Protocol summary
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Study aim
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Determination of Safety and Feasibility of Cell Therapy Using Mesenchymal stem Cells in Improving Patients with COVID-19
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Design
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one group with 5 uncontrolled patients, Phase I clinical trial
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Settings and conduct
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Intravenous injection of mesenchymal stem cells in Shariati hospital in Tehran
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Continuous hypoxemia, Respiratory failure requiring a Ventilator, Chest has multilobar infiltrates, Shock, Organ failure; Exclusion criteria: Patient dissatisfaction, Pregnant patient, Age less than 17 years, Patient with known active malignancy
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Intervention groups
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Mesenchymal stem cells about 2*106(based on IBW) MSC / Kg by intravenous injection three times in a patient
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Main outcome variables
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Evaluation of Survival rate patients after injection.
Laboratory Tests: Tests, Cell blood count albumin, ESR, D-dimer, LDH, CRP and
General information
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Reason for update
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Changes in initial outcomes, age limit, number of patients, and number of injections
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190717044241N2
Registration date:
2020-04-22, 1399/02/03
Registration timing:
registered_while_recruiting
Last update:
2020-09-14, 1399/06/24
Update count:
2
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Registration date
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2020-04-22, 1399/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-20, 1399/02/01
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Expected recruitment end date
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2020-10-21, 1399/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Cell therapy in patients with COVID-19 using mesenchymal stem cells
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Public title
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Cell therapy in patients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Persistent hypoxemia despite receiving less than 93% Saturation oxygen
Respiratory failure requires a Ventilator
Chest has multilobar infiltrates
Shock
Organ failure
Exclusion criteria:
Patient dissatisfaction
Pregnant patient
Age less than 17 years
Patient with known active malignancy
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Age
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From 17 years old to 65 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
5
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-13, 1399/01/25
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.203
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Clinical response
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Timepoint
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28 days-From the time of cell injection until the 28th day
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Method of measurement
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clinical observation by Infectious Diseases Specialist
2
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Description
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O2 saturation
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Timepoint
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0,3,6days.Since the injection of the cell
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Method of measurement
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ventilator
3
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Description
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inflammation cytokines. Il-6 & Il-10
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Timepoint
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0,3,6,14 days-Since the injection of the cell
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Method of measurement
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Assay by the Elisa
Intervention groups
1
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Description
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Intervention group: Patients with COVID-19 who are transplanted with mesenchymal stem cells that are injected 2x 106 (based on IBW) Via (IV) intravenous injection.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Barakat Pharmaceutical Group
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Proportion provided by this source
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80
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no additional data.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available