Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients ā¦ (NCT05501418) | Clinical Trial Compass
UnknownPhase 1/2
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With COVID-19
Taiwan75 participantsStarted 2020-08-05
Plain-language summary
This study is to explore the safety and efficacy of using UCMSC01 in patients with COVID-19 infection via IV stem cell administration. The novelty of the current UMSC01 treatment is the single IV infusion of UMSC01 to the worldwide emergency outbreaks of COVID-19. We hypothesize that sufficient UMSC01 retention in lung may modulate the systemic inflammatory responses.
Who can participate
Age range20 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Male or female aged 20 to 80 years old.
ā. Hospitalized severe and critical COVID-19 patients with laboratory confirmation by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal/ oropharyngeal samples collected using standardized method.
ā. Pneumonia or interstitial lung damage that is confirmed by chest radiographs or computed tomography.
ā. Severe COVID-19 infection which meets any one of the following: 1) dyspnea (PR ā„ 30 times/min), 2) finger oxygen saturation ā¤ 93% in the room air and resting state, 3) arterial oxygen partial pressure (PaO2)/oxygen absorption concentration (FiO2) ā¤ 300 mmHg, 4) pulmonary imaging which shows that the focus progress \> 50% within 24-48 hours, or
ā. Critically severe COVID-19 infection which meets any of the following: 1) respiratory failure treated by mechanical ventilation, 2) shock, 3) combined with other organ failure, 4) patients expected to need ICU monitoring and treatment.
ā. High sensitivity C-reactive protein (hs-CRP) serum level \> 4.0 mg/dL.
ā. All female patients with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) shown below, for at least 4 weeks after UMSC01 treatment and agree to maintain such contraceptive method(s) for another 4 weeks after UMSC01 treatment.
ā. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
. Pregnancy, lactation, and those who are not pregnant but did not, or unwilling to, take effective contraceptives measures 4 weeks before and after the treatment.
ā. Patients with malignant tumors or other serious systemic diseases.
ā. Presence of barotrauma or hemodynamic instability defined as hypotension with diastolic blood pressure \< 90 mmHg or mean arterial pressure (MAP) \< 70 mmHg despite fluid expansion, and vasoactive support or pneumothorax at screening.
ā. Uncontrolled hypertension with systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg which, in the investigator's judgment, would not make participation appropriate.
ā. Recent history of (within 2 years) ischemic heart disease or cerebrovascular attack, such as myocardial infarction, unstable angina, or stroke.
ā. Recent history (within 2 years) of hypercoagulable disorder, antiphospholipid syndrome, pulmonary embolism, or deep venous thrombosis.
ā. Condition other than COVID-19 that is projected to limit lifespan to ā¤ 1 year.