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

PT. Prodia Stem Cell Indonesia

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Keloid

Treatments: Biological: Triamcinolone Acetonide; Biological: Conditioned Medium; Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium

Study type: Interventional

Funder types: Industry

Identifiers

NCT04326959

CT/KLD/03/2020

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

UC-MSCs + CM

Experimental group

Description:

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.

Treatment:

Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium

Biological: Conditioned Medium

CM + CM

Experimental group

Description:

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.

Treatment:

Biological: Conditioned Medium

Triamcinolon acetonide

Experimental group

Description:

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.

Treatment:

Biological: Triamcinolone Acetonide