Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05132972

Collaborator

Dr. Moewardi General Hospital, Surakarta, Indonesia (Other), Dr. Sardjito General Hospital, Yogyakarta, Indonesia (Other), Dr. Hasan Sadikin General Hospital, Bandung, Indonesia (Other), PT Bifarma Adiluhung (Industry)

Enrollment

Locations

Arms

9.5

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid 19	Biological: Normoxic Allogenic UCMSC Other: Normal saline solution	Phase 2/Phase 3

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 17, 2021

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group receiving standard COVID-19 treatment and UCMSC infusion	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)
Sham Comparator: Control Group receiving standard COVID-19 treatment and normal saline infusion	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)

Arm

Intervention/Treatment

Experimental: Treatment

Group receiving standard COVID-19 treatment and UCMSC infusion

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)

Sham Comparator: Control

Group receiving standard COVID-19 treatment and normal saline infusion

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)

Outcome Measures

Primary Outcome Measures

Duration of hospital stay [20 - 24 days]
Number of days since patient was administered until discharge in hospitals

Secondary Outcome Measures

Post-administration clinical and radiological improvement [Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day]
Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale;
Adverse Event and Serious Adverse Event Evaluation [20 - 24 days]
Evaluation of all adverse event or serious adverse event that is observed or reported by

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Moewardi General Hospital	Surakarta	Central Java	Indonesia	57126
2	Dr. Hasan Sadikin	Bandung	West Java	Indonesia	40161
3	Dr. Sardjito General Hospital	Yogyakarta		Indonesia	55281

Sponsors and Collaborators

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

Investigators

Principal Investigator: Arief Nurudin, MD PhD, Dr. Moewardi General Hospital, Surakarta, Indonesia
Principal Investigator: Samekto Wibowo, Prof. MD, Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Principal Investigator: Ahmad Faried, Prof. MD, Dr. Hasan Sadikin General Hospital, Bandung, Indonesia