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Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial

Primary Purpose

Keloid, Stem Cell

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
umbilical cord-derived mesenchymal stem cells (UC-MSC)
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
Triamcinolone Acetonide (TA)
Sponsored by
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring Keloid therapy, mesenchymal stem cells, keloid volume, POSAS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient has keloids with a length of 2-10 cm and a thickness of 3-5 mm located on the chest, back, abdomen and extremities Patients aged 18 - 55 years Post-surgery patients more than 3 months that cause keloids The patient is willing to fill in the informed consent form Exclusion Criteria: Patients with hypertrophic scars History of kidney failure Hypertension Pregnant and breastfeeding History of blood disorders History of tumor or malignancy Get other keloid therapy outside of the research procedure

Sites / Locations

  • RSPAD Gatot Soebroto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

umbilical cord-derived mesenchymal stem cells (UC-MSC)

umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)

triamcinolone acetonide

Arm Description

UC-MSC was collected in 50 mL of transport medium, which contained alpha minimal essential medium (αMEM [GIBCO 12000-0221]), penicillin/streptomycin (final concentration 300u/mL [GIBCO 15140-122]) and amphotericin B (final concentration 7500ng /mL [JR Scientific 50701]), and processed in less than 8 hours after collection. Group 1 was given UC-MSC 2 million cells/mL/cm3

group 2 was given UC-CM 1 mL/cm3

group 3 was given TA 40 mg/mL/cm3

Outcomes

Primary Outcome Measures

Keloid volume reduction
Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit
The Patient and Observer Scar Assessment Scale (POSAS) score reduction
Symptoms were measured using The Patient and Observer Scar Assessment Scale (POSAS) on the first visit, five weeks, 13 weeks, and 17 weeks after the first visit. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', corresponding to the normal skin situation (i.e., normal pigmentation, no itching). Score 10 equals the most significant difference from normal skin (i.e., the worst imaginable scar or sensation). The symptoms are considered improved if the score gets lower. The total score of both scales can be calculated by summing up the scores of each of the six items. The total score can range from 6 to 60.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
June 5, 2023
Sponsor
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Collaborators
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05887804
Brief Title
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial
Official Title
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
June 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Collaborators
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a double-blind randomized controlled trial (RCT) examining the effect of intralesional injection of umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) on keloids carried out using CONSORT statement. Research is directed at studying keloid volume reduction and changes in POSAS score.
Detailed Description
Patients were screened initially by measuring the length and thickness of the keloids using a ruler. Patients who met the study inclusion criteria were randomly divided into three groups. Each patient in the groups was given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure. Group 1 was given umbilical cord-derived mesenchymal stem cells (UC-MSC) 2 million cells/mL/cm3, group 2 was given umbilical cord-derived conditioned medium(UC-CM) 1 mL/cm3, and group 3 was given triamcinolone acetonide (TA) 40 mg/mL/cm3. All patients received a single dose and 1 booster dose. The percentage of keloid volume regression in each treatment group was calculated by calculating the difference in volume before and after therapy with a 3-dimensional CT-scan, then expressed as a percentage. The CT-scan volume was obtained with the SmartVitrea application (Figure 2), then a POSAS examination will be carried out for subjective and objective assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid, Stem Cell
Keywords
Keloid therapy, mesenchymal stem cells, keloid volume, POSAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients were screened initially by measuring the length and thickness of the keloids using a ruler. Patients who met the study inclusion criteria were randomly divided into 3 groups. Each patient in the groups was given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure. Group 1 was given UC-MSC 2 million cells/mL/cm3, group 2 was given UC-CM 1 mL/cm3, and group 3 was given TA 40 mg/mL/cm3.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The laboratory staff prepared the substances in identical syringes without informing the researchers according to randomization. Data processing was carried out by statisticians and clinicians other than researchers.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
umbilical cord-derived mesenchymal stem cells (UC-MSC)
Arm Type
Experimental
Arm Description
UC-MSC was collected in 50 mL of transport medium, which contained alpha minimal essential medium (αMEM [GIBCO 12000-0221]), penicillin/streptomycin (final concentration 300u/mL [GIBCO 15140-122]) and amphotericin B (final concentration 7500ng /mL [JR Scientific 50701]), and processed in less than 8 hours after collection. Group 1 was given UC-MSC 2 million cells/mL/cm3
Arm Title
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
Arm Type
Experimental
Arm Description
group 2 was given UC-CM 1 mL/cm3
Arm Title
triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
group 3 was given TA 40 mg/mL/cm3
Intervention Type
Biological
Intervention Name(s)
umbilical cord-derived mesenchymal stem cells (UC-MSC)
Intervention Description
Group 1 was injected UC-MSC 2 million cells/mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.
Intervention Type
Biological
Intervention Name(s)
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
Intervention Description
Group 2 was injected UC-CM 1 mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide (TA)
Intervention Description
Group 3 was injected TA 40 mg/mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.
Primary Outcome Measure Information:
Title
Keloid volume reduction
Description
Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit
Time Frame
15 weeks
Title
The Patient and Observer Scar Assessment Scale (POSAS) score reduction
Description
Symptoms were measured using The Patient and Observer Scar Assessment Scale (POSAS) on the first visit, five weeks, 13 weeks, and 17 weeks after the first visit. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', corresponding to the normal skin situation (i.e., normal pigmentation, no itching). Score 10 equals the most significant difference from normal skin (i.e., the worst imaginable scar or sensation). The symptoms are considered improved if the score gets lower. The total score of both scales can be calculated by summing up the scores of each of the six items. The total score can range from 6 to 60.
Time Frame
17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has keloids with a length of 2-10 cm and a thickness of 3-5 mm located on the chest, back, abdomen and extremities Patients aged 18 - 55 years Post-surgery patients more than 3 months that cause keloids The patient is willing to fill in the informed consent form Exclusion Criteria: Patients with hypertrophic scars History of kidney failure Hypertension Pregnant and breastfeeding History of blood disorders History of tumor or malignancy Get other keloid therapy outside of the research procedure
Facility Information:
Facility Name
RSPAD Gatot Soebroto
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10410
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial

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