This study is conducted to assess the efficacy and safety of stem cells as adjunctivetreatment for severe COVID-19 patients. Here, we want to study whether the administrationof mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms
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
Biological: Normoxic Allogenic UCMSC
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)
Other: Normal saline solution
Sterile saline solution and adminastered through intravenous infusion three times, at
three day intervals (day 0, day 3, and day 6)
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
Dr. Moewardi General Hospital
Surakarta, Central Java, Indonesia
Dr. Hasan Sadikin
Bandung, West Java, Indonesia
Dr. Sardjito General Hospital
Yogyakarta, Indonesia
Bintang Soetjahjo, MD PhD
+628122987359
bjortho@yahoo.com