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
Condition: Keloid; Stem Cell
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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 three 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 umbilical cord-derived mesenchymal stem cells (UC-MSC) 2
      million cells/mL/cm3, group 2 was given umbilical cord-derived conditioned medium(UC-CM) 1
      mL/cm3, and group 3 was given triamcinolone acetonide (TA) 40 mg/mL/cm3. All patients
      received a single dose and 1 booster dose. The percentage of keloid volume regression in each
      treatment group was calculated by calculating the difference in volume before and after
      therapy with a 3-dimensional CT-scan, then expressed as a percentage. The CT-scan volume was
      obtained with the SmartVitrea application (Figure 2), then a POSAS examination will be
      carried out for subjective and objective assessment.
    

Intervention name(s): umbilical cord-derived mesenchymal stem cells (UC-MSC); umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM); Triamcinolone Acetonide (TA)
Intervention type(s): Biological; Biological; Drug
Intervention description(s): 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.; 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.; 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.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keloid therapy; mesenchymal stem cells; keloid volume; POSAS