Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients
NCT ID: NCT05132972
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2021-01-17
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Group receiving standard COVID-19 treatment and UCMSC infusion
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)
Control
Group receiving standard COVID-19 treatment and normal saline infusion
Normal saline solution
Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)
Interventions
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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)
Normal saline solution
Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Dr. Moewardi General Hospital, Surakarta, Indonesia
OTHER
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
UNKNOWN
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
UNKNOWN
PT Bifarma Adiluhung
INDUSTRY
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
OTHER_GOV
Responsible Party
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Bintang Soetjahjo, SpOT (K), MD. PhD
Coordinating Investigator
Principal Investigators
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Arief Nurudin, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. Moewardi General Hospital, Surakarta, Indonesia
Samekto Wibowo, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Ahmad Faried, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
Locations
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Dr. Moewardi General Hospital
Surakarta, Central Java, Indonesia
Dr. Hasan Sadikin
Bandung, West Java, Indonesia
Dr. Sardjito General Hospital
Yogyakarta, , Indonesia
Countries
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Central Contacts
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Facility Contacts
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Arief Nurudhin, MD, PhD
Role: primary
Ahmad Faried, Prof. MD
Role: primary
Samekto Wibowo, Prof. MD
Role: primary
References
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Atluri S, Manchikanti L, Hirsch JA. Expanded Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) as a Therapeutic Strategy in Managing Critically Ill COVID-19 Patients: The Case for Compassionate Use. Pain Physician. 2020 Mar;23(2):E71-E83.
Richardson JB. Urban forests near municipal solid waste incinerators do not show elevated trace metal or rare earth element concentrations across three cities in the northeast USA. Environ Sci Pollut Res Int. 2020 Jun;27(17):21790-21803. doi: 10.1007/s11356-020-08439-3. Epub 2020 Apr 12.
Liang B, Chen J, Li T, Wu H, Yang W, Li Y, Li J, Yu C, Nie F, Ma Z, Yang M, Xiao M, Nie P, Gao Y, Qian C, Hu M. Clinical remission of a critically ill COVID-19 patient treated by human umbilical cord mesenchymal stem cells: A case report. Medicine (Baltimore). 2020 Jul 31;99(31):e21429. doi: 10.1097/MD.0000000000021429.
Galipeau J, Sensebe L. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities. Cell Stem Cell. 2018 Jun 1;22(6):824-833. doi: 10.1016/j.stem.2018.05.004.
Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
Khoury M, Cuenca J, Cruz FF, Figueroa FE, Rocco PRM, Weiss DJ. Current status of cell-based therapies for respiratory virus infections: applicability to COVID-19. Eur Respir J. 2020 Jun 4;55(6):2000858. doi: 10.1183/13993003.00858-2020. Print 2020 Jun.
Other Identifiers
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BRIN20211118a
Identifier Type: -
Identifier Source: org_study_id