Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Phase 2

• Conditions: Covid 19
• Interventions: Biological: Normoxic Allogenic UCMSC; Other: Normal saline solution

• Registration Number: NCT05132972
• Lead Sponsor: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Brief 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

Study Timeline

• Study Start: 2021-01-17
• Status Verified: 2021-11
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Normoxic Allogenic UCMSC	Group receiving standard COVID-19 treatment and UCMSC infusion
Control	Normal saline solution	Group receiving standard COVID-19 treatment and normal saline infusion

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	20 - 24 days	Number of days since patient was administered until discharge in hospitals

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Dr. Moewardi General Hospital; 🇮🇩 Surakarta, Central Java, Indonesia

Dr. Hasan Sadikin; 🇮🇩 Bandung, West Java, Indonesia

Dr. Sardjito General Hospital; 🇮🇩 Yogyakarta, Indonesia