The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled Trial

NCT05939817 | Completed Phase 4

• 1 other identifier: KET-1206/UN2.F1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to observe the potency of umbilical cord-derived mesenchymal stem cells (UC-MSC) and umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) in keloid therapy, measured by the decrease in the type 1:3 collagen ratio and the increase of IL-10 levels carried out using CONSORT statement.

Conditions

Keloid; Stem Cell

Keywords

Keloid therapy; mesenchymal stem cells; Interleukin-10; collagen ratio

Outcome Measures

Primary Outcomes (2)

• Type 1:3 collagen ratio reduction

  Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination are Sirius red staining to evaluate collagen structure under a polarizing lens. Calculation of changes in the ratio of type 1 to type 3 collagen levels was carried out by dividing the ratio of collagen before treatment from the ratio of collagen after each treatment. When visualized under a polarizing lens, type-3 collagen will appear green-birefringence and type-1 collagen will appear yellow-birefringence. The collagen ratio was obtained by dividing the composition of collagen type 1 to collagen type 3 in Sirius red staining under polarizing lenses.

  17 weeks

• IL-10 levels increase

  Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination is In Vitro quantitative examination using the ELISA method to examine IL-10.

  17 weeks

Study Arms (3)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

group 2 was given UC-CM 1 mL/cm3

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

triamcinolone acetonide

ACTIVE COMPARATOR

group 3 was given TA 40 mg/mL/cm3

Drug: Triamcinolone Acetonide (TA)

Interventions

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

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

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

Triamcinolone Acetonide (TA) 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.

triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto: lead
• Indonesia University: collaborator

Study Sites (1)

RSPAD Gatot Soebroto

Jakarta Pusat, DKI Jakarta, 10410, Indonesia

Location

MeSH Terms

Conditions

Keloid

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This double blind, randomized controlled trial (RCT) is carried out according to CONSORT statement. Identical syringes containing the substances were prepared by laboratory staff, in which the researchers were not informed of the syringe contents, in accordance to computerized block randomization. Data processing was then carried out by other statisticians and clinicians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 11, 2023
• Study Start: October 1, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)