Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia (CELMA)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Umbilical cord derived mesenchymal stem cells
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Mesenchymal Stem Cells, Umbilical Cord
Eligibility Criteria
Inclusion Criteria:
- Severe COVID-19.
- Infection confirmed by PCR test.
- Hospitalized in general room (respiratory isolation area).
Exclusion Criteria:
- Shock or multiorgan disfunction that require continous vital signs monitorization
- Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
- Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
- Pregnant women or breast feeding.
- Advanced hearth failure.
- VIH/AIDS.
- Bacterial or fungical uncontroled infection.
- Permanente use of immunosupresants or have had received an organ trasnplanted in the past six months.
- Imposibility to sign the informent consent format.
- Patients involved in another clinical trial with drugs or interventions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control
Arm Description
Usual tratment for COVID-19 plus MSC
Usual treatment for COVID-19
Outcomes
Primary Outcome Measures
Clinical deterioration or death
Change in two or more degrees in the NEWS scale
Secondary Outcome Measures
Full Information
NCT ID
NCT04429763
First Posted
June 10, 2020
Last Updated
June 10, 2020
Sponsor
Trustem
Collaborators
Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose, Hospital Infantil Universitario de San Jose
1. Study Identification
Unique Protocol Identification Number
NCT04429763
Brief Title
Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia
Acronym
CELMA
Official Title
Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trustem
Collaborators
Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose, Hospital Infantil Universitario de San Jose
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world.
There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people.
It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.
Detailed Description
Objetive:
Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the clinical progresion and mortality of hospitalized COVID-19 patients.
Metodology:
Fase II, controled clinical trial, double blinded, compared with placebo, with paralel groups, and one to one asignation. It will be included patients between 18 and 79 years old, hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis. It will be excluded those who have indication for management in Intensive Care Unit, have any condition that seriusly affect their survival, pregnant whomen or breast feeding, those who have an advanced hearth failure, HIV infected, those who have a bacterial or fungal uncontroled infection, those who require permanent immunosupresive therapy or have had an organ trasplant, those who have no possibility to sign the informed consent format or are involved in another clinical trial with drugs or interventions.
It will vinculate 30 patients randomly assigned, by centralized electronic assignation sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human umbilical cord or to placebo group.
The primary result it will be a composed point of time to the occurrence of the clinical detriment or the death (the first that occurs) and the secondary result will be the components of each primary point, the clinical recovery, the time to the time to the discharge from the hospital, and the clinical follow-up, including respiratory function, and markers of inflammation, haematological and kidney, in addition of the safety markers.
It will be done a comparison of the incidence rates, by ratio of incidence rates and their respective confidence interval. It will be construct Kaplan-Meier curves that will compared by the statics of logaritmic rank (log-rank test).
It will be developed a multivariate analysis, with the Cox proportional risks methodology, estimating the Hazard Ratio epidemiologic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Mesenchymal Stem Cells, Umbilical Cord
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
It will be included 30 patients, randomly assigned by centralized electronic sequence of assignation, for the application of a single dosis of 1*10^6 cells/Kg or placebo
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Usual tratment for COVID-19 plus MSC
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual treatment for COVID-19
Intervention Type
Biological
Intervention Name(s)
Umbilical cord derived mesenchymal stem cells
Intervention Description
One dosis of 1*10^6 cells/Kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Clinical deterioration or death
Description
Change in two or more degrees in the NEWS scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe COVID-19.
Infection confirmed by PCR test.
Hospitalized in general room (respiratory isolation area).
Exclusion Criteria:
Shock or multiorgan disfunction that require continous vital signs monitorization
Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
Pregnant women or breast feeding.
Advanced hearth failure.
VIH/AIDS.
Bacterial or fungical uncontroled infection.
Permanente use of immunosupresants or have had received an organ trasnplanted in the past six months.
Imposibility to sign the informent consent format.
Patients involved in another clinical trial with drugs or interventions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jhon Jaime Sprockel Díaz, MD, Esp
Phone
+573538000
Email
jjsprockel@fucsalud.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Araque, MD, Esp
Phone
+574377540
Email
caroaraque@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Sánchez-Vanegas, MD, PhD
Organizational Affiliation
Fundación Universitaria de Ciencias de la Salud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Escobar-Soto, MD, PhD
Organizational Affiliation
Trustem
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia
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