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IRCT20160419027479N2 IRCT 2018-02-14 VC for Research and Technology and Institute for stem cells and regenerative medicine, Shiraz Unive Investigation of treatment of patients with refractory breast cancer using autologous immune cells enriched with NK cells ICR-NKCT-17 Investigation of the safety of autologous immune cells injection enriched with NK (Natural killer) cells to the patients with refractory breast cancer 2018-04-21 anticipated 3 Complete https://irct.ir/trial/22499 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Refractory breast cancer. Autologous NK enriched immune cells injection into the patients every 2 weeks during 3 months. Yes - There is a plan to make this available What will be shared: 1) Clinical and pathological characteristics of the [patients, including tumor type, tumor grade, tumor stage, LN involvement and metastasis at the time of diagnosis 2) Clinical response to the treatment regimen, as well as the pathological and immunological findings before and after cell therapy When: Six months following the publication of the results To whom: Researchers, scientist and physicians Conditions: Using the data for research with the permission of the principal investigators Where to obtain: Dr. Nasrollah Erfani/ Mrs. Somayeh Rezaeifard Shiraz Institute for Cancer Research and Department of Immunology, School of Medicine ُُShiraz University of Medical Sciences Zand Av. Shiraz. Iran Tel: +98 (71) 32303687 ermail: erfanin@sums.ac.ir/ srezaeifard@sums.ac.ir How to obtain: 1) Putting the application 2) Processing the application by the investigators 3) Providing the data in two weeks Comments: -
public Somayeh Rezaeifard
Shiraz Institute for Cancer Research- Medical School- Zand Street-Shiraz
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 3687 srezaeifard@sums.ac.ir Shiraz University of Medical Sciences, Medical School, Shiraz Institute for Cancer Research scientific Dr. Nasrollah erfani
Shiraz Institute for Cancer Research- Medical School- Zand Street-Shiraz
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 3687 erfanin@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with breast cancer, Infiltrative Ductal Carcinoma (IDC) Patients with end stage breast cancer (Stage 4) Patients with refractory breast cancer based on National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) guidelines Triple negative (ER-,PR- and Her2-) breast cancer patients Patients with the minimum age of 18 years old and maximum 60 years old Performance status =0 or 1 Life expectancy for patients: more than 3 months 18 years 60 years Female Patients with autoimmune disease Patients with active infection Patients who spend the intensive radiotherapy Pregnant patients Other Autologous NK enriched immune cells injection into the patients every 2 weeks during 3 months Determining how well NK enriched immune cells can be tolerated in patients. Safety and toxicity will be determined based on Common Terminology Criteria for Adverse Events (CTCAEs) guideline. Timepoint: The period between the first injection and 2 months after the last injection. Method of measurement: According to the CTCAEs [Common Terminology Criteria for Adverse Events]. Immunological responses in the patients. Timepoint: The period between the first injection and 2 months after the last injection. Method of measurement: The flowcytometeric analysis of different immune cells percentage including B, T (CD4+ and CD8+), NK subsets, CD4+ regulatory T cells in PBMCs isolated from the patients. VC for Research and Technology and Institute for stem cells and regenerative medicine, Shiraz Unive Approved 2017-09-17 Ethic committee in research, Shiraz University of Medical Sciences Ethic committee,Shiraz University of Medical Sciences, Zand street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)