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

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Status and phase: Completed; Phase 4

Conditions: Keloid; Stem Cell

Treatments: Biological: umbilical cord-derived mesenchymal stem cells (UC-MSC); Biological: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM); Drug: Triamcinolone Acetonide (TA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05887804

KET-1206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

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

Experimental group

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

Treatment:

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

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

Experimental group

Description:

group 2 was given UC-CM 1 mL/cm3

Treatment:

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

triamcinolone acetonide

Active Comparator group

Description:

group 3 was given TA 40 mg/mL/cm3

Treatment:

Drug: Triamcinolone Acetonide (TA)