experimental | Biological: Mesenchymal Stem Cells Transplantation |
| Conventional Therapy with Add-On MSC therapy | Experimental | Biological: Mesenchymal Stem Cells Transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-65 years old male/female.
- Obtaining informed consent from him or his legal relative.
- Confirmed COVID-19 related severe ARDS cases.
Key exclusion criteria (1 listed)
- pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem Cells TransplantationMesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals | Biological | Conventional Therapy, Conventional Therapy with Add-On MSC therapy |
Primary outcome
Expression of PARP1 gene as indicator of base excision repair
Time frame: 6 months
Expression of PARP1 gene as indicator of base excision repair
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Time frame: 6 months
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
Time frame: 6 months
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
Time frame: 6 months
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal Stem Cells Transplantation in people with COVID-19 Pneumonia, run by SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of PARP1 gene as indicator of base excision repair (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.