drugset / Trial / NCT04326959

Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid

NCT04326959

Phase 1/2 Unknown 24 enrolled PT. Prodia Stem Cell Indonesia
RandomizedParallel-groupOpen-labelTreatment

Summary

The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.

Timeline

Start
2020-09-01
Primary completion
2020-09-08
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Secretome Other / unclassified 1 ml Other
Subject Triamcinolone Acetonide Other / unclassified 40 mg Other
Subject mesenchymal stem cells Cell therapy 2e+06 cells Other

Indications