Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients (UCMSC)

November 23, 2021 updated by: Bintang Soetjahjo, SpOT (K), MD. PhD, Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bintang Soetjahjo, MD PhD
  • Phone Number: +628122987359
  • Email: bjortho@yahoo.com

Study Locations

  • Indonesia
      • Yogyakarta, Indonesia, 55281
        • Recruiting
        • Dr. Sardjito General Hospital
        • Contact:
          • Samekto Wibowo, Prof. MD
          • Phone Number: +628122715617
        • Principal Investigator:
          • Samekto Wibowo, Prof. MD
        • Sub-Investigator:
          • Sumardi Sumardi, MD
        • Sub-Investigator:
          • Sudadi Sudadi, MD, PhD
        • Sub-Investigator:
          • Jarir At Thobari, MD, PhD
        • Sub-Investigator:
          • E Henry Hamingtyas, MD, PhD
        • Sub-Investigator:
          • Rusdy Ghazali Malueka, MD, PhD
    • Central Java
      • Surakarta, Central Java, Indonesia, 57126
        • Recruiting
        • Dr. Moewardi General Hospital
        • Contact:
          • Arief Nurudhin, MD, PhD
          • Phone Number: +6281393955596
        • Principal Investigator:
          • Arief Nurudhin, MD, PhD
        • Sub-Investigator:
          • Bintang Soetjahjo, MD. PhD
        • Sub-Investigator:
          • Purwoko Purwoko, MD. PhD
        • Sub-Investigator:
          • Artrian Adhiputri, MD
        • Sub-Investigator:
          • Rina Sidharta, MD
        • Sub-Investigator:
          • Widiastuti Widiastuti, MD, PhD
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Recruiting
        • Dr. Hasan Sadikin
        • Contact:
          • Ahmad Faried, Prof. MD
          • Phone Number: +6281320230371
        • Principal Investigator:
          • Ahmad Faried, Prof. MD
        • Sub-Investigator:
          • Rudi Wisaksana, MD. PhD
        • Sub-Investigator:
          • Arto Yuwono, MD. PhD
        • Sub-Investigator:
          • Tri Wahyu Murni, MD. PhD
        • Sub-Investigator:
          • Reza Sudjud, MD. PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Group receiving standard COVID-19 treatment and UCMSC infusion
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)
Sham Comparator: Control
Group receiving standard COVID-19 treatment and normal saline infusion
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: 20 - 24 days
Number of days since patient was administered until discharge in hospitals
20 - 24 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-administration clinical and radiological improvement
Time Frame: 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;
Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day
Adverse Event and Serious Adverse Event Evaluation
Time Frame: 20 - 24 days
Evaluation of all adverse event or serious adverse event that is observed or reported by
20 - 24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Collaborators

Dr. Moewardi General Hospital, Surakarta, Indonesia
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
PT Bifarma Adiluhung

Investigators

  • Principal Investigator: Arief Nurudin, MD PhD, Dr. Moewardi General Hospital, Surakarta, Indonesia
  • Principal Investigator: Samekto Wibowo, Prof. MD, Dr. Sardjito General Hospital, Yogyakarta, Indonesia
  • Principal Investigator: Ahmad Faried, Prof. MD, Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIN20211118a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid 19

Clinical Trials on Normoxic Allogenic UCMSC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe