Protocol summary
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Study aim
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The main objective is to investigate the safety of cell therapy in patients with ARDS caused by Coronavirus pneumonia
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Design
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A Phase 1 and 2, non-controlled non-randomized clinical trial
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Settings and conduct
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The study will be conducted at Masih Daneshvari Hospital and Shariati Hospital.
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Participants/Inclusion and exclusion criteria
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Patients aged 18 to 70 years are included in the study with a definitive diagnosis of COVID-19, which subsequently develops acute respiratory distress syndrome.
COVID-19 patients with severe underlying disease or allergies to the cell or its associated compounds are not included in the study.
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Intervention groups
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The intervention group (n=11) will receive three doses of MSCs. Three doses of 200×10e6± (10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
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Main outcome variables
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Side effects; oxygen saturation level; Improvement of clinical symptoms (fever, cough).
General information
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Reason for update
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The number of patients has increased.
Correction of inclusion and exclusion criteria.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200217046526N1
Registration date:
2020-04-13, 1399/01/25
Registration timing:
retrospective
Last update:
2020-06-10, 1399/03/21
Update count:
2
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Registration date
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2020-04-13, 1399/01/25
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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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2020-03-15, 1398/12/25
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Expected recruitment end date
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2020-03-25, 1399/01/06
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Actual recruitment start date
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2020-03-15, 1398/12/25
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Actual recruitment end date
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2020-03-25, 1399/01/06
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Trial completion date
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2020-04-25, 1399/02/06
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Scientific title
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Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection : A Phase 1 and 2 clinical trial
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Public title
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Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Informed consent
Male or female
18-70 years old
ARDS diagnosed
SOFA score between 2-13 point
Requiring mechanical ventilation and/or supplemental oxygen
Pneumonia that is judged by chest radiograph or CT scan or confirmation of SARS-CoV-2 infection by qRT-PCR
PaO2/oxygen absorption concentration (FiO2) ≤ 300 mmHG
Exclusion criteria:
Presenting severe allergies after 1st injection of stem cell
Patients with a malignant tumor and psychosis
Co-Infection of HIV, tuberculosis, adenovirus and another respiratory infection virus
Patients with previous history of pulmonary embolism
Moribund patient expecting death within 48 hours
Continuous use of immunosuppressive agents or organ transplants in the past 6 months
Pregnancy or breastfeeding
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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1-2
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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:
6
Actual sample size reached:
11
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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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2020-03-12, 1398/12/22
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Ethics committee reference number
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IR.NIMAD.REC.1398.412
Health conditions studied
1
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Description of health condition studied
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Acute Respiratory Distress Syndrome of 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
Primary outcomes
1
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Description
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Adverse events assesment
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Timepoint
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At the same time of each intervention, 24 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention
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Method of measurement
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcomes
1
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Description
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Blood oxygen saturation
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Timepoint
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At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention
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Method of measurement
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Evaluation of Pneumonia Improvement
Intervention groups
1
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Description
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Intervention group: (n=6). Patients will receive three doses of MSCs. Three doses of 200×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
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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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Iranian academic center for education culture and research
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Proportion provided by this source
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90
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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
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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National Institute for Medical Research Development
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Proportion provided by this source
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10
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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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Yes - There is a plan to make this available
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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
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Title and more details about the data/document
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All collected deidentified IPD can be shared
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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Researchers and clinicians
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Under which criteria data/document could be used
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Planning of similar studies in other academic centers
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From where data/document is obtainable
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Email
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What processes are involved for a request to access data/document
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1-2 months after request
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Comments
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