Evaluation of the safety and efficacy of autologous melanocyte keratinocyte suspension transplantation on pigmentation of hypopigmented patches following burn scar
Design
Non-randomized, single center, open lable, phases I/II clinical trial
Settings and conduct
This study is performed in phases 1 and 2 in Hazrat Fatemeh Hospital. In phase 1, first 10 patients are included in the study and if no adverse events are observed, the second phase is performed with 30 patients. After local anesthesia, the skin sample is removed from the gluteal normopigmented skin using a manual dermatome. After isolation of keratinocytes and melanocytes, the cell suspension is transplanted to the hypopigmented area. Patients are then followed up for 6 months for probable side effects and repigmentation rate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 12 to 65 years, Acute burn for more than 6 months ago; exclusion criteria: pregnancy or lactating, Infection in donor or reciept site, History of malignancy, Immuno-suppressive drugs in past 3 months
Intervention groups
Intervention group: Transplantation of autologous melanocyte and keratinocyte suspension to hypopigmented area; Control group: None
Main outcome variables
First endpoint: safety, second endpoint: repigmentation rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051545N1
Registration date:2021-06-16, 1400/03/26
Registration timing:prospective
Last update:2021-06-16, 1400/03/26
Update count:0
Registration date
2021-06-16, 1400/03/26
Registrant information
Name
Amir Bajouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 2537
Email address
bajouri.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase I/II clinical trial of melanocyte and keratinocyte transplantation in hypopigmented burn scar patches
Public title
Cell therapy in hypopigmented patches following burn scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 12 to 65 years
Acute burn for more than 6 months ago
Exclusion criteria:
pregnancy or lactating
Infection in donor or reciept site
History of malignancy
Immuno-suppressive drugs in past 3 months
Age
From 12 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
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
Ethics committee of Iran University of Medical Sciences
Street address
5th floor, Central office, Iran University of Medical Sciences, Hemmat Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.IUMS.REC.1400.155
Health conditions studied
1
Description of health condition studied
Burn scar
ICD-10 code
M61.3
ICD-10 code description
Calcification and ossification of muscles associated with burns
Primary outcomes
1
Description
safety of intervention method
Timepoint
1, 3, and 6 months after transplantation
Method of measurement
medical history and physical exam
Secondary outcomes
1
Description
Repigmentation rate
Timepoint
1, 3, and 6 months after transplantation
Method of measurement
Image J software
Intervention groups
1
Description
Intervention group: Autologous keratinocyte and melanocyte suspension, single dose, 10-15 x10(6) cells, transplantation following laser, Motahari hospital clean room
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Amir Bajouri
Street address
21th st., Asadabadi st.
City
Tehran
Province
Tehran
Postal code
۱۴۳۳۹۳۳۱۱۱
Phone
+98 21 8871 7272
Email
bajouri.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Noor Ahmad Latifi
Street address
21th st., Asadabadi st.
City
Tehran
Province
Tehran
Postal code
۱۴۳۳۹۳۳۱۱۱
Phone
+98 21 8871 7272
Email
dr.noorahmadlatifi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Soheila Naderi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
21th st. Asadabadi st.
City
Tehran
Province
Tehran
Postal code
۱۴۳۳۹۳۳۱۱۱
Phone
+98 21 8871 7272
Email
soheila_naderi2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Bajouri
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Medical Biotechnology
Street address
21th st., Asadabadi st.
City
Tehran
Province
Tehran
Postal code
۱۴۳۳۹۳۳۱۱۱
Phone
+98 21 8871 7272
Email
bajouri.md@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soheila Naderi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
21th st., Asadabadi st,
City
Tehran
Province
Tehran
Postal code
۱۴۳۳۹۳۳۱۱۱
Phone
+98 21 8871 7272
Email
soheila_naderi2@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after blinding the individuals
When the data will become available and for how long
6 months after publishing the manuscript
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In order to analyze the data related to the study outcome
From where data/document is obtainable
Amir bajouri
bajouri.md@gmail.com
What processes are involved for a request to access data/document
After reviewing in the Research Council of Iran University of Medical Sciences can be presented which usually takes 1 to 2 months.