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

Covid19 Clinical Trial

— AdMSCs  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05017298
• Other study ID #: CTX0020-004
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2024
• Est. completion date: November 15, 2026

Study information

• Verified date: April 2023
• Source: Celltex Therapeutics Corporation
• Contact: Jane Young, Ph.D.
• Phone: 7135901000
• Email: jyoung[@]celltexbank.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 15, 2026
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19

Intervention

Biological:
• Allogeneic adipose-derived stem cells
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Celltex Therapeutics Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality rate down to 0%	For severe and critical cases	6 months
Other	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
Primary	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
Primary	Safety for AdMSCs based upon incidence of all AEs	Grouped by Medical Dictionary for Regulatory Activities (MedDRA)	6 months
Primary	Compare the mortality rate	AdMSC treating group vs. control group	6 months
Secondary	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
Secondary	Organ functional tests including blood specific enzymes and proteins	To evaluate the efficacy of allogeneic AdMSCs for COVID-19	6 months
Secondary	Duration (days) of weaning from mechanical ventilation	Compared to control group	6 months
Secondary	Duration (days) of ICU monitoring	Compared to control group	6 months
Secondary	Duration (days) of vasoactive agent's usage	Compared to control group	6 months
Secondary	Duration of hospitalization (days)	Compared to control group	6 months
Secondary	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
Secondary	Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method	Compared to control group	6 months
Secondary	Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive	Compared to control group	6 months