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

NCT ID: NCT05887804

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-06-09

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.

Conditions

Keloid; Stem Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

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

group 2 was given UC-CM 1 mL/cm3

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

triamcinolone acetonide

group 3 was given TA 40 mg/mL/cm3

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide (TA)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: collaborator

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RSPAD Gatot Soebroto

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

KET-1206

Identifier Type: -

Identifier Source: org_study_id