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IRCT20170122032121N5 IRCT 2020-06-11 Iranian academic center for education culture and research Nk cell therapy for recurrent GBM (Glioblastoma Multiform) : The Safety Evaluation of Ex vivo Activated Haploidentical Natural Killer Cells (NK) in patients with Recurrent Glioblastoma Multiform and resistant/recurrent malignant brain tumor (Clinical Trial Phase I) 2020-07-10 anticipated 5 Complete https://irct.ir/trial/47366 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Recurrent Glioblastoma Multiform(GBM) and resistant/recurrent malignant brain tumor. Intervention group: 5 patients with recurrent glioblastoma and resistant/recurrent malignant brain tumor are included in the study according to the inclusion criteria. The peripheral blood of one parent is obtained with his/her consent. Then the NK cells are isolated and activated by the cliniMACS device. Microbial tests and cell quality control are performed. 7 days after surgery, MRI is ordered then, two million cells per 0.5 cc (cell count is variable depend on tumor size) are injected into the tumor cavity or CSF removed by surgery via a reservare which fixes in the patient's cranium. This injection is given again in the second and third weeks after the surgery with an increasing trend in the number of cells and before the start of radiotherapy. With the diagnosis of the physician, the number of injections can be increased.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Niloufar Shayan Asl
Royan Institute ,Royan alley, Banihashem square, Resalat highway, Tehran.
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2521 niloufar.shayanasl@gmail.com Iranian academic center for education culture and research scientific Dr.Marzieh Ebrahimi
Royan Institute ,Royan alley, Banihashem square, Resalat highway, Tehran.
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2516 marzieh.ebrahimi@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Age: 3-65 Year Sex: Both Lansky/Karnofsky performance statue: 7-100% Life span expectation: >6 months Hemoglobin: > 10.0 g/dL AGC > 1,500/mm³ Platelet count > 100,000/mm³ Serum total bilirubin < 1.5 times upper limit of normal(ULN) ALT and AST < 2.5 times ULN Serum creatinine < 1.5 times ULN 3 years 65 years Both Patients whose MRI or MRS view of the brain is in favor of radio necrosis Due to emergency conditions, the patient can not tolerate the new treatment Insufficient number of NK cells produced for treatment appearance new neurological ulcers after the first injection (after the wound heals, subsequent injections will be given if the patient is in good condition) diagnosis of any other invasive cancer within the past 5 years. Closing the reservare for the next injection (if this problem is solved, the injections will be done again. concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study C71.9 Malignant neoplasm of brain, unspecified Treatment - Other Intervention group: 5 patients with recurrent glioblastoma and resistant/recurrent malignant brain tumor are included in the study according to the inclusion criteria. The peripheral blood of one parent is obtained with his/her consent. Then the NK cells are isolated and activated by the cliniMACS device. Microbial tests and cell quality control are performed. 7 days after surgery, MRI is ordered then, two million cells per 0.5 cc (cell count is variable depend on tumor size) are injected into the tumor cavity or CSF removed by surgery via a reservare which fixes in the patient's cranium. This injection is given again in the second and third weeks after the surgery with an increasing trend in the number of cells and before the start of radiotherapy. With the diagnosis of the physician, the number of injections can be increased. Fever. Timepoint: After cell injection, every 2 hours up to 48 hours after cell injection. Method of measurement: Fever meter. Hysteria. Timepoint: After cell injection, control the symptom up to 48 hours. Method of measurement: Patient checkup. New neurological symptoms which not related to the tumor. Timepoint: Up to 48 hours after surgery, up to one week after cell injection. Method of measurement: Physical examination and recording of symptoms. Tumor size. Timepoint: One week after injection, every 2 weeks up to 3 months. Method of measurement: MRI and MRS. Patient's survival. Timepoint: Every month up to 6 months. Method of measurement: Communicate with patients. Parsian Lotus Investment Bank Iranian academic center for education culture and research Parsian Lotus Investment Bank Approved 2020-02-29 Ethics committee of the Royan Institute ٌRoyan institute, Royan alley, Banihashem street, Resalat highway Tehran Tehran Iran (Islamic Republic of) Approved 2021-02-17 Ethics committee of the Royan Institute ٌRoyan institute, Royan alley, Banihashem street, Resalat highway Tehran Tehran Iran (Islamic Republic of)