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Study aim: Evaluation of safety and feasibility of using allogeneic/autologous mesenchymal stem cells containing lentivirus carrying thymidine kinase gene in patients with glioblastoma multiforme. Design: Uncontrolled phase 1 clinical trial in 5 patients. Settings and conduct: Five patients with glioblastoma confirmed by two pathologists will be examined in this study. This study does not have a control group and randomization. Patients will be examined every three months until tumor recurrence and death. The study site will be Shohadaye Tajrish Hospital. Participants/Inclusion and exclusion criteria: Inclusion criteria: 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). Patients who fill informed consent. Exclusion criteria: Significant vascular disease. History of recurrent thromboembolism. Prior history of hypertensive crisis or hypertensive encephalopathy. Gastrointestinal fistula or perforation. History of an intraabdominal or intracranial abscess within 6 months. Serious non-healing wound, ulcer and bone fracture. Intervention groups: 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 using stereotactic injection. After cell injection, the Ganciclovir drug administration continues for a total of 28 doses over 14 days. Main outcome variables: Overall survival; progression-free survival.
IRCTID: IRCT20200502047277N2
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