COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05017298

Jane Young, Ph.D.

jyoung@celltexbank.com

2021-08-23

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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

- 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.

2

Celltex Therapeutics Corporation

18

100

None

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

30

Compare the mortality rate;Safety for AdMSCs based upon incidence of all AEs;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.

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 60, "treatment_name": "Allogeneic adipose-derived mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]