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

Sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto (Other)

Overall Status

Completed

CT.gov ID

NCT05887804

Collaborator

Indonesia University (Other)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Keloid Stem Cell	Biological: umbilical cord-derived mesenchymal stem cells (UC-MSC) Biological: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) Drug: Triamcinolone Acetonide (TA)	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Jun 9, 2022

Actual Study Completion Date :

Jun 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: umbilical cord-derived mesenchymal stem cells (UC-MSC) 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	Biological: umbilical cord-derived mesenchymal stem cells (UC-MSC) 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.
Experimental: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) group 2 was given UC-CM 1 mL/cm3	Biological: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) 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.
Active Comparator: triamcinolone acetonide group 3 was given TA 40 mg/mL/cm3	Drug: Triamcinolone Acetonide (TA) 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.

Arm

Intervention/Treatment

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

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

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

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.

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

group 2 was given UC-CM 1 mL/cm3

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

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.

Active Comparator: triamcinolone acetonide

group 3 was given TA 40 mg/mL/cm3

Drug: Triamcinolone Acetonide (TA)

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.

Outcome Measures

Primary Outcome Measures

Keloid volume reduction [15 weeks]
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 [17 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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