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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-07-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Indonesia University

    collaborator OTHER

  • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-06-09
Completion
2022-06-09

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939817 on ClinicalTrials.gov