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NOT YET RECRUITING
NCT04428801
PHASE2

Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19

Sponsor: Celltex Therapeutics Corporation

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-09

Completion Date

2026-09

Last Updated

2023-04-18

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

autologous adipose-derived stem cells

Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue