A Phase 2/3 interventional study of Normoxic Allogenic UCMSC and Normal saline solution in Covid 19, sponsored by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia. Status unknown at 3 sites in Indonesia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia · Phase 2/3, Interventional, and Treatment
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 42 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group receiving standard COVID-19 treatment and UCMSC infusion
Biological: Normoxic Allogenic UCMSC
Group receiving standard COVID-19 treatment and normal saline infusion
Other: Normal saline solution
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)
Duration 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
Plan to share: No
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia