]>
IRCT20200510047385N1 IRCT 2020-07-07 Tabriz University of Medical Sciences Effects of SVF and exosome in covid-19 patients with acute respiratory distress syndrome تاثیرقطعه عروقی استروما و اگزوزوم دربیماران کووید 19مبتلا به سندرم دیسترس تنفسی حاد Effect of stromal vascular fraction (SVF), blood and condition medium derived exosomes on treatment of covid-19 patients with Acute Respiratory Distress Syndrome(ARDS)/ clinical Trial 2020-06-30 anticipated 60 Complete https://irct.ir/trial/48099 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: Due to the fact that the approved kit for Svf separation will be used it is processed non-enzymatically and for a maximum of 2 hours and will be autologous and we will not have cell culture and will be done in the operating room, all the rules related to GCP, GMP will be considered, Blinding description: Participants are leading researchers, especially in trials initiated by academic researchers, health care personnel (physicians, nurses, etc.) who are responsible for patient care, data collection authorities and those Assessing the outcome will be blind. The Data Safety and Monitoring Committee will not be blind. To receive blood samples from patients, the relevant code of ethics will be obtained from the Ethics Committee of Tabriz University of Medical Sciences. In addition, patients will be given informed consent to participate in the study. This study has no cost for patients and patients can leave the study at any time. All patient information will be confidential. 2-3 Covid19. Intervention group: Patients are divided into four control and experimental groups (60 patients: 15 patients in each group). Routine control group with routine treatment Receiver group SVF autologous group Blood exosome group Autologous group exposed to SVF autologous fluid It should be noted that all groups receive the same common treatments. Yes - There is a plan to make this available What will be shared: All data will be published in the form of an article When: 2 year To whom: All Conditions: Awareness and no conditions Where to obtain: Article or email How to obtain: email Comments:
public leila Roshangar
no 31 bagshomal Ave, Banafshe
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 3870 lroshangar@yahoo.com Tabriz University of Medical Sciences scientific leila Roshangar
31 no bagshomal Ave- banafshe
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 3870 lroshangar@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) covid19 patients hospitalized in the ICU, which includes all confirmatory tests – Satisfaction in studying 15 years 70 years Both History of kidney transplantation History surgery on the lungs The presence of any malignancy Previous active infection Use immunosuppressive and other drugs The presence of autoimmune disease Treatment - Other Intervention group: Patients are divided into four control and experimental groups (60 patients: 15 patients in each group). Routine control group with routine treatment Receiver group SVF autologous group Blood exosome group Autologous group exposed to SVF autologous fluid It should be noted that all groups receive the same common treatments Evaluation of inflammatory status IL1,. Timepoint: per 3 days. Method of measurement: Eliza. Tabriz University of Medical Sciences Approved 2020-07-01 دانشEthics committee of tabriz University of Medical Sciencesگاه no7, baghshomal ave, banafshe, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)