Optimization of using autologous cell suspension transplantation for the treatment of vitiligo
Design
This study is in phase 2 with a sample size of 15 people and has only one intervention group (without control group) and is not blind and without randomization.
Settings and conduct
This study is done at the skin and stem cell research center of Tehran university of medical sciences and by informing the patient about how to conduct the study, It is performed for the effectiveness of the treatment method and side effects of melanocyte cell suspension transfer along appropriate method. First, a small area of the patient's buttocks is used as a donor area. After preparing the melanocyte cell suspension in the laboratory, the pigment-free area is anesthetized and the epidermis area is removed. The suspension is poured completely on the peeled surface and then fixed at the lesion site with a suitable dressing. The dressing is removed in the first week after the operation. Patients' biometrics are performed before the intervention, 1, 3 and 6 months after transplantation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having no treatment within past 6 months, No pregnancy or breast-feeding, Have a diagnosis of vitiligo with depigmented patch more than 5 cm despite receiving at least 3 months active treatment, No infection at recipient site, No history of keloid and or koebner phenomenon, No active uncontrolled chronic systemic disease. Exclusion criteria: Vitiligo patients with active or progressive disease within last 1 year.
Intervention groups
Intervention group: The epidermis layer of pigment-free area is first removed and then the processed cell suspension is transferred to the desired area and covered with a suitable dressing.
Main outcome variables
Melanin Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N2
Registration date:2021-05-28, 1400/03/07
Registration timing:prospective
Last update:2021-05-28, 1400/03/07
Update count:0
Registration date
2021-05-28, 1400/03/07
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
2021-06-10, 1400/03/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Optimization of autologous melanocyte and keratinocyte cells suspention transplantation for vitiligo treatment
Public title
Optimization of transplantation of cell suspension in the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having no treatment within past 6 months, No pregnancy or breast-feeding, Have a diagnosis of vitiligo with depigmented patch more than 5 cm despite receiving at least 3 months active treatment, No infection at recipient site, No history of keloid and or koebner phenomenon, No history of active hepatitis the B, C, or AIDS, No active uncontrolled chronic systemic disease
Exclusion criteria:
Vitiligo patients with active or progressive disease within last 12 months.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی تهران
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-04-07, 1400/01/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.034
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
disorders of pigmentation
Primary outcomes
1
Description
repigmentation rate
Timepoint
Before, 1, 3 and 6 months after treatment
Method of measurement
The amount of melanin in the treated areas compared to before treatment using a maxameter device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The pigment-free area is first removed and then the processed cell suspension is transferred to the desired area and covered with a suitable dressing.
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, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
Nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahrayian
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@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
Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
009822215558
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
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, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
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