Clinical trial NCT05132972: Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid 19
Keywords: COVID19
Mesenchymal Stem Cells (MCSs)
Adjuvant therapy
Indonesia
Lead sponsor: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Sponsor class: OTHER_GOV
Collaborators: name: Dr. Moewardi General Hospital, Surakarta, Indonesia
name: Dr. Sardjito General Hospital, Yogyakarta, Indonesia
name: Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
name: PT Bifarma Adiluhung
First posted: 2021-11-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Duration of hospital stay
timeFrame: 20 - 24 days
Secondary outcomes:
measure: Post-administration clinical and radiological improvement
timeFrame: Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day
measure: Adverse Event and Serious Adverse Event Evaluation
timeFrame: 20 - 24 days
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Dr. Moewardi General Hospital
state: Central Java
city: Bandung
country: Indonesia
facility: Dr. Hasan Sadikin
state: West Java
city: Yogyakarta
country: Indonesia
facility: Dr. Sardjito General Hospital
Study officials:
affiliation: Dr. Moewardi General Hospital, Surakarta, Indonesia
name: Arief Nurudin, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Sardjito General Hospital, Yogyakarta, Indonesia
name: Samekto Wibowo, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
name: Ahmad Faried, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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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 (Baltimore). 2020 Jul 31;99(31):e21429. doi: 10.1097/MD.0000000000021429.
citation: 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.
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(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
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):2000858. doi: 10.1183/13993003.00858-2020. Print 2020 Jun.