When to Apply to Which Patient in MSC?

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Mesenchymal stem cell (MSC) therapy is among the promising treatments for acute respiratory distress syndrome (ARDS). Our study aimed to investigate the clinical efficacy of MSC treatment in COVID-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to prognosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

NCT04525378

Covid19 ARDS, Human

UNKNOWN PHASE1

Clinical Use of Stem Cells for the Treatment of Covid-19

NCT04392778

Covid19 Pneumonia Multiple Organ Failure +1 more

COMPLETED PHASE1/PHASE2

Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)

NCT04377334

ARDS COVID-19

UNKNOWN PHASE2

Use of UC-MSCs for COVID-19 Patients

NCT04355728

Corona Virus Infection ARDS ARDS, Human +2 more

COMPLETED PHASE1/PHASE2

Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19

NCT04416139

Covid 19

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study was conducted retrospectively in patients diagnosis of COVID-19 in the intensive care units. Patients with severe ARDS \[partial pressure of arterial blood oxygen and inhaled oxygen fraction (PaO2: FiO2) ratio of 100 or less\] were included in the study. Demographic data of the patients (gender, age), comorbidities (hypertension, coronary heart disease, diabetes, cerebrovascular diseases, hepatitis B infection, cancer, chronic kidney disease, and immunodeficiency), Charlson comorbidity index (CMI), date of diagnosis, date of admission to the hospital, date of admission to the ICU, Acute Physiology And Chronic Health Evaluation (APACHE) II score, presence of high flow nasal oxygen (HFNO) or mechanical ventilator (MV) support, laboratory findings (blood cell count, blood biochemistry, hepatorenal function, coagulation function, D-dimer, C-reactive protein (CRP), procalcitonin, ferritin, arterial blood gas analysis) before (day 0) and after MSC application, on 3rd and 7th days, partial oxygen/fractionated oxygen (Pa/Fi) ratio, discharge or death information, and attributed causes of death were recorded on the study form. Pa/Fi ratio was calculated with the formula (oxygen dissolved in arterial blood gas / oxygen liter given to the patient).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Acute Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stem cell application; Group I disease 0-7. days,

In mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group I disease 0-7. days,

Mesenchymal Stem Cell Antigen-1, Human

Intervention Type DRUG

Human umbilical cord-derived MSCs were used in the study. MSCs were prepared/obtained/produced/provided by Atigen-Cell Technology Center, Trabzon, Turkey. MSC for patients was calculated as a single dose, 1x106 cells per kilogram. MSC was infused in 100 ml of normal saline at 2 ml/min over 40 min, as described in previous studies

stem cell application; Group II; 8-14 days of the disease. days

In mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group II; 8-14 days of the disease. days

Mesenchymal Stem Cell Antigen-1, Human

Intervention Type DRUG

Human umbilical cord-derived MSCs were used in the study. MSCs were prepared/obtained/produced/provided by Atigen-Cell Technology Center, Trabzon, Turkey. MSC for patients was calculated as a single dose, 1x106 cells per kilogram. MSC was infused in 100 ml of normal saline at 2 ml/min over 40 min, as described in previous studies

stem cell application; Group III; those applied on the 15th day and after.

In mesenchymal stem cell application, according to the diagnosis of COVID 19 and the day of stem cell application; Group III; It will be divided into 3 groups as those applied on the 15th day and after.

Mesenchymal Stem Cell Antigen-1, Human

Intervention Type DRUG

Human umbilical cord-derived MSCs were used in the study. MSCs were prepared/obtained/produced/provided by Atigen-Cell Technology Center, Trabzon, Turkey. MSC for patients was calculated as a single dose, 1x106 cells per kilogram. MSC was infused in 100 ml of normal saline at 2 ml/min over 40 min, as described in previous studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mesenchymal Stem Cell Antigen-1, Human

Human umbilical cord-derived MSCs were used in the study. MSCs were prepared/obtained/produced/provided by Atigen-Cell Technology Center, Trabzon, Turkey. MSC for patients was calculated as a single dose, 1x106 cells per kilogram. MSC was infused in 100 ml of normal saline at 2 ml/min over 40 min, as described in previous studies

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Human umblical cord deriveted Mesenchymal Stem Cell

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who were followed up and treated after being admitted to the Intensive Care Unit after March 2020
* Patients with COVID PCR +
* Typical or suspected cases of Thorax BT COVID
* Cases over the age of 18.

Exclusion Criteria

* Those with a contraindicated condition (cancer disease, allergy) for MSC application
* Those who are endotracheal intubated during the application and are connected to a respirator
* Those who died in the first 24 hours after the application
* Cases that are not positive or suspicious for COVID.
* Cases under the age of 18.
* Cases where patient data could not be reached.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No