clinical study for subjects with covid-19 using allogeneic adipose tissue-derived mesenchymal stem cells

Conditions: Corona Virus Infection; Covid19

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.