Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000619741
Ethics application status
Approved
Date submitted
31/01/2022
Date registered
26/04/2022
Date last updated
22/10/2023
Date data sharing statement initially provided
26/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of adipose-derived stem cells as treatment of hypertrophic scar: a non-randomized controlled trial
Scientific title
The efficacy of adipose-derived stem cells as treatment of hypertrophic scar: a non-randomized controlled trial
Secondary ID [1] 306231 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic scar 324957 0
Condition category
Condition code
Skin 322391 322391 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. The first treatment group will be hypertrophic scars receiving injections of adipose-derived stem cells (ASCs) suspended in ASC conditioned medium. The suspended ASCs will be injected into hypertrophic scar with a dose of 1,000,000 cells in 1 ml of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections.
Injections will be done by a single doctor.
2. The second treatment group will be hypertrophic scars receiving injections of ASC conditioned medium without ASCs in it, with a dose of 1 ml of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections.
Injection will be performed by the same doctor as the doctor in the first treatment group.

The volume of injections given will be recorded in a case report form and will be audited at the end of the study. The method of allocation used is consecutive allocation based on recruitment process following the order of: 7 subjects receiving ASC and 7 subjects receiving ASC conditioned medium.
Intervention code [1] 322635 0
Treatment: Other
Comparator / control treatment
The control group will be hypertrophic scars receiving triamcinolone acetonide 10 mg/mL (corticosteroid) injections with a dose of 1 mL of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections.
Control group
Active

Outcomes
Primary outcome [1] 330167 0
POSAS (The Patient and Observer Scar Assessment Scale) Questionnaire
Timepoint [1] 330167 0
Right before biopsy 1; 2 weeks after biopsy 1 (right before injection 1); right before injection 2 (7-10 days after injection 1); right before injection 3 (7-10 days after injection 2); 7-10 days after injection 3; 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2); 2 weeks after biopsy 2
Primary outcome [2] 330168 0
Changes in histopathology structures of the scar tissue (a 3-mm punch biopsy will be performed on the area of scar and evaluated by a single pathologist)
Timepoint [2] 330168 0
2 weeks before injection 1 and 3 months after injection 1
Primary outcome [3] 330169 0
Thickness of scar tissue (evaluated with ultrasonography/USG)
Timepoint [3] 330169 0
2 weeks before injection 1 and 3 months after injection 1
Secondary outcome [1] 405102 0
Color of scar (evaluated with POSAS Questionnaire)
Timepoint [1] 405102 0
Right before biopsy 1, 2 weeks after biopsy 1 (right before injection 1), right before injection 2 (7-10 days after injection 1), right before injection 3 (7-10 days after injection 2), 7-10 days after injection 3, 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2), 2 weeks after biopsy 2
Secondary outcome [2] 405103 0
Elasticity of scar tissue (evaluated with durometer)
Timepoint [2] 405103 0
Right before biopsy 1, 2 weeks after biopsy 1 (right before injection 1), right before injection 2 (7-10 days after injection 1), right before injection 3 (7-10 days after injection 2), 7-10 days after injection 3, 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2), 2 weeks after biopsy 2
Secondary outcome [3] 405104 0
Area of scar (evaluated manually with measuring tape)
Timepoint [3] 405104 0
Right before biopsy 1, 2 weeks after biopsy 1 (right before injection 1), right before injection 2 (7-10 days after injection 1), right before injection 3 (7-10 days after injection 2), 7-10 days after injection 3, 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2), 2 weeks after biopsy 2

Eligibility
Key inclusion criteria
- The subject has a hypertrophic scar which has persisted for at least 3 months after the initial wound healed
- The hypertrophic scar is of an area of at least 1 x 1 cm2
- The hypertrophic scar is at least 5-15 mm in thickness, confirmed with ultrasonography
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The scar is diagnosed as keloid
- The subject has systemic conditions such as diabetes mellitus, hypertension, etc
- The subject smoked or consumed alcohol within the last 6 months
- The hypertrophic scar received corticosteroid injection therapy within the last month
- Subjects have allergies to penicillin, streptomycin, and amphotericin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 24510 0
Indonesia
State/province [1] 24510 0
Jakarta

Funding & Sponsors
Funding source category [1] 310578 0
University
Name [1] 310578 0
Program Pendanaan Perancangan dan Pengembangan Purwarupa (P5) by Universitas Indonesia
Country [1] 310578 0
Indonesia
Primary sponsor type
Individual
Name
Theddeus O. H. Prasetyono
Address
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country
Indonesia
Secondary sponsor category [1] 311778 0
None
Name [1] 311778 0
Address [1] 311778 0
Country [1] 311778 0
Other collaborator category [1] 282133 0
Hospital
Name [1] 282133 0
Unit Pelayanan Terpadu Sel Punca Rumah Sakit Cipto Mangunkusumo-Fakultas Kedokteran Universitas Indonesia
Address [1] 282133 0
CMU 2 Building 5th floor, Cipto Mangunkusumo National Central Public Hospital, Kimia street No. 40, Pegangsaan, Menteng, Central Jakarta, Jakarta 10320
Country [1] 282133 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310185 0
Health Research Ethics Committee Faculty of Medicine Universitas Indonesia/ Cipto Mangunkusumo Hospital
Ethics committee address [1] 310185 0
Ethics committee country [1] 310185 0
Indonesia
Date submitted for ethics approval [1] 310185 0
15/10/2019
Approval date [1] 310185 0
09/12/2019
Ethics approval number [1] 310185 0
19-10-1265

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116790 0
Prof Theddeus Octavianus Hari Prasetyono
Address 116790 0
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country 116790 0
Indonesia
Phone 116790 0
+62817858899
Fax 116790 0
Email 116790 0
[email protected]
Contact person for public queries
Name 116791 0
Theddeus Octavianus Hari Prasetyono
Address 116791 0
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country 116791 0
Indonesia
Phone 116791 0
+62817858899
Fax 116791 0
Email 116791 0
[email protected]
Contact person for scientific queries
Name 116792 0
Theddeus Octavianus Hari Prasetyono
Address 116792 0
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country 116792 0
Indonesia
Phone 116792 0
+62817858899
Fax 116792 0
Email 116792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not take the consent from the subject to have their individual data accessible to public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.