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IRCT20170122032121N6 IRCT 2021-11-19 Royan institute NK cell therapy in pediatrics with brain glioma Evaluation of the safety of intrathecal injection of activated allogenic Natural Killer (NK) cells in pediatrics with brain gliomas; A phase I clinical trial 2021-10-17 anticipated 10 Complete https://irct.ir/trial/59715 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Brain glioma. Intervention group: 40-50 million activated allogenic NK cells will be injected intrathecally every week till five injection. In cases of response to the treatment, five more injections will be planned.. Yes - There is a plan to make this available What will be shared: After concealment of personal information of participants, data of eligibility, CRFs and measured outcomes can be shared in case of request. When: After publishing results in a scientific journal with no deadline To whom: Just to academic PIs Conditions: Any usage of data should be consulted and approved by the PIs (Dr.Ebrahimi and Dr.Faranoush) Where to obtain: Applicant should send an e-mail to Dr.Mahdizadeh and propose their detailed requirements of the study data How to obtain: After sending an e-mail to Dr.Mahdizadeh, he will assess the authenticity of the applicant in almost 2 weeks. Then he will plan a meeting (visual or attendance) for the applicant with Dr.Ebrahimi and Dr.Faranoush in next month. The applicant can obtain approval of data sharing in this meeting and the data will be sent in next 14 days. Comments:
public Hamid Mahdizadeh
Kian immune cell company, first floor, Royan RITAC center, Number 6, Keshvari alley, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1665651911 009823562000 mahdizadehmd@yahoo.com Royan institute scientific Hamid Mahdizadeh
Kian immune cell company, first floor, Royan RITAC center, Number 6, Keshvari alley, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1665651911 009823562000 mahdizadehmd@yahoo.com Royan institute Iran (Islamic Republic of) patients with diagnosis of brain stem glioma, DIPG, unresectable glioma, and relapsed-refractory glioma Age between 3 to 18 years old Hemoglobin level above 10 gr/deciliter of blood Absolute granulocyte count (AGC) above 1500 per microliter of blood Platelet count above 100000 per microliter of blood Lansky (for under 16 years old) or Karnofsky (for above 16 years old) performance score above 60 INR below 2 and PTT less than 1/5 times of maximum normal value Plasma Bilirubin level less than 1/5 times of maximum normal value Plasma hepatic transaminases (ALT and AST) level less than 2/5 times of maximum normal value Plasma Creatinine level less than 1/5 times of maximum normal value Informed consent of parents or legal attendance 3 years 18 years Both evidence of radio necrosis in MRI or MRS intolerance of new treatment due to emergency condition rupture of cerebral shunt or unable to perform a lumbar puncture (LP) history of other malignancies history of any immunodeficiency diseases or any immune compromising conditions occurrence of new neurologic lesion after first injection C71 Malignant neoplasm of brain Treatment - Other Intervention group: 40-50 million activated allogenic NK cells will be injected intrathecally every week till five injection. In cases of response to the treatment, five more injections will be planned. Safety of intrathecal injection of Natural Killer (NK) cells. Timepoint: safety will be measured after each injection till 24 hour in hospital for acute adverse events. Other adverse events will be recorded in periodical follow up in 1, 3, 6, and 12 month after the last injection. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAEs) checklist. Change of tumor size. Timepoint: Tumor size will be measured before the first injection and after fifth and tenth injection it will be measured again. 3 month, 6 month and 12 month after the last injection the size will be measured ordinally. Method of measurement: MRI (with and without contrast and DWI method) and MRS. Overall survival and progression-free survival. Timepoint: At the end of the study the survivals will be measured for patients. Method of measurement: Kaplan-Meier method. Cerebrospinal fluid (CSF) analysis (cytokine changes, hematology, and biochemistry). Timepoint: Before each injection, samples of CSF will be taken and will sent to lab for analysis. Method of measurement: ELISA, Spectrophotometry, microscopic study. Kian Immune Cell company Royan institute Kian Immune Cell company Approved 2021-09-21 Royan institute ethics committee Royan ethics committee, Royan alley, Hafez street, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)