Cell Therapy using NK cells in Patients with Hepatocellular carcinoma
Design
A pilot single arm clinical trial of 3 patients
Settings and conduct
1- Patient selection. 2- Isolation of mononuclear cells isolated using ficoll and density gradient centrifugation and then using an NK cells isolation kit, NK cells will be separated 3- Pretreatment of NK cells with Anti-NKG2A 4- Injection protocol including conditioning regime and intravenously injection of 7x10^8 cells
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age of people between 20 and 60 years
- Patients receiving the same chemotherapy regimen.
- Patients who have almost the same tumor size.
- Diffuse form in terms of histopathology.
- All patients with active hepatitis B or C were treated with appropriate drugs and treated with targeted drugs.
- Have not undergone a liver transplant before.
Exclusion criteria:
- Pregnant or lactating women
- People with hepatitis A, hepatitis E, AIDS, or other infectious diseases
- Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days
- Patients with other serious systemic and psychiatric diseases
- Having a history of autoimmune diseases and hypersensitivity
- History of receiving any type of cell therapy in the last 6 months
- Diseases such as diabetes mellitus, unstable angina, or myocardial infarction within 3 months
Intervention groups
Injection of the number of 7x10^5 NK cells in 3 periods with an interval of 5 days to 3 patients with HCC
Main outcome variables
Follow- up of patients after each injection and 28 days after the last injection based on clinical response and safety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N41
Registration date:2024-06-15, 1403/03/26
Registration timing:registered_while_recruiting
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy using natural killer cells pretreatment with Anti-NKG2A in patients with hepatocellular carcinoma
Public title
Cell therapy using natural killer cells pretreatment with Anti-NKG2A in patients with hepatocellular carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of people between 20 and 60 years- Patients receiving the same chemotherapy regimen. Patients who have almost the same tumor size. Diffuse-form in terms of histopathology. Laboratory criteria for the proper functioning of vital organs in the form of:Liver function:Child-pugh A/Bserum aspartate aminotransferase (AST) ≤100 IU/Lalanine aminotransferase (ALT) ≤100 IU/Lserum total bilirubin ≤2 mg/dLRenal function: ≤1.5 mg/dL serum creatinineCardiac function: Absence of heart enzyme and ECG abnormalities, the survival expectancy is more than 6 months.leukocyte count ≥3000/mm3neutrophil count ≥1500/mm3platelet count ≥100,000/mm3hemoglobin ≥9.0 g/dLblood urea nitrogen level ≤25 mg/dL- All patients with active hepatitis B or C were treated with appropriate drugs and treated with targeted drugs.- Women must not be lactating or pregnant, must have a negative serum human chorionic gonadotropin B (HCG) test within 7 days prior to transplant day, and must agree to use an acceptable and reliable method of contraception during the study.- Have not undergone a liver transplant before.- All patients and donors sign an informed consent form.
Exclusion criteria:
Pregnant or lactating women- People with hepatitis A, hepatitis E, AIDS or other infectious diseases- Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days- Patients with other serious systemic and psychiatric diseases- Having a history of autoimmune diseases and hypersensitivity- History of receiving any type of cell therapy in the last 6 months- Simultaneous participation in another clinical trial- Diseases such as diabetes mellitus, unstable angina or myocardial infarction within 3 months
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of The Institute of Pharmaceutical Sciences -Tehran University of Medical
Street address
13rd Floor, Block A, Central Headquarters of the Ministry of Health, Treatment, and Medical Education, between South Flamek and Zarafshan, Simai Iran St., Quds town (west), Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713119
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.015
Health conditions studied
1
Description of health condition studied
hepatocellular carcinoma
ICD-10 code
C22.0Liver
ICD-10 code description
C22.0
Primary outcomes
1
Description
Checking the safety and toxicity of the injected cells
Timepoint
28 days
Method of measurement
Any side effects related to cell injection will be checked and recorded during the injection and up to 28 days after the injection.If a complication is seen during or after the infusion, the following actions will be taken based on the CTCAE guideline:In grade 1, only the infusion is stopped.In grades 2 and 3, the infusion is stopped along with anti-allergic treatments, including corticosteroids and antihistamines.In grade 4, in addition to the above, resuscitation measures and care in the ICU department are also recommended.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous injection of the number of 7x10^5 NK cells in 3 periods with an interval of 5 days to 3 patients with Hepathocellular carcinoma
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr Maryam Barkhordar
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
تهران
Province
Tehran
Postal code
1411713135
Phone
+98 911 357 0540
Email
barkhordarm.n@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Barkhordar
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
تهران
Province
Tehran
Postal code
1411713135
Phone
+98 913 185 6733
Email
barkhordarm.n@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr javad verdi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
تهران
Province
Tehran
Postal code
1417755469
Phone
+98 911 357 0540
Email
javadverdi2019@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Ahmadvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 4140
Email
ahmadvand.mohamad64@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Tavakoli
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Cell Therapy
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
shirintavakoli67@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available