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

NCT05887804 | Completed Phase 4

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

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.

Conditions

Keloid; Stem Cell

Keywords

Keloid therapy; mesenchymal stem cells; keloid volume; POSAS

Outcome Measures

Primary Outcomes (2)

• Keloid volume reduction

  Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit

  15 weeks

• 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.

  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: 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.
• 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: May 24, 2023
• First Posted: June 5, 2023
• Study Start: October 1, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)