Evaluation of the efficacy and safety of autologous cell transplantation without melanocyte-keratinocyte culture in suspension and gel form in the treatment of patients with persistent vitiligo: Phase one clinical trial
Evaluation of the efficacy and safety of autologous cell transplantation without melanocyte-keratinocyte culture in suspension and gel form in the treatment of patients with persistent vitiligo: Phase one clinical trial
Design
Phase 1, sample size of 10 people, with an intervention group and a control group, not blinded
Settings and conduct
This project is carried out in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, and with the patient's information about how to conduct the study, in order to evaluate the effectiveness of the treatment method and the side effects of transferring the melanocyte cell suspension and the gel containing the cells along with the dermabrasion method as an evaluation. It is done before and after. First, a small area of the patient's buttocks is used as a donor area. After the melanocyte cell suspension is prepared in the laboratory, the depigmented area is numbed and the epidermal area is removed. The suspension is completely poured on the exfoliated surface and then it is fixed in the lesion with a suitable dressing. In another patch, gel containing cells is placed. The dressing is removed in the first week after the operation. Biometry of patients is performed before intervention, 1, 3 and 6 months after transplantation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having no treatment within past 6 months, Exclusion criteria: Vitiligo patients with active or progressive disease within last 12 months.
Intervention groups
Intervention group: A diseased patch of patient dermabrade and a gel containing cells is placed on the area and bandaged. Control group: A patch of patient dermabrade and the cell suspension is sprayed on the area and bandaged.
Main outcome variables
Melanin Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N22
Registration date:2023-02-05, 1401/11/16
Registration timing:prospective
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
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
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of autologous cell transplantation without melanocyte-keratinocyte culture in suspension and gel form in the treatment of patients with persistent vitiligo: Phase one clinical trial
Public title
Evaluation of autologous cell transplantation without melanocyte-keratinocyte culture in suspension and gel form in the treatment of patients with persistent 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
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-05-09, 1401/02/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.119
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: A diseased patch of patient dermabrade and a gel containing cells is placed on the area and bandaged.
Category
Treatment - Other
2
Description
Control group: A patch of patient dermabrade and the cell suspension is sprayed on the area and bandaged.
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
Phone
+98 21 2665 7438
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
Akbar Fotouhi
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
Skin and Stem Cell Research Center, 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, 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, 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