Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19; Corona Virus Infection
• Intervention / Treatment: Biological: Allogeneic adipose-derived stem cells

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jane Young, Ph.D.; Phone Number: 7135901000; Email: jyoung@celltexbank.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age above 18 years.
• Male and female
• Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
• Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive
• Clinical diagnosis meets severe and/or critical parameters
• Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity

Exclusion Criteria:

• Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
• Unwillingness or inability to comply with study procedures
• Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
• Clinically active malignant disease
• Subjects who are receiving ECMO and CRRT currently
• History of known pulmonary embolism or known secondary anti-phospholipid syndrome
• Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
• Known or suspected allergic to diphenhydramine.
• Major trauma or surgery within 14 days of study treatment start
• Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
• Alcohol, drug, or medication abuse within one year prior to study treatment start
• Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
• Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
• Patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
• History of long-term use of immunosuppressive agents
• Organ transplants in the past 6 months
• Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study.
• Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.
• QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.
• Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Each subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care.	Biological: Allogeneic adipose-derived stem cells; Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: Celltex-AdMSCs
Placebo Comparator: Control Group; The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care.	Biological: Allogeneic adipose-derived stem cells; Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue; Other Names: Celltex-AdMSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects.	Incidence of treatment-related adverse events and severe adverse events during the study period	6 months
Safety for AdMSCs based upon incidence of all AEs	Grouped by Medical Dictionary for Regulatory Activities (MedDRA)	6 months
Compare the mortality rate	AdMSC treating group vs. control group	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recognized immune measurements evaluating patients' symptom changes and overall function	To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline	6 months
Organ functional tests including blood specific enzymes and proteins	To evaluate the efficacy of allogeneic AdMSCs for COVID-19	6 months
Duration (days) of weaning from mechanical ventilation	Compared to control group	6 months
Duration (days) of ICU monitoring	Compared to control group	6 months
Duration (days) of vasoactive agent's usage	Compared to control group	6 months
Duration of hospitalization (days)	Compared to control group	6 months
Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method	Compared to control group	6 months
Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method	Compared to control group	6 months
Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive	Compared to control group	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate down to 0%	For severe and critical cases	6 months
Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure	Compared to control group	6 months

Collaborators and Investigators

• Sponsor: Celltex Therapeutics Corporation
• Investigators: Principal Investigator: Derek W Guillory, MD, Root Causes Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: CTX0020-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No