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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05132972
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborators:
Dr. Moewardi General Hospital, Surakarta, Indonesia
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
PT Bifarma Adiluhung
Information provided by (Responsible Party):
Bintang Soetjahjo, SpOT (K), MD. PhD, Dr. Moewardi General Hospital, Surakarta, Indonesia

Study Description
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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

Condition or disease Intervention/treatment Phase
Covid 19 Biological: Normoxic Allogenic UCMSC Other: Normal saline solution Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered as Adjuntive Treatment to Standard Treatment in Severe Patients With COVID-19
Actual Study Start Date : January 17, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: 20 - 24 days ]
    Number of days since patient was administered until discharge in hospitals


Secondary Outcome Measures :
  1. 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;

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05132972


Contacts
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Contact: Bintang Soetjahjo, MD PhD +628122987359 bjortho@yahoo.com

Locations
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Indonesia
Dr. Moewardi General Hospital Recruiting
Surakarta, Central Java, Indonesia, 57126
Contact: Arief Nurudhin, MD, PhD    +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         
Dr. Hasan Sadikin Recruiting
Bandung, West Java, Indonesia, 40161
Contact: Ahmad Faried, Prof. MD    +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         
Dr. Sardjito General Hospital Recruiting
Yogyakarta, Indonesia, 55281
Contact: Samekto Wibowo, Prof. MD    +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         
Sponsors and Collaborators
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Dr. Moewardi General Hospital, Surakarta, Indonesia
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
PT Bifarma Adiluhung
Investigators
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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
More Information
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Publications of Results:

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Responsible Party: Bintang Soetjahjo, SpOT (K), MD. PhD, Coordinating Investigator, Dr. Moewardi General Hospital, Surakarta, Indonesia
ClinicalTrials.gov Identifier: NCT05132972    
Other Study ID Numbers: BRIN20211118a
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bintang Soetjahjo, SpOT (K), MD. PhD, Dr. Moewardi General Hospital, Surakarta, Indonesia:
COVID19
Mesenchymal Stem Cells (MCSs)
Adjuvant therapy
Indonesia
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases