NCT05240430

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 27, 2022

Last Update Submit

February 13, 2022

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

COVID-19SARS-CoV-2Mesenchymal Stem CellIntensive Care Units

Outcome Measures

Primary Outcomes (5)

  • Change in acute phase reactants (C-reactive protein (CRP) after MSC administration in group I, II, III

    It was aimed to observe the changes in C-reactive protein (CRP), after MSC administration at different times (groups 1,2,3).

    MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after

  • Change in acute phase reactants (procalcitonin) after MSC administration in group I, II, III

    It was aimed to observe the changes in procalcitonin after MSC administration at different times (groups 1,2,3).

    MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after

  • Change in acute phase reactants ( white blood cell count) after MSC administration in group I, II, III

    It was aimed to observe the changes in white blood cell count after MSC administration at different times (groups 1,2,3).

    MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after

  • Changes in respiratory support after MSC administration in Groups I, II, III

    It was aimed to observe the changes in respiratory support (such as high-flow nasal oxygen, mask with reservoir, and mechanical ventilation) after MSC administration at different times (groups 1,2,3).

    MSC treatment Group I disease 0-7. days, Group II; 8-14 days of the disease. days, Group III; Those applied on the 15th day and after

  • Changes in arterial blood gas analysis (partial oxygen/fractionated oxygen (Pa/Fi) ratio) after MSC administration in Groups I, II, III

    It was aimed to observe the changes in arterial blood gas analysis after MSC administration in Groups I, II, III.

    MSC treatment before (day 0) and after MSC application, on 3rd and 7th days,

Secondary Outcomes (1)

  • Effect on mortality after MSC administration in Groups I, II, III

    7, 14 and 28 days after MSC application

Study Arms (3)

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,

Drug: Mesenchymal Stem Cell Antigen-1, Human

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

Drug: Mesenchymal Stem Cell Antigen-1, Human

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.

Drug: Mesenchymal Stem Cell Antigen-1, Human

Interventions

Mesenchymal Stem Cell Antigen-1, HumanDRUG

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

Also known as: Human umblical cord deriveted Mesenchymal Stem Cell
stem cell application; Group I disease 0-7. days,stem cell application; Group II; 8-14 days of the disease. daysstem cell application; Group III; those applied on the 15th day and after.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID PCR positive * Those who received MSC treatment * Those with advanced respiratory failure * Those who have progressed despite the standard recommended (antiviral, steroid, anticoagulant and vitamin) supportive treatment

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences

Trabzon, Yomra, 61500, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

W8B2 protein, human

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ahmet AKYOL, MD

    Trabzon Kanuni Training and Research Hospital, University of Healthy Sciences, Trabzon, Turkey

    STUDY CHAIR

Central Study Contacts

Recep ERİN, MD

CONTACT

+90462 341 5656erinrecep@gmail.com

Seyfi KARTAL, MD

CONTACT

+904623415656drseyfikartal@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 15, 2022

Study Start

January 1, 2022

Primary Completion

February 28, 2022

Study Completion

March 31, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No personal data belonging to the participants were used.

Locations

TU(1)