Coronavirus Disease 2019 (COVID-19) PneumoniaNCT04713878
Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
A study testing Mesenchymal stem cells in people with Coronavirus Disease 2019 (COVID-19) Pneumonia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 (COVID-19) infection, some patients hospitalization to intensive care cause of pneumonia, Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure. Mortality is higher in treatment-resistant cases. Purpose of this study: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19) Pneumonia
- What is being tested?
- Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2020to 15 Jul 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-90 male or female
- laboratory approve of RT-PCR (real-time reverse transcription polymerase chain reaction) with COVID-19 infection
- pneumonia assessed by chest radiography or computed tomography
- In accordance with any of the following: 1)Respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmHg, 4) pulmonary imaging of focus within 24-48 hours > 50% progression
- patients who remain unresponsive to medications administered according to Ministry of health guidelines
- Patients who receiving invasive or non-invasive mechanical ventilation therapy in intensive care
Who cannot join
- Pregnancy
- Any kind of cancer, severe liver disease
- Failure to provide informed consent or comply with test requirements
- Known allergy or hypersensitivity to MSCs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 (COVID-19) infection, some patients hospitalization to intensive care cause of pneumonia, Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure. Mortality is higher in treatment-resistant cases.
Purpose of this study:
Read more
- Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs,
- Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells,
- It is to accelerate healing in organ damage by increasing growth factors through mesenchymal stem cells.
Primary outcome: Improvement of clinical symptoms, reduction of cytokine storm Secondary outcome: Recovery of patients; from mechanical ventilation
Read the detailed description
Study design and participants This study was a single-center open-label, randomized trial conducted at an Education and Training Hospital, Istanbul from May to July, 2020, and it was performed according to the Declaration of Helsinki and approved by the Ethics Committee and health ministry (No:2020.05.20). Written informed consent was obtained from all patients or their representatives when data were collected prospectively.
Age, gender, mortality status, APACHE II score, number of days in ICU, procalcitonin and C-reactive protein values, leukocyte values, comorbid diseases, The cluster of differentiations 4 and 8 (CD4 and CD8), interleukin -2, interleukin -6, Tumor necrosis factor-alpha-beta levels will be recorded.
Clinical results, changes in inflammatory and immune function levels, and side effects will be recorded. The patient's lung function and symptoms will be recorded after Mesenchymal Stem Cell transplantation. After treatment, lymphocyte, C-reactive protein, Tumor Necrosis alpha-beta levels , interleukin-6 levels will be recorded.
Patients were divided into 3 groups:
- group: Intubated without comorbidity (n:7)
- group: Intubated with comorbidity (n:7)
- group: No intubated (n:7)
Dosage of Mesenchymal stem cells:
- 1 million cell/kg iv--------------------------------------------------day 0
- 1 million cell/kg iv -------------------------------------------------day 2
- 1 million cell/kg iv -------------------------------------------------day 4
- Being tested
- Mesenchymal stem cells
- Keywords
- Mesenchymal stem cells, COVID-19, Pneumonia
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsOther
Intravenous infusion of Mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Intubated without comorbidity Receives: Other: Mesenchymal stem cells |
| Group 2 | Active comparator | Intubated with comorbidity Receives: Other: Mesenchymal stem cells |
| Group 3 | Active comparator | No intubated Receives: Other: Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of clinical symptoms as respiratory distress or need for oxygen support
Recovery of patient from mechanical and oxygen support
Measured: 3 months
Change of cytokine storm parameters
respiratory rates < 30 times /min
Measured: 3 months
Change of pulmonary functions
Oxygen saturation > 93% and pulmonary imaging of focus within 24-48 hours > 50% progression
Measured: 3 months
Change of clinical symptoms
arterial pressure of oxygen/the fraction of inspired oxygen>300mmHg
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start8 May 2020
- Primary completion30 Jun 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Coronavirus Disease 2019 (COVID-19) patients with pneumonia 1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Sultan Sahin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Ebru Kaya, MD, Study chair, Kanuni Sultan Suleyman Education and Training HospitalGursel Turgut, Prof Dr, Study chair, GenkordAli Kocatas, MD, Study chair, Kanuni Sultan Suleyman Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713878
- Sponsor's protocol ID
- 2020.05.20
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04713878
- Acronym / sponsor ID
- 2020.05.20
- Keywords
- Mesenchymal stem cells, COVID-19, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 19 Jan 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.
Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 (COVID-19) infection, some patients hospitalization to intensive care cause of pneumonia, Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure. Mortality is higher in treatment-resistant cases.
Purpose of this study:
- Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs,
- Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells,
- It is to accelerate healing in organ damage by increasing growth factors through mesenchymal stem cells.
Primary outcome: Improvement of clinical symptoms, reduction of cytokine storm Secondary outcome: Recovery of patients; from mechanical ventilation
Detailed description
Study design and participants This study was a single-center open-label, randomized trial conducted at an Education and Training Hospital, Istanbul from May to July, 2020, and it was performed according to the Declaration of Helsinki and approved by the Ethics Committee and health ministry (No:2020.05.20). Written informed consent was obtained from all patients or their representatives when data were collected prospectively.
Age, gender, mortality status, APACHE II score, number of days in ICU, procalcitonin and C-reactive protein values, leukocyte values, comorbid diseases, The cluster of differentiations 4 and 8 (CD4 and CD8), interleukin -2, interleukin -6, Tumor necrosis factor-alpha-beta levels will be recorded.
Clinical results, changes in inflammatory and immune function levels, and side effects will be recorded. The patient's lung function and symptoms will be recorded after Mesenchymal Stem Cell transplantation. After treatment, lymphocyte, C-reactive protein, Tumor Necrosis alpha-beta levels , interleukin-6 levels will be recorded.
Patients were divided into 3 groups:
- group: Intubated without comorbidity (n:7)
- group: Intubated with comorbidity (n:7)
- group: No intubated (n:7)
Dosage of Mesenchymal stem cells:
- 1 million cell/kg iv--------------------------------------------------day 0
- 1 million cell/kg iv -------------------------------------------------day 2
- 1 million cell/kg iv -------------------------------------------------day 4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Coronavirus Disease 2019 (COVID-19) patients with pneumonia 1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Mesenchymal stem cellsIntubated without comorbidity |
| Group 2 | Active comparator | Other: Mesenchymal stem cellsIntubated with comorbidity |
| Group 3 | Active comparator | Other: Mesenchymal stem cellsNo intubated |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-90 male or female
- laboratory approve of RT-PCR (real-time reverse transcription polymerase chain reaction) with COVID-19 infection
- pneumonia assessed by chest radiography or computed tomography
- In accordance with any of the following: 1)Respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmHg, 4) pulmonary imaging of focus within 24-48 hours > 50% progression
- patients who remain unresponsive to medications administered according to Ministry of health guidelines
Key exclusion criteria (4 listed)
- Pregnancy
- Any kind of cancer, severe liver disease
- Failure to provide informed consent or comply with test requirements
- Known allergy or hypersensitivity to MSCs
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 cellsIntravenous infusion of Mesenchymal stem cells | Other | Group 1, Group 2, Group 3 |
Primary outcome
Change of clinical symptoms as respiratory distress or need for oxygen support
Time frame: 3 months
Recovery of patient from mechanical and oxygen support
Change of cytokine storm parameters
Time frame: 3 months
respiratory rates < 30 times /min
Change of pulmonary functions
Time frame: 3 months
Oxygen saturation > 93% and pulmonary imaging of focus within 24-48 hours > 50% progression
Change of clinical symptoms
Time frame: 3 months
arterial pressure of oxygen/the fraction of inspired oxygen>300mmHg
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 20 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Ebru Kaya, MD study chair
Kanuni Sultan Suleyman Education and Training Hospital
Gursel Turgut, Prof Dr study chair
Genkord
Ali Kocatas, MD study chair
Kanuni Sultan Suleyman Education and Training Hospital
1 site 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 in people with Coronavirus Disease 2019 (COVID-19) Pneumonia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site 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 6 inclusion and 4 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change of clinical symptoms as respiratory distress or need for oxygen support (time frame: 3 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 20 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.