Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Last updated: November 23, 2021
Sponsor: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Overall Status: Active - Recruiting

Phase

2/3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05132972
BRIN20211118a
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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, cougwith 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

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

Total Participants: 42
Study Start date:
January 17, 2021
Estimated Completion Date:
November 30, 2021

Study 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

Connect with a study center

  • Dr. Moewardi General Hospital

    Surakarta, Central Java 57126
    Indonesia

    Active - Recruiting

  • Dr. Hasan Sadikin

    Bandung, West Java 40161
    Indonesia

    Active - Recruiting

  • Dr. Sardjito General Hospital

    Yogyakarta, 55281
    Indonesia

    Active - Recruiting

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