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

Phase 1

• Conditions: Keloid
• Interventions: Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium; Biological: Triamcinolone Acetonide; Biological: Conditioned Medium

• Registration Number: NCT04326959
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15
• Study Start: 2020-09-01
• Primary Completion: 2020-09-08
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC-MSCs + CM	Conditioned Medium	A patient will be given UC-MSCs 2 million cells / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.
UC-MSCs + CM	Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium	A patient will be given UC-MSCs 2 million cells / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.
Triamcinolon acetonide	Triamcinolone Acetonide	A patient will be given Triamcinolone acetonide 40 mg / cc / cm3. After 3 weeks the patient will be given Triamcinolone acetonide 40 mg/cc / cm3. The maximum size of Keloid is 15 cm per patient.
CM + CM	Conditioned Medium	A patient will be given CM 1 cc / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.

Primary Outcome Measures

Name	Time	Method
Collagen type 1	3 moth after injection	Biomarker
Alfa SMA-1	3 month after injection	Biomarker

Secondary Outcome Measures

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