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

PHASE4CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

June 9, 2022

Study Completion Date

June 9, 2022

Conditions
KeloidStem Cell
Interventions
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.

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.

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.

Trial Locations (1)

10410

RSPAD Gatot Soebroto, Jakarta Pusat

All Listed Sponsors
collaborator

Indonesia University

OTHER

lead

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

OTHER

NCT05939817 - 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 | Biotech Hunter | Biotech Hunter