NCT05132972

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

November 23, 2021

Last Update Submit

November 23, 2021

Conditions

Covid 19

Keywords

COVID19Mesenchymal Stem Cells (MCSs)Adjuvant therapyIndonesia

Outcome Measures

Primary Outcomes (1)

  • Duration of hospital stay

    Number of days since patient was administered until discharge in hospitals

    20 - 24 days

Secondary Outcomes (2)

  • Post-administration clinical and radiological improvement

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

  • Adverse Event and Serious Adverse Event Evaluation

    20 - 24 days

Study Arms (2)

Treatment

EXPERIMENTAL

Group receiving standard COVID-19 treatment and UCMSC infusion

Biological: Normoxic Allogenic UCMSC

Control

SHAM COMPARATOR

Group receiving standard COVID-19 treatment and normal saline infusion

Other: Normal saline solution

Interventions

Normoxic Allogenic UCMSCBIOLOGICAL

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)

Treatment
Normal saline solutionOTHER

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

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dr. Moewardi General Hospital

Surakarta, Central Java, 57126, Indonesia

RECRUITING

Dr. Hasan Sadikin

Bandung, West Java, 40161, Indonesia

RECRUITING

Dr. Sardjito General Hospital

Yogyakarta, 55281, Indonesia

RECRUITING

Related 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.

    PMID: 32214286RESULT

  • 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.

    PMID: 32281062RESULT

  • 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.

    PMID: 32756149RESULT

  • 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.

    PMID: 29859173RESULT

  • 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.

    PMID: 32085846RESULT

  • 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.

    PMID: 32265310RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bintang Soetjahjo, MD PhD

CONTACT

+628122987359bjortho@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

November 23, 2021

First Posted

November 24, 2021

Study Start

January 17, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

ID(3)