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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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200502047277N2
Enrollment
8
Registered
2020-10-08
Start date
2017-12-11
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma grade 4. Malignant neoplasm of brain

Interventions

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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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). Patient who fill informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Oraee Yazdani

Shahid Beheshti University of Medical Sciences

saeed_o_yazdani@yahoo.com+98 21 25719

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026