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

• Status: Completed
• Trial end date: 2022-06-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
• Collaborator: Indonesia University
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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