Clinical Use of Stem Cells for the Treatment of Covid-19
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|ClinicalTrials.gov Identifier: NCT04392778|
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : May 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Pneumonia Multiple Organ Failure Corona Virus Infection||Biological: MSC Treatment Biological: Saline Control||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||What is the Effect of Mesenchymal Stem Cell Therapy on Seriously Ill Patients With Covid 19 in Intensive Care? (Prospective Double Controlled Study)|
|Actual Study Start Date :||April 1, 2020|
|Actual Primary Completion Date :||November 1, 2020|
|Actual Study Completion Date :||November 30, 2020|
No Intervention: Untreated
Group 1: patients that are not on a ventilator (n=10) No extra intervention will be done.
Sham Comparator: Saline Control
Group 2: patients that are on a ventilator and will receive saline injections (n=10) as control for MSC transplantation group (3).
Biological: Saline Control
Saline will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.
Experimental: Experimental UC-MSCs
Group 3: patients that are on a ventilator and will receive MSC transplantation injections (n=10)
Biological: MSC Treatment
Protocol length: 1 week
will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.
- Clinical improvement [ Time Frame: 3 months ]Improvement of clinical symptoms related to Covid-19 infection (fever, pneumonia, shortness of breath)
- Lung damage improvement [ Time Frame: 3 months ]Improvement of lungs assessed by CT Scan
- Sars-Cov-2 viral infection laboratory test [ Time Frame: 3 months ]Negative, measured by RT-PCR laboratory tests for the virus
- Blood test [ Time Frame: 3 months ]Cell types and numbers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392778
|Istanbul, Turkey, 34010|
|SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi|
|Istanbul, Turkey, 34147|
|Principal Investigator:||Gokhan T Adas, Prof.Dr.||SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi|
|Principal Investigator:||Erdal Karaoz, Prof.Dr.||Istinye University|