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

KET-1206/UN2.F1

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.

2021-10-01

2022-06-09

2022-06-09

Completed

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-07-11