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

Keloid Clinical Trial

— Keloid  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04326959
• Other study ID #: CT/KLD/03/2020
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Anastasia Dessy Harsono, Master
• Phone: 087888363270
• Email: anastasia.bedahplastik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 1, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

Biological:
• Umbilical 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.
• Conditioned 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.
• Triamcinolone 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alfa SMA-1	Biomarker	3 month after injection
Primary	Collagen type 1	Biomarker	3 moth after injection
Secondary	Core Biopsy/Histopathology	Too evaluate histology of keloid	3 month after injection
Secondary	Ultrasonography	To see image inside the body	3 month after injection