Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Study Overview
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Brief Summary
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This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms

Detailed Description
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This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion

Official Title
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Efficacy and Safety of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered as Adjuntive Treatment to Standard Treatment in Severe Patients With COVID-19

Conditions
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Covid 19

Intervention / Treatment
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* Biological: Normoxic Allogenic UCMSC
* Other: Normal saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman age 18-75 years SARS-CoV2 positive as confirmed by SARS-CoV2 RT-PCR Test Diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: RR > 30x per minute, SaO2 93%, FaO2/FiO2 300 mmHg Voluntarily joined the clinical trial and has signed the informed consent form Exclusion Criteria: Pregnant and lactating woman Patient who are diagnosed or have history of tumor and cancer Patient whose mother or sister are diagnosed with breast or ovarian cancer Level of SGPT/ALT is ≥ 5 times upper limit from normal value Level of eGFR is < 30 ml/min Reluctant to sign informed consent and unwilling to take the required tests Require invasive ventilation Shock Organ failure Currently involve in other clinical trial, or join another clinical trial in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Group receiving standard COVID-19 treatment and UCMSC infusion | Biological: Normoxic Allogenic UCMSC<br>* Allogenic umbilical cord-derived mesenchymal stem cell (UCMSC) from normoxic, culture condition, administered through intravenousinfusion at dose 1x10^6 cells MSC/kg body weight. The treatment will be administered three times, at three days intervals (day 0, day 3, and day 6)<br>|
| Sham Comparator: Control<br>Group receiving standard COVID-19 treatment and normal saline infusion | Other: Normal saline solution<br>* Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | Number of days since patient was administered until discharge in hospitals | 20 - 24 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-administration clinical and radiological improvement | Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale; | Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day | 
| Adverse Event and Serious Adverse Event Evaluation | Evaluation of all adverse event or serious adverse event that is observed or reported by | 20 - 24 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Mesenchymal Stem Cells (MCSs), Adjuvant therapy, Indonesia