CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

autologous adipose-derived stem cellsWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1637 Non-interventional study Wiki 1.00

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D006402 Hematologic Diseases NIH 1.00
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001871 Abnormality of blood and blood-forming tissues HPO 1.00

There is one clinical trial.

Clinical Trials

1 Clinical Study for the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus 2019 (COVID-19)

This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells) intravenous infusion every three days. The 100 subjects in the control group who have previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but placebo treatments. All subjects are monitored for safety (adverse events/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6 months after the enrollment for the control group.

NCT04428801 COVID-19 Biological: autologous adipose-derived stem cells

Primary Outcomes

Description: adverse events and severe adverse events

Measure: Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication

Time: 6 months

Description: adverse events and severe adverse events

Measure: The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group

Time: 6 months

Description: efficacy

Measure: COVID-19 incidence rates in both the study and control groups

Time: 6 months

Secondary Outcomes

Description: efficacy

Measure: The proportion of subjects who are infected by SARS-Cov-2 measured by PCR or other nuclear level-based SARS-Cov-2 virus testing in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method.

Time: 6 months

Description: efficacy

Measure: The proportion of subjects who are infected by SARS-Cov-2 virus develop symptoms including mild, classic, severe and critical sever cases between study group and control group.

Time: 6 months

Description: efficacy

Measure: Change of proportion of subjects who are infected by SARS-Cov-2 and develop IgM/IgG antibodies against SARS-Cov-2 between study group and control group.

Time: 6 months

Description: efficacy

Measure: Change of lymphocyte count in white blood cell counts from the baseline

Time: 6 months

Description: efficacy

Measure: Change of PaO2 arterial blood gases from the baseline

Time: 6 months

Description: efficacy

Measure: Compare the proportion of subjects who develop severe COVID-19 pneumonia cases for both study and control groups

Time: 6 months

Description: efficacy

Measure: COVID-19 mortality rates for both study and control groups

Time: 6 months

Description: efficacy

Measure: Change of C-reactive protein (CRP) (mg/L) from the baseline

Time: 6 months

Description: efficacy

Measure: Change of D-dimer (mg/L) from the baseline

Time: 6 months

Description: efficacy

Measure: Change of Procalcitonin (ug)/L from the baseline

Time: 6 months

Description: efficacy

Measure: Change of pro-type B natriuretic peptide (pro-BNP) (pg/mL) from the baseline

Time: 6 months

Description: efficacy

Measure: Change of Bilirubin (mg/dL) from the baseline

Time: 6 months

Description: efficacy

Measure: Change of Creatinine (mg/dL) from the baseline

Time: 6 months

Description: efficacy

Measure: Change in blood test values for cytokine panels (IL-1β, IL-6, IL-8, IL-10, TNFα) from the baseline

Time: 6 months

Description: efficacy

Measure: The proportion of subjects from SARS-CoV-2 RT-PCR positive to negativity in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method. as compared to control group

Time: 6 months

Description: efficacy

Measure: Quantifying viral RNA in stool for baseline and final follow-up.

Time: 6 months

No related HPO nodes (Using clinical trials)