Spots Global Cancer Trial Database for Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients
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Trial Identification
Brief Title: Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients
Official Title: The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)
Study ID: NCT05108012
Interventions
Study Description
Brief Summary: Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.
Detailed Description: 1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royan institute, Tehran, , Iran, Islamic Republic of
Contact Details
Name: Niloufar Shayan Asl, MSc
Affiliation: Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Role: PRINCIPAL_INVESTIGATOR
Name: Monire Mohammad, MSc
Affiliation: Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Role: PRINCIPAL_INVESTIGATOR
Name: Amirali Hamidieh, MD,PhD
Affiliation: Pediatric cell therapy research center, Tehran University of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Marzieh Ebrahimi, PhD
Affiliation: Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Role: STUDY_DIRECTOR
Name: Zohreh Habibi, M.D
Affiliation: Children's Hospital Medical Center, Tehran University of Medical Science, Tehran, Iran
Role: STUDY_DIRECTOR
Name: Abolhossein Shahverdi, PhD
Affiliation: Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Role: STUDY_CHAIR
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