AdMSCs: Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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. [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 [6 months]
Grouped by Medical Dictionary for Regulatory Activities (MedDRA)
- Compare the mortality rate [6 months]
AdMSC treating group vs. control group
Secondary Outcome Measures
- Recognized immune measurements evaluating patients' symptom changes and overall function [6 months]
To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline
- Organ functional tests including blood specific enzymes and proteins [6 months]
To evaluate the efficacy of allogeneic AdMSCs for COVID-19
- Duration (days) of weaning from mechanical ventilation [6 months]
Compared to control group
- Duration (days) of ICU monitoring [6 months]
Compared to control group
- Duration (days) of vasoactive agent's usage [6 months]
Compared to control group
- Duration of hospitalization (days) [6 months]
Compared to control group
- Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method [6 months]
Compared to control group
- Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method [6 months]
Compared to control group
- Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive [6 months]
Compared to control group
Other Outcome Measures
- Mortality rate down to 0% [6 months]
For severe and critical cases
- Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure [6 months]
Compared to control group
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age above 18 years.
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Male and female
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Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
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Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive
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Clinical diagnosis meets severe and/or critical parameters
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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:
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Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
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Unwillingness or inability to comply with study procedures
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Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
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Clinically active malignant disease
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Subjects who are receiving ECMO and CRRT currently
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History of known pulmonary embolism or known secondary anti-phospholipid syndrome
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Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
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Known or suspected allergic to diphenhydramine.
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Major trauma or surgery within 14 days of study treatment start
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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
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Alcohol, drug, or medication abuse within one year prior to study treatment start
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Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
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Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
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Patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
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History of long-term use of immunosuppressive agents
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Organ transplants in the past 6 months
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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.
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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.
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QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.
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Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Celltex Therapeutics Corporation
Investigators
- Principal Investigator: Derek W Guillory, MD, Root Causes Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTX0020-004