Investigation the effect of injection of cellular plasma gel with skin fibroblasts in skin rejuvenation
Design
Clinical trial without control group, community based, not blinded, Non-randomised controlled study
Settings and conduct
This study is related to dermatology field and will be done in Afzali pour hospital and Cell Therapy and Regenerative medicine Comprehensive Center of Kerman University of medical sciences. After case selection by physician, skin sample is isolated and cultured. After preparation of cellular plasma gel with fibroblasts, it will be injected by physician to patient. Injection will be done 3 times with the period of 3 months and 2 months after the last injection skin alternations of patient will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Presence of aging signs of skin with grade 3 or 5
2. Patients aged between 30-50 years
3. Patients desire to biopsy
Exclusion Criteria:
1. Individuals with systematic or local retinoid medications.
2. Patients with history of hemorrhagic disorders or patients who received anticoagulant treatment recently
3. Any factors that inhibit low invasive techniques
4. Patients with autoimmune diseases.
5. Doing skin procedures and racer-facing lasers
Intervention groups
Skin fibroblasts with plasma gel prepared from own patient, 3 times with the interval of every 3 months is injected into patient's skin and after 2 months from the last injection, skin alternation is evaluated.
Main outcome variables
Improvement in elasticity, moisture, pigmentation distribution, sebum activity, oil and wrinkle of skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140911019125N5
Registration date:2020-03-05, 1398/12/15
Registration timing:prospective
Last update:2020-03-05, 1398/12/15
Update count:0
Registration date
2020-03-05, 1398/12/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2021-10-10, 1400/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of injection of cellular plasma gel with skin fibroblasts in skin rejuvenation
Public title
Study the effect of injection of plasma gel contained with skin fibroblasts in rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of aging signs of skin with grade 3 or 5
Patients aged between 30-50 years
Patients desire to biopsy
Exclusion criteria:
Individuals with systematic or local retinoid medications.
Patients with history of hemorrhagic disorders or patients who received anticoagulant treatment recently
Any factors that inhibit low invasive techniques
Patients with autoimmune diseases.
Doing skin procedures and racer-facing lasers
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethics committee of Kerman University of Medical Sciences
Street address
Haft Bagh Blvd, Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KMU.REC.1398.645
Health conditions studied
1
Description of health condition studied
Skin Rejuvenation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skin Elasticity
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Specific Equipment
2
Description
Skin Moisture
Timepoint
Before intervention and 2 month after intervention
Method of measurement
Specific Equipment
3
Description
Skin Pigmentation distribution
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Specific Equipment
4
Description
Sebum Activity
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Specific Equipment
5
Description
Skin oil
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Specific Equipment
6
Description
Skin Wrinkle
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, after sampling from patient and isolation of skin fibroblasts, plasma gel is prepared and coated with cells and injected into specific site of patient's skin.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Azadeh Mohebbi
Street address
Imam Khomeini Highway, Afzali pour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
mohebbiazadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Haft bagh Blvd. kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft bagh Blvd, kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft bagh Blvd, kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft bagh Blvd, kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional data.
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
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them
From where data/document is obtainable
1- Phone: 034-31325374 2- e-mail: afarsinejad@kmu.ac.ir 3- Fax: 034-31325375 4- address: Haft bagh Blvd, Kerman university of medical science Dr. Alireza Farsinejad
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.