Evaluation of Safety and Efficacy of Human UmbilicalCord Derived Mesenchymal Stem Cells (MSCs) inPatients with Moderate to Severe SARS-CoV-2 Infection(SpO2 Ã¢â?°Â¤94% and Respiratory Rate Ã¢â?°Â¥24 per minute): AnAdaptive, Seamless Phase-1/Phase-2, Prospective,Open-labelled, Multi-center Study

ifeCell International Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1 A positive reverse transcription, polymerase chain reaction (RT-PCR) assay for SARS-CoV-2.
•2 Patients currently hospitalized with moderate to severe SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus) infection (COVID19) satisfying the criteria as below:
•a. Peripheral capillary oxygen saturation (SpO2) Ã¢â?°Â¤94%.
•b. Respiratory rate Ã¢â?°Â¥24 breaths per minute with/without breathlessness.
•3 Lower respiratory tract infection at screening suggestive of moderate to severe COVID19 disease: radiographic infiltrates on X-ray chest (PA view) or chest spiral CT scan.
•4 Patients with onset of COVID19 symptoms within 5 days prior to screening.
•5 Willing and able to provide written informed consent prior to performing any study related procedure.

•1 Patients with mild COVID19 disease (SpO2 >94%, and/or respiratory rate <24 breaths per minute.
•2 High risk individuals:
•a Age > 60 years
•b Known patients of any cardiovascular disease, hypertension, and CAD
•c Known patients of type-1 or type-2 diabetes mellitus
•d Any immunocompromised states
•e History of chronic lung/kidney/liver disease
•f History of any cerebrovascular disease
•3 Participation in any other clinical trial of an experimental treatment for COVID-19.
•4 Evidence of multiorgan failure.
•5 Mechanically ventilated (including V-V ECMO or V-A ECMO).
•6 Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN).
•7 Creatinine clearance <30 mL/min using the Cockcroft-Gault formula.
•8 Pregnant or breast-feeding women.
•9 Anticipated discharge from the hospital or transfer to another hospital within 72 hours of enrolment.
•10 Hypersensitivity to active ingredient(s) or any of the excipients of the study formulation.
•11 Patient who declines to sign the written informed consent.
•12 Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol.

发起方

ifeCell International Pvt Ltd