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IRCT20200502047277N2 IRCT 2020-10-08 Shahid Beheshti University of Medical Sciences Evaluation of the safety and feasibility of stem cell-mediated gene therapy in the treatment of glioblastoma Intracerebral Administration of Allogeneic/Autologous Mesenchymal Stem Cells as HSV-TK Gene Vehicle for Treatment of Glioblastoma: Safety and Feasibility Assessment 2017-12-11 anticipated 8 Complete https://irct.ir/trial/48110 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Glioma grade 4. Intervention group: This group undergoes gene therapy along with standard treatment (chemotherapy and radiotherapy). Then 5×10^5 mesenchymal stem cells infected with lentivirus carrying the Thymidine Kinase gene are injected into the tumor site through stereotactic injection. After cell injection, the Ganciclovir drug administration continues for a total of 28 doses over 14 days.. 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 further information
public Saeed Oraee Yazdani
Shohadaye Tajrish Hospital, Tajrish Ave.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 saeed_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Masoud Soleimani
Tarbiat Modares University, Jalal AleAhmad Highway
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4508 soleim_m@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Karnofsky performance status> 70. Adequate hematological function (an absolute neutrophil count > 1500/μl and platelet count > 125000/mm3). Adequate renal function (creatinine < 1.5 times the normal). Adequate hepatic function (aspartate aminotransferase and bilirubin < 1.5 times the normal). Patient who fill informed consent. no limit no limit Both Significant vascular disease. History of recurrent thromboembolism. Prior history of hypertensive crisis or hypertensive encephalopathy. Gastrointestinal fistula or perforation. History of intraabdominal or intracranial abscess within 6 months. Serious non healing wound, ulcer and bone fracture. C71 Malignant neoplasm of brain Treatment - Other Intervention group: This group undergoes gene therapy along with standard treatment (chemotherapy and radiotherapy). Then 5×10^5 mesenchymal stem cells infected with lentivirus carrying the Thymidine Kinase gene are injected into the tumor site through stereotactic injection. After cell injection, the Ganciclovir drug administration continues for a total of 28 doses over 14 days. Overall survival (OS) of patients. Timepoint: Before treatment and every three months until the patient's death. Method of measurement: The time from treatment initiation until patient's death. Radiological progression free survival (PFS) of patients. Timepoint: Before treatment and every three months until the disease recurrence. Method of measurement: The time from treatment initiation until disease progression or worsening. Shahid Beheshti University of Medical Sciences Approved 2017-06-07 Ethics committee of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie 7th Floor, Building Number. 2, Shahid Beheshti University of Medical Sciences, Arabi Avenue, Daneshjoo Boulevard, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)