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

Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04326959

Acronym

Keloid

Enrollment

Registered

2020-03-30

Start date

2020-09-01

Completion date

2020-12-01

Last updated

2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid

Keywords

Keloid, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium

Brief 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.

Interventions

BIOLOGICALUmbilical Cord-Mesenchymal Stem Cells and Conditioned Medium

Injection of Allogeneic Umbilical Cord Mesenchymal Stem Cells 2 million cell/cm3 in Nacl 1 cc/million cell and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.

BIOLOGICALConditioned Medium

Injection of Conditioned Medium 1 cc/cm3 and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.

BIOLOGICALTriamcinolone Acetonide

Injection of Triamcinolone Acetonide 40 mg/cc/cm3 and booster in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Surgery history of more than 3 months * Has keloid that the maximum size is 15 cm and thickness is 3-5 mm

Exclusion criteria

* Patients with kidney failure * Pregnancy * Breastfeeding * Liver dysfunction * Blood disorders * Currently receiving immunosuppressant therapy (chemotherapy or steroids) * Refusing to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
Alfa SMA-1	3 month after injection	Biomarker
Collagen type 1	3 moth after injection	Biomarker

Secondary

Measure	Time frame	Description
Core Biopsy/Histopathology	3 month after injection	Too evaluate histology of keloid
Ultrasonography	3 month after injection	To see image inside the body

Contacts

Primary ContactAnastasia Dessy Harsono, Master

anastasia.bedahplastik@gmail.com087888363270

Backup ContactCynthia Retna Sartika, Doctor

c.sartika@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026