NCT05017298Not yet recruitingPhase 2
Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Study Group
Experimental
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.
Intervention: Allogeneic adipose-derived stem cells (Biological)
Control Group
Placebo Comparator
The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care.
Intervention: Allogeneic adipose-derived stem cells (Biological)
Outcomes
Primary Outcomes
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.
Time Frame: 6 months
Incidence of treatment-related adverse events and severe adverse events during the study period
Safety for AdMSCs based upon incidence of all AEs
Time Frame: 6 months
Grouped by Medical Dictionary for Regulatory Activities (MedDRA)
Compare the mortality rate
Time Frame: 6 months
AdMSC treating group vs. control group
Secondary Outcomes
- Recognized immune measurements evaluating patients' symptom changes and overall function(6 months)
- Duration (days) of ICU monitoring(6 months)
- Duration of hospitalization (days)(6 months)
- Duration (days) of vasoactive agent's usage(6 months)
- Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method(6 months)
- Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive(6 months)
- Organ functional tests including blood specific enzymes and proteins(6 months)
- Duration (days) of weaning from mechanical ventilation(6 months)
- Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method(6 months)
Investigators
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