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.
Biological: Allogeneic adipose-derived stem cells
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Other Name: Celltex-AdMSCs
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.
Jane Young, Ph.D.
7135901000
jyoung@celltexbank.com
Derek W Guillory, MD, Principal Investigator
Root Causes Medicine