Investigating the safety and effectiveness of intradermal injection of stromal vascular fraction cells (SVF) of autologous adipose tissue in the treatment of patients with plaque type psoriasis
Investigating the safety and effectiveness of intradermal injection of stromal vascular fraction cells (SVF) of autologous adipose tissue in the treatment of patients with plaque type psoriasis
Design
This study is conducted as a phase 1 and 2 clinical trial with a control group, double blind, randomized, on 10 patients with psoriasis.
Settings and conduct
This project is carried out in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive diagnosis of psoriasis in the head area; The age of the patients is between 18-50 years, without restrictions on gender; lack of infection and malignancy in the scalp area; Discontinuation of topical treatment at least two weeks in advance, and in the case of patients who benefit from systemic treatment, discontinuation of anti-psoriasis drugs one month in advance; Patient consent to participate in the study Exclusion criteria: pregnancy; breastfeeding; Allergy and sensitivity to the ingredients in the formulation
Intervention groups
The case lesion received vascular stromal cells once, while the control lesion received normal saline.
Main outcome variables
Redness, thickness, crusting, level of involvement, pass, photography of lesions, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N38
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-14, 1403/03/25
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and effectiveness of intradermal injection of stromal vascular fraction cells (SVF) of autologous adipose tissue in the treatment of patients with plaque type psoriasis
Public title
Investigating the injection of adipose tissue stromal vascular cells in the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of psoriasis
Absence of infection and malignancy
Discontinuation of topical treatment at least two weeks in advance, and in the case of patients who benefit from systemic treatment, discontinuation of antipsoriasis drugs one month in advance.
Exclusion criteria:
Pregnancy
Breastfeeding
Allergy and sensitivity to the ingredients in the formulation
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
The two lesions of the patient are divided into intervention and control groups based on the table of random numbers. A table of random numbers is a collection of numbers that are generated completely randomly without a specific pattern or order and are made into a table. In order to use the table of random numbers, the researcher must first determine the direction of reading the numbers in the table (for example, up, down, left or right), the second assumption is that the researcher considers the numbers for different groups (even numbers for the intervention group and numbers individual for the control group). Then the researcher puts his hand on one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data analyzer and evaluator are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-06-13, 1403/03/24
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.012
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Skin redness
Timepoint
Week 0 and 6 months after the last treatment session
Method of measurement
1-Standard psoriasis evaluation questionnaire 2-Questionnaire for evaluating the quality of life of patients with psoriasis 3-Photos of patients before, during and after treatment 4-Using a measurement device
2
Description
Thickness
Timepoint
Week 0 and 6 months after the last treatment session
Method of measurement
1-Standard psoriasis evaluation questionnaire 2-Questionnaire for evaluating the quality of life of patients with psoriasis 3-Photos of patients before, during and after treatment 4-Using a measurement device
3
Description
flaking
Timepoint
Week 0 and 6 months after the last treatment session
Method of measurement
1-Standard psoriasis evaluation questionnaire 2-Questionnaire for evaluating the quality of life of patients with psoriasis 3-Photos of patients before, during and after treatment 4-Using a measurement device
4
Description
level of conflict
Timepoint
Week 0 and 6 months after the last treatment session
Method of measurement
1-Standard psoriasis evaluation questionnaire 2-Questionnaire for evaluating the quality of life of patients with psoriasis 3-Photos of patients before, during and after treatment 4-Using a measurement device
5
Description
Pasi
Timepoint
Week 0 and 6 months after the last treatment session
Method of measurement
Using a measuring device
6
Description
Photography of waste
Timepoint
Week 0 and 6 months after the last treatment session
Method of measurement
Photos of patients before, during and after treatment
Secondary outcomes
1
Description
Side effects (systemic and local)
Timepoint
All patients have been given a phone number that they can call during and after the treatment if needed and report any side effects caused by the medicine.
Method of measurement
All patients have been given a phone number that they can call during and after the treatment if needed and report any side effects caused by the medicine.
Intervention groups
1
Description
Intervention group: stromal vascular fraction cells (extracted from 50 cc of fat tissue) will be injected intradermally once.
Category
Treatment - Other
2
Description
Control group: In another lesion, normal saline will be injected intradermally once.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Fax
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.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
Not applicable
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