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In Vitro and clinical assessment of injectable HA in combination with mesenchymal stem cell derived adipose tissue for skin rejuvenation.

Protocol summary

Study aim
In Vitro and clinical assessment of injectable HA in combination with mesenchymal stem cell derived adipose tissue for skin rejuvenation.
Design
Clinical trial with control group, parallel group, double blind, randomised controlled trial, phase 1 on 45 candidates. For randomization rand function of excell have been used.
Settings and conduct
The study aims to enrich the HA by using the ADSC with the aim of investigating the continuity of the rejuvenation with injectable fillers, in double blinded design, the main researcher at skin and stem cell research center, Tehran University of medical sciences knows which kind of treatment was given to the participants. Volunteers receives HA along with cells 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, 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
Intervention groups
Intervention group: The group who receive 3% of HA and ADSC, one time, subdermal injection at one side of the face in the laugh line. Control group: group who receive HA alone, one time, at one side and the laugh line, biometric assessment after one month
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: IRCT20230324057772N3
Registration date: 2024-04-06, 1403/01/18
Registration timing: prospective

Last update: 2024-04-06, 1403/01/18
Update count: 0
Registration date
2024-04-06, 1403/01/18
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
2024-04-20, 1403/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In Vitro and clinical assessment of injectable HA in combination with mesenchymal stem cell derived adipose tissue for skin rejuvenation.
Public title
Investigating the effectiveness of stem cells derived from adipose tissue in combination with 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 30 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 45
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)
Double blinded
Blinding description
Only the researcher doing the study knows which group received fat-derived mesenchymal stem cell 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
13145-784
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.686

Health conditions studied

1

Description of health condition studied
Rejuvination
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 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
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
Ali Akbari Sari
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
akbarisari@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
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Mollapour Sisakht
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Italy St., No.41
City
Tehran
Province
Tehran
Postal code
1417755354
Phone
+98 21 4462 0324
Fax
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 Sisakht
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Italia St, No 41
City
Tehran
Province
Tehran
Postal code
1417755354
Phone
+98 21 4462 0324
Fax
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 Sisakht
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Italia St, No 41
City
Tehran
Province
Tehran
Postal code
1417755354
Phone
+98 21 4462 0324
Fax
Email
Mahsamollapour@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be 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. Postal address: Italia St, No 41. Postal Code: 1417755354
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
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