Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Covid 19 Clinical Trial

— UCMSC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132972
• Other study ID #: BRIN20211118a
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 17, 2021
• Est. completion date: November 2021

Study information

• Verified date: November 2021
• Source: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
• Contact: Bintang Soetjahjo, MD PhD
• Phone: +628122987359
• Email: bjortho[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid 19
• COVID-19

Intervention

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)

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)

Locations

Country	Name	City	State
Indonesia	Dr. Hasan Sadikin	Bandung	West Java
Indonesia	Dr. Moewardi General Hospital	Surakarta	Central Java
Indonesia	Dr. Sardjito General Hospital	Yogyakarta

Sponsors (5)

Lead Sponsor	Collaborator
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia	Dr. Hasan Sadikin General Hospital, Bandung, Indonesia, Dr. Moewardi General Hospital, Surakarta, Indonesia, Dr. Sardjito General Hospital, Yogyakarta, Indonesia, PT Bifarma Adiluhung

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

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. — View Citation

Galipeau J, Sensébé 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. Review. — View Citation

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). pii: 2000858. doi: 10.1183/13993003.00858-2020. Print 2020 J — View Citation

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 (Baltim — View Citation

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/s113 — View Citation

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospital stay	Number of days since patient was administered until discharge in hospitals	20 - 24 days
Secondary	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
Secondary	Adverse Event and Serious Adverse Event Evaluation	Evaluation of all adverse event or serious adverse event that is observed or reported by	20 - 24 days