Clinical trial NCT05017298: Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Corona Virus Infection
Covid19
Lead sponsor: Celltex Therapeutics Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: Safety for AdMSCs based upon incidence of all AEs
timeFrame: 6 months
measure: Compare the mortality rate
timeFrame: 6 months
Secondary outcomes:
measure: Recognized immune measurements evaluating patients' symptom changes and overall function
timeFrame: 6 months
measure: Organ functional tests including blood specific enzymes and proteins
timeFrame: 6 months
measure: Duration (days) of weaning from mechanical ventilation
timeFrame: 6 months
measure: Duration (days) of ICU monitoring
timeFrame: 6 months
measure: Duration (days) of vasoactive agent's usage
timeFrame: 6 months
measure: Duration of hospitalization (days)
timeFrame: 6 months
measure: Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method
timeFrame: 6 months
measure: Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method
timeFrame: 6 months
measure: Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive
timeFrame: 6 months
Other outcomes:
measure: Mortality rate down to 0%
timeFrame: 6 months
measure: Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure
timeFrame: 6 months
Locations:
Study officials:
affiliation: Root Causes Medicine
name: Derek W Guillory, MD
role: PRINCIPAL_INVESTIGATOR
References: