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IRCT20190717044241N1 IRCT 2020-02-15 Tehran University of Medical Sciences Infusion of human-derived placental-derived mesenchymal stem cells in patients with acute liver failure P-MSCs Cell therapy using human-derived placental-derived mesenchymal stem cells in patients with Acute liver failure: clinical trial phase I 2019-12-22 anticipated 5 Complete https://irct.ir/trial/40909 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Acute liver failure. Intervention group: Patients with acute liver failure who are transplanted with placenta-derived mesenchymal stem cells that are injected 1–1.5 x 106 Via (IV) intravenous injection.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No information provided
public Mahshid Saleh
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
Tehran Iran (Islamic Republic of) 55469-14177 +98 21 4305 2000 Mahshid_saleh@ymail.com Tehran University of Medical Sciences scientific Dr Javad Verdi - Dr Mehdi Mohammadnejad
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
Tehran Iran (Islamic Republic of) 55469-14177 +98 21 4305 2000 javadverdi2019@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) ALF: The occurrence of hepatic encephalopathy is less than 8 weeks after the onset of jaundice in a disease that does not have a history of known liver disease. All patients with ALF or ACLF are admitted to hospital at Shariati Hospital and Imam Khomeini Hospital. 17 years no limit Both Patient dissatisfaction Pregnant patient Age less than 17 years Patient with known active malignancy Treatment - Other Intervention group: Patients with acute liver failure who are transplanted with placenta-derived mesenchymal stem cells that are injected 1–1.5 x 106 Via (IV) intravenous injection. Type and amount of observed side effects due to placental mesenchymal stem cells in patients with Acute Liver Failure in order to safety assessment for this intervention. Timepoint: At 24, 48, 72 hours and one month post cell transplantation. Method of measurement: General physical assessments and laboratory tests like blood, serum, and urine analysis. Severity of clinical scores,Consciousness Test. Timepoint: At 24, 48, 72 hours and one month post cell transplantation. Method of measurement: clinical observation by Gastroenterologist. Assessment of Liver function. Timepoint: At 24, 48, 72 hours and one month post cell transplantation. Method of measurement: PT,INR,ALT,AST,CBC. Tehran University of Medical Sciences Approved 2019-12-25 Iran National committee for Ethics in Biomedical research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)