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Study aim:
Evaluation of using mesenchymal stem cells containing thymidine kinase gene in patients with glioblastoma multiforme.
Design:
A clinical trial with a control group, with parallel groups, randomized, phase 2 on 40 patients. The randomization function of Excel software was used for randomization.
Settings and conduct:
Forty patients with glioblastoma confirmed by two pathologists in this study will be randomly divided into control and gene therapy groups (twenty patients in each group). Patients will be screened every three months until the tumor recurs and dies. The study site will be Shohada 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: A total of 5 ^ 10 × 5 mesenchymal stem cells carrying with thymidine kinase gene are injected into the evacuated tumor site under the guidance of a brain navigation device. After cell injection, ganciclovir should be administered for a total of 28 doses over 14 days.
Control group: In this group, patients receive standard chemotherapy and radiotherapy.
Main outcome variables:
Overall survival; progression-free survival.