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Trial record 2 of 114 for:    mesenchymal | covid

Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05122234
Recruitment Status : Completed
First Posted : November 16, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Murdani abdullah, Indonesia University

Brief Summary:
This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Injection of secretome - mesenchymal stem cell Other: Placebo Drug: Standard treatment of Covid-19 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
Actual Study Start Date : August 10, 2020
Actual Primary Completion Date : July 30, 2021
Actual Study Completion Date : November 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Secretome - mesenchymal stem cell group (n = 20)
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
Biological: Injection of secretome - mesenchymal stem cell
Secretome will be given once at a dose of 15 ml per administration dissolved in 100 ml of normal saline. The administration is done intravenously for 60 minutes.

Drug: Standard treatment of Covid-19
Standard treatment of Covid-19 based on national protocol.

Placebo Comparator: Control ( n= 20)
This group will be given placebo and COVID-19 standard therapy
Other: Placebo
Normal saline

Drug: Standard treatment of Covid-19
Standard treatment of Covid-19 based on national protocol.




Primary Outcome Measures :
  1. Assessment of inflamation marker levels [ Time Frame: Day 0 (before intervention), day 7, day 14 ]
    The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.


Secondary Outcome Measures :
  1. Assessment of clinical outcome [ Time Frame: before and after intervention (maximum 14 days after intervention) ]
    Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.

  2. Assessment of laboratory routine [ Time Frame: before and after intervention (maximum 14 days after intervention) ]
    Laboratory routine assessed in this study is NLR, lymphocyte count, thrombocytes count, CRP, blood gas analysis, bilirubin, albumin, SGOT, SGPT, ureum/creatinin, glomerular filtration rate (GFR), electrolyte, myoglobin, troponin, D-dimer.

  3. Assessment of photo thorax [ Time Frame: before and after intervention (maximum 14 days after intervention) ]
    Photo thorax will assess before and after intervention

  4. Assessment of RT-PCR conversion [ Time Frame: before and after intervention (maximum 14 days after intervention) ]
    RT-PCR conversion will assess before and after intervention

  5. Mortality rate [ Time Frame: maximum 14 days after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All individuals aged 18 to 65 years
  2. It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
  3. Categorized as a severe case of COVID-19 patient
  4. Agree to participate and sign the informed consent

Exclusion Criteria:

  1. History of allergy to penicillin, streptomycin, and amphotericin-B
  2. Have any cancer conditions
  3. Active in other intervention studies
  4. Have had other intervention studies in the last 3 months

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): NCT05122234


Locations
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Indonesia
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia
RSUP Fatmawati
Jakarta, DKI Jakarta, Indonesia
RSUP Persahabatan
Jakarta, DKI Jakarta, Indonesia
Rumah Sakit Universitas Indonesia
Depok, Jawa Barat, Indonesia
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia
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Responsible Party: Murdani abdullah, Prof. M.D., PhD, FACG, FASGE, Indonesia University
ClinicalTrials.gov Identifier: NCT05122234    
Other Study ID Numbers: 54/FI/P-KCOVID-19.2B3/IX/2020
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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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 Murdani abdullah, Indonesia University:
Severe Covid-19
secretome
mesenchymal stem cell
cytokine
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