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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.