NCT05132972

Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Covid 19

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-01-17
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2021-11-24
• Last updated: 2021-11-24

Locations

3 sites across 1 country: Indonesia