Safety and efficacy assessment of adipose-derived mesenchymal stem cell conditioned media in combination with crosslinked-hyaluronic acid for skin rejuvenation: an in vitro and clinical study (phase I & II)
Enrichment of the optimal percentage of HA using the optimal percentage of culture medium derived from ADSC with the aim of increasing the continuity of the rejuvenation method with injectable fillers
Design
Parallel group trial contian control group, single blind, design for 35 candidate in phase 1 and 2 clinical trial
Settings and conduct
The study aims to enrich the HA by using the culture medium derived from ADSC with the aim of investigating the continuity of the rejuvenation with injectable fillers, in a blinded design, the main researcher knows which kind of treatment was given to the participants. Volunteers receives HA along with supernatant on one side of the face in the smile line area and HA alone on the other side.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male and female aged about 35 to 65 years old, having no anatomic disorder in the face, the candidate with moderate wrinkles according to Glogue scale 2-4.
Exclusion criteria: Heavy smokers or drinkers, applying skin rejuvenation intervention in the face in the past 6 months or during the study, a candidate with wrinkles according to a Glogue scale 1 and 5, the candidate with a history of related skin diseases
Intervention groups
The intervention group receives 1cc of HA in combination with the supernatant of ADSC on one side of the smile line for candidates between the ages of 35 and 65. The study runs in parallel and the candidate receives hyaluronic acid alone on the other side of the face.
Main outcome variables
Change in melanin production; change in skin elasticity; Change in skin wrinkle; durability of HA at the injection site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230324057772N2
Registration date:2024-02-13, 1402/11/24
Registration timing:prospective
Last update:2024-02-13, 1402/11/24
Update count:0
Registration date
2024-02-13, 1402/11/24
Registrant information
Name
Mahsa Mollapour Sisakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4462 0324
Email address
mahsamollapour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-14, 1403/02/25
Expected recruitment end date
2024-11-15, 1403/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy assessment of adipose-derived mesenchymal stem cell conditioned media in combination with crosslinked-hyaluronic acid for skin rejuvenation: an in vitro and clinical study (phase I & II)
Public title
Adipose-derived mesenchymal stem cell conditioned media in combination with crosslinked-hyaluronic acid for skin rejuvenation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female, age about 35 to 65 years old
Having no anatomic disorder in face
Candidate with mild to moderate wrinkles according to Glogue scale 2-4
Normal mental health based on the self assesment
Having a good cooperation with research team
Exclusion criteria:
Heavy smokers or drinkers
Applying skin rejuvination intervention in face at past 6 months or during the study
Having a mental disorder based on the self assesment
Candidate with wrinkles according to Glogue scale 1 and 5
Having an obsessed disorder
Having any related skin disorder
Age
From 35 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, this method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = Active, Tails = Placebo. Implementation and treatment of assignments are completely unpredictable.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher doing the study knows which group received fat-derived mesenchymal stem cell supernatant in combination with crossed-link HA treatment or only crossed-link HA until the trial is over.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
6th floor, Qods Ave., Keshavarz Blvd., Tehran University of Medical Sciences, Central building
City
Tehran
Province
Tehran
Postal code
1417755354
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.503
Health conditions studied
1
Description of health condition studied
rejuvenation
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue
Primary outcomes
1
Description
Quantity of nasolabial fold wrinkle - Extension
Timepoint
Before the injection and after 1 and 3 months
Method of measurement
Biometry with visioface & skin sonography
2
Description
Quality of nasolabial fold wrinkle - deep
Timepoint
Before the injection and after 1 and 3 months
Method of measurement
Visio face and skin sonography
Secondary outcomes
1
Description
Skin elastisity
Timepoint
Before the intervention, 1 and 3 months
Method of measurement
Skin sonography
2
Description
Melanin level in skin
Timepoint
Before the intervention, 1 and 3 months
Method of measurement
Biometry with colorimeter
Intervention groups
1
Description
Intervention group: The group who receive 3% of HA and supernatant of ADSC, one time, subdermal injection at one side of the face in the laugh line
Category
Treatment - Other
2
Description
Control group: group who receive HA alone, one time, at one side and the laugh line, biometric assessment after one month
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and stem cell research cenetr, Tehran University of Medical Sciences
Full name of responsible person
Mahsa Mollapour
Street address
No.4, Maryam Dead End, South Andarzgo Blvd., Kamraniyeh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
13145-784
Phone
+98 21 2220 1710
Email
mahsamollapour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No.4, Maryam Dead End, South Andarzgo Blvd., Kamraniyeh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
13145-784
Phone
+98 21 2220 1710
Email
Dr_nilforoush@yahoo.com
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
Mahsa Mollapour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No.4, Maryam Dead End, South Andarzgo Blvd., Kamraniyeh Ave., Tehran, Iran
City
تهران
Province
Tehran
Postal code
13145-784
Phone
+98 21 8605 2887
Email
mahsamollapour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Mollapour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No.4, Maryam Dead End, South Andarzgo Blvd., Kamraniyeh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
13145-784
Phone
+98 21 2220 1710
Email
mahsamollapour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Mollapour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No.4, Maryam Dead End, South Andarzgo Blvd., Kamraniyeh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
13145-784
Phone
+98 21 2220 1710
Email
mahsamollapour@gmail.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 is potentially shareable after de-identifying individuals
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
The use and analysis of data is not allowed without the permission of the principal investigator
From where data/document is obtainable
Information will be send after receiving email request by principal investigator
What processes are involved for a request to access data/document
After receiving the email, the information will be provided to the qualified applicant within a maximum period of one month