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IRCT20190101042197N2 IRCT 2021-04-19 Danesh Bonyan Company: Tarmim Avaye Baran Umbilical cord exosomes for reducing inflammation in COVID-19 ARDS Randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of human umbilical cord MSC–derived exosomes (hUCMSC-Exos) in COVID-19–associated ARDS (Pilot study) 2021-05-20 anticipated 30 Complete https://irct.ir/trial/55380 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Single IV dose of hUCMSC-derived exosomes (5×10^10 particles in 2–5 mL PBS) + standard of care, Randomization description: Computer-generated sequence (SAS 9.1), stratified block, opaque sealed envelopes, allocation by independent blinded researcher, Blinding description: Double-blind (patients, investigators, outcome assessors). 1 Acute Respiratory Distress Syndrome due to COVID-19. Intervention 1: A total of 30 patients (15 in the intervention group and 15 in the control group) are randomly assigned in a 1:1 ratio. The intervention group receives a single intravenous dose of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) at 5×10¹⁰ particles in 2–5 mL PBS along with standard care. The control group receives a placebo (PBS of equal volume) along with standard care. Randomization is block-stratified, and the study is double-blind, so patients, investigators, and outcome assessors are unaware of group allocation. Intervention 2: Control group: Conventional treatments used in Acute Respiratory Distress Syndrome. Yes - There is a plan to make this available What will be shared: Some of the data can potentially be shared after de-identification of individuals. When: The access period will begin 6 months after the publication of the results. To whom: All people Conditions: Hospitals for clinical purposes and researchers for the accelerated advancement of projects. Where to obtain: Scientific responsibility for the clinical trial: Stem Cell and Regenerative Medicine Research Center, Iran University of Medical Sciences, Shahid Motahari Hospital. How to obtain: A written request specifying the reasons for the need for the data. Comments:
public Mehrdad Dargahi
Amaniyeh, Palestine Street, opposite the Governor’s Office, Razi Hospital
Ahvaz Iran (Islamic Republic of) 6196514941 +98 61 3333 3050 Dargahi-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Alireza Shoae Hassani
Valiasr, Rashid Yasemi St., Motahari Hospital, Stem Cell and Regenerative Medicine Research Center
Tehran Iran (Islamic Republic of) 1996835929 +98 21 8877 0031 cell.therapy@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 18 to 65 years Gender: Both PCR-confirmed COVID-19 moderate-to-severe ARDS (PaO2/FiO2 < 200) SpO2 < 93% on oxygen bilateral infiltrates on imaging written informed consent 18 years 65 years Both Malignancy pregnancy hepatic/renal failure lung or bone marrow transplant autoimmune/metabolic disease dialysis contagious infection active epilepsy coagulopathy J80 Acute respiratory distress syndrome Treatment - Other Placebo A total of 30 patients (15 in the intervention group and 15 in the control group) are randomly assigned in a 1:1 ratio. The intervention group receives a single intravenous dose of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) at 5×10¹⁰ particles in 2–5 mL PBS along with standard care. The control group receives a placebo (PBS of equal volume) along with standard care. Randomization is block-stratified, and the study is double-blind, so patients, investigators, and outcome assessors are unaware of group allocation. Control group: Conventional treatments used in Acute Respiratory Distress Syndrome Tumor necrosis factor alpha (TNF-α). Timepoint: Baseline to day 7. Method of measurement: It is measured in serum blood samples using an ELISA kit. CRP. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed in serum using an immunoassay kit. Serious Adverse Event (SAEs). Timepoint: Serious adverse events up to day 7. Method of measurement: Recorded from medical records and direct observation. IL-6. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed in serum using an ELISA kit. CD3+, CD4+, CD8+ lymphocytes. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed using a flow cytometry device. D-dimer. Timepoint: Changes from baseline to day 7. Method of measurement: Measurement is performed using the ELISA method. PRIEST score. Timepoint: Change up to day 7. Method of measurement: Assessment is performed by the treating physician according to standard guidelines. Chest imaging. Timepoint: Changes on day 3. Method of measurement: Assessment is performed using chest radiography and radiological interpretation. Length of hospital stay. Timepoint: Until discharge. Method of measurement: Recorded from the clinical file. Danesh Bonyan Company: Tarmim Avaye Baran Approved 2021-03-17 Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences Deputy of Research and Technology Development, Jundishapur University of Medical Sciences, Ahvaz, Ground Floor, Room 4 Ahvaz Khouzestan Iran (Islamic Republic of)