_ To study the safety and efficasy of autologous fibroblast transplantation into atrophic scar of cutaneous leishmaniasis.
Design
A pilot study on Safety and Efficacy of Autologous Human Fibroblasts Transplantation in Regeneration of Atrophic Cutaneous Leishmaniasis Scar. Five patients are treated with their autologous dermal fibroblasts. The scars are investigated before and after transplantation.
Settings and conduct
In this pilot study, ear skin biopsies taken from patients at Center of Research and Training in Skin Diseases and Leprosy. The samples are moved to clean room at Iran University of Medical Sciences to isolate fibroblasts.The cells are injected into the lesions 3 times with 2 months intervals and 2, 6, and 12 months follow ups using VisioFace, Sonography and Cotometer.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1- Ages 15-65
2- Scar lesions caused by Cutaneous leishmaniasis grade 3 to 7
3- The willingness to provide informed consent,the ability to communicate with the investigator during follow ups.
Exclusion Criteria
1-Use of Retinoids in the last 6 months
2- Pregnancy
3- Laser therapy in the last 6 months
4- Cancer or any chronic systemic disease
5-Chemical therapy
6-Mesotherapy
7-Active infection to Leishmaniasis
8-Oragan or cell transplantation
9-Autoimmune disease
10-Breast feeding
11- Dermal Filler in the last 6 months
12- Plastic surgery at the site of Cutaneous leishmaniasis lesion
13-Use of Corticosteroids
14- Excessive exposure to sun
15-Participation in other clinical trials, using systemic medication or other treatment that might interfere with this study
16- Evidence of infection in the lesion or elsewhere on body.
Intervention groups
- Clinical grade Autologous Fibroblast Transplantationin the lesions caused by cutaneous leishmaniasis .
Investigation on Safety and Efficacy of Autologous Human Fibroblasts Transplantation in Regeneration of Atrophic Cutaneous Leishmaniasis Scar.
Public title
Fibroblast in Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 15-65
Scar lesions caused by Cutaneous leishmaniasis grade 3 to 7;
The willingness to provide informed consent for participation in the trial and the ability to communicate with the investigator during follow ups.
Exclusion criteria:
Use of Retinoids in the last 6 months
Pregnancy
Laser therapy in the last 6 months
Cancer or any chronic systemic disease
Chemical therapy
Mesotherapy
Active infection to Leishmaniasis in the scar
Oragan or cell transplantation
Autoimmune disease
Breast feeding
Dermal Filler in the last 6 months
Plastic surgery at the site of Cutaneous leishmaniasis lesion
Use of Corticosteroids
Excessive exposure to sun.
Subjects who are enrolled in any other clinical trial using systemic medication; or any other treatment that might interfere with this study
Subjects with evidence of infection on area to be treated or elsewhere on body.
Age
From 15 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
More than 1 sample in each individual
Number of samples in each individual:
5
The group treated with Autologous Fibroblast
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
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
TEHRAN
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.IUMS.REC.1399.196
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Dermal thickness
Timepoint
Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts
Method of measurement
Sonography
2
Description
Elasticity
Timepoint
Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts
Method of measurement
Cotometer
3
Description
wound Diameter
Timepoint
Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts
Method of measurement
visioFace
Secondary outcomes
1
Description
Patients Satisfaction
Timepoint
Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Fibroblast Transplantation on number of 5 patients suffered from Cutaneous leishmaniasis to regenerate scar lesions after three subsequent fibroblast injections (2o mil/ turn) with 2 months intervals. scars are evaluated before and after transplantation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Ali Khamesipour
Street address
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
ali.khamesipour@gmail.com
Web page address
http://crtsdl.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motevalian
Street address
ran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Fax
+98 21 8862 2307
Email
research-m@iums.ac.ir
Web page address
https://www.iums.ac.ir
Grant name
98-4-99-16804
Grant code / Reference number
98-4-99-16804
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
Faezeh Faghihi
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4722
Email
faghihi.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faezeh Faghihi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4722
Email
faghihi.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faezeh Faghihi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4722
Fax
+98 21 8862 2578
Email
faghihi.f@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Paper- Partly( main measurements)
When the data will become available and for how long
After paper acceptance
To whom data/document is available
Scientists and the health industries
Under which criteria data/document could be used
Formal contact
From where data/document is obtainable
Faezeh Faghihi, Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran. +98 21 86704722
What processes are involved for a request to access data/document
Formal written request-
Acceptance of Research Committee of Cellular and Molecular Research Center at Iran University of Medical Sciences.