Protocol summary
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Study aim
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Evaluation of safety and feasibility of using allogeneic/autologous mesenchymal stem cells containing lentivirus carrying thymidine kinase gene in patients with glioblastoma multiforme.
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Design
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Uncontrolled phase 1 clinical trial in 5 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Overall survival; progression-free survival.
General information
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Reason for update
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Given the ease of availability, isolation, and preparation process as well as less associated morbidity for patients, allogeneic cell source was also added to the study. This change was made in the study title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200502047277N2
Registration date:
2020-10-08, 1399/07/17
Registration timing:
retrospective
Last update:
2022-11-05, 1401/08/14
Update count:
1
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Registration date
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2020-10-08, 1399/07/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-11, 1396/09/20
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Expected recruitment end date
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2020-09-05, 1399/06/15
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Actual recruitment start date
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2018-02-04, 1396/11/15
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Actual recruitment end date
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2020-09-05, 1399/06/15
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Trial completion date
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2020-09-05, 1399/06/15
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Scientific title
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Intracerebral Administration of Allogeneic/Autologous Mesenchymal Stem Cells as HSV-TK Gene Vehicle for Treatment of Glioblastoma: Safety and Feasibility Assessment
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Public title
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Evaluation of the safety and feasibility of stem cell-mediated gene therapy in the treatment of glioblastoma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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.
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Age
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No age limit
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Gender
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Both
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
8
Actual sample size reached:
5
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-06-07, 1396/03/17
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Ethics committee reference number
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IR.SBMU.REC.1396.224
Health conditions studied
1
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Description of health condition studied
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Glioma grade 4
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ICD-10 code
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C71
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ICD-10 code description
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Malignant neoplasm of brain
Primary outcomes
1
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Description
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Overall survival (OS) of patients
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Timepoint
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Before treatment and every three months until the patient's death
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Method of measurement
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The time from treatment initiation until patient's death
2
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Description
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Radiological progression free survival (PFS) of patients
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Timepoint
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Before treatment and every three months until the disease recurrence
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Method of measurement
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The time from treatment initiation until disease progression or worsening
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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through email request
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When the data will become available and for how long
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12 month
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To whom data/document is available
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Principal investigator of other clinical trials
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Under which criteria data/document could be used
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official request
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From where data/document is obtainable
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direct request to email
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What processes are involved for a request to access data/document
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evaluation of the validity of the applicant
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Comments
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