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| Name | Class |
|---|---|
| Dr. Moewardi General Hospital, Surakarta, Indonesia | OTHER |
| Dr. Sardjito General Hospital, Yogyakarta, Indonesia | UNKNOWN |
| Dr. Hasan Sadikin General Hospital, Bandung, Indonesia | UNKNOWN |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Group receiving standard COVID-19 treatment and UCMSC infusion |
|
| Control | Sham Comparator | Group receiving standard COVID-19 treatment and normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normoxic Allogenic UCMSC | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | Number of days since patient was administered until discharge in hospitals | 20 - 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-administration clinical and radiological improvement | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bintang Soetjahjo, MD PhD | Contact | +628122987359 | bjortho@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Arief Nurudin, MD PhD | Dr. Moewardi General Hospital, Surakarta, Indonesia | Principal Investigator |
| Samekto Wibowo, Prof. MD | Dr. Sardjito General Hospital, Yogyakarta, Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Moewardi General Hospital | Recruiting | Surakarta | Central Java | 57126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32214286 | Result | 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. | |
| 32281062 | Result | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| PT Bifarma Adiluhung | INDUSTRY |
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|
| Normal saline solution | Other | Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6) |
|
Evaluation of all adverse event or serious adverse event that is observed or reported by |
| 20 - 24 days |
| Ahmad Faried, Prof. MD | Dr. Hasan Sadikin General Hospital, Bandung, Indonesia | Principal Investigator |
| Dr. Hasan Sadikin | Recruiting | Bandung | West Java | 40161 | Indonesia |
|
| Dr. Sardjito General Hospital | Recruiting | Yogyakarta | 55281 | Indonesia |
|
| 32756149 | Result | 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. |
| 29859173 | Result | 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. |
| 32085846 | Result | 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. |
| 32265310 | Result | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |