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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
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)
Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)
Dr. Moewardi General Hospital
Surakarta, Central Java, Indonesia
RECRUITINGDr. Hasan Sadikin
Bandung, West Java, Indonesia
RECRUITINGDr. Sardjito General Hospital
Yogyakarta, Indonesia
RECRUITINGDuration of hospital stay
Number of days since patient was administered until discharge in hospitals
Time frame: 20 - 24 days
Post-administration clinical and radiological improvement
Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale;
Time frame: 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
Time frame: 20 - 24 days
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