Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells

Официальное название

Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

Обзор

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.

Вмешательства

• Биопрепарат Allogeneic adipose-derived stem cells
  Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Первичные конечные точки

• 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. [Срок оценки: 6 months]
• Safety for AdMSCs based upon incidence of all AEs [Срок оценки: 6 months]
• Compare the mortality rate [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Recognized immune measurements evaluating patients' symptom changes and overall function [Срок оценки: 6 months]
• Organ functional tests including blood specific enzymes and proteins [Срок оценки: 6 months]
• Duration (days) of weaning from mechanical ventilation [Срок оценки: 6 months]
• Duration (days) of ICU monitoring [Срок оценки: 6 months]
• Duration (days) of vasoactive agent's usage [Срок оценки: 6 months]
• Duration of hospitalization (days) [Срок оценки: 6 months]
• Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method [Срок оценки: 6 months]
• Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method [Срок оценки: 6 months]
• Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05017298 · CTX0020-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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