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Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients (UCMSC)

Primary Purpose

Covid 19

Status

Recruiting

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Normoxic Allogenic UCMSC

Normal saline solution

About this trial

This is an interventional treatment trial for Covid 19 focused on measuring COVID19, Mesenchymal Stem Cells (MCSs), Adjuvant therapy, Indonesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dr. Moewardi General HospitalRecruiting
Dr. Hasan SadikinRecruiting
Dr. Sardjito General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Control

Arm Description

Group receiving standard COVID-19 treatment and UCMSC infusion

Group receiving standard COVID-19 treatment and normal saline infusion

Outcomes

Primary Outcome Measures

Duration of hospital stay

Number of days since patient was administered until discharge in hospitals

Secondary Outcome Measures

Post-administration clinical and radiological improvement

Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale;

Adverse Event and Serious Adverse Event Evaluation

Evaluation of all adverse event or serious adverse event that is observed or reported by

Full Information

NCT ID

NCT05132972

First Posted

November 23, 2021

Last Updated

November 23, 2021

Sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05132972

Brief Title

Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2021 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid 19

Keywords

COVID19, Mesenchymal Stem Cells (MCSs), Adjuvant therapy, Indonesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Group receiving standard COVID-19 treatment and UCMSC infusion

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

Group receiving standard COVID-19 treatment and normal saline infusion

Intervention Type

Biological

Intervention Name(s)

Normoxic Allogenic UCMSC

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Normal saline solution

Intervention Description

Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)

Primary Outcome Measure Information:

Title

Duration of hospital stay

Description

Number of days since patient was administered until discharge in hospitals

Time Frame

20 - 24 days

Secondary Outcome Measure Information:

Title

Post-administration clinical and radiological improvement

Description

Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale;

Time Frame

Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day

Title

Adverse Event and Serious Adverse Event Evaluation

Description

Evaluation of all adverse event or serious adverse event that is observed or reported by

Time Frame

20 - 24 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bintang Soetjahjo, MD PhD

Phone

+628122987359

bjortho@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arief Nurudin, MD PhD

Organizational Affiliation

Dr. Moewardi General Hospital, Surakarta, Indonesia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Samekto Wibowo, Prof. MD

Organizational Affiliation

Dr. Sardjito General Hospital, Yogyakarta, Indonesia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ahmad Faried, Prof. MD

Organizational Affiliation

Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Moewardi General Hospital

City

Surakarta

State/Province

Central Java

ZIP/Postal Code

57126

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arief Nurudhin, MD, PhD

Phone

+6281393955596

First Name & Middle Initial & Last Name & Degree

Arief Nurudhin, MD, PhD

First Name & Middle Initial & Last Name & Degree

Bintang Soetjahjo, MD. PhD

First Name & Middle Initial & Last Name & Degree

Purwoko Purwoko, MD. PhD

First Name & Middle Initial & Last Name & Degree

Artrian Adhiputri, MD

First Name & Middle Initial & Last Name & Degree

Rina Sidharta, MD

First Name & Middle Initial & Last Name & Degree

Widiastuti Widiastuti, MD, PhD

Facility Name

Dr. Hasan Sadikin

City

Bandung

State/Province

West Java

ZIP/Postal Code

40161

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmad Faried, Prof. MD

Phone

+6281320230371

First Name & Middle Initial & Last Name & Degree

Ahmad Faried, Prof. MD

First Name & Middle Initial & Last Name & Degree

Rudi Wisaksana, MD. PhD

First Name & Middle Initial & Last Name & Degree

Arto Yuwono, MD. PhD

First Name & Middle Initial & Last Name & Degree

Tri Wahyu Murni, MD. PhD

First Name & Middle Initial & Last Name & Degree

Reza Sudjud, MD. PhD

Facility Name

Dr. Sardjito General Hospital

City

Yogyakarta

ZIP/Postal Code

55281

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samekto Wibowo, Prof. MD

Phone

+628122715617

First Name & Middle Initial & Last Name & Degree

Samekto Wibowo, Prof. MD

First Name & Middle Initial & Last Name & Degree

Sumardi Sumardi, MD

First Name & Middle Initial & Last Name & Degree

Sudadi Sudadi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jarir At Thobari, MD, PhD

First Name & Middle Initial & Last Name & Degree

E Henry Hamingtyas, MD, PhD

First Name & Middle Initial & Last Name & Degree

Rusdy Ghazali Malueka, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32214286

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.

Results Reference

result

PubMed Identifier

32281062

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/s11356-020-08439-3. Epub 2020 Apr 12.

Results Reference

result

PubMed Identifier

32756149

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.

Results Reference

result

PubMed Identifier

29859173

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.

Results Reference

result

PubMed Identifier

32085846

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. Erratum In: Lancet Respir Med. 2020 Feb 25;:

Results Reference

result

PubMed Identifier

32265310

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.

Results Reference

result

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Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

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