NCT04326959

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

7 days

First QC Date

March 26, 2020

Last Update Submit

July 14, 2020

Conditions

Keloid

Keywords

KeloidAllogeneic Mesenchymal Stem CellsUmbilical CordConditioned Medium

Outcome Measures

Primary Outcomes (2)

  • Alfa SMA-1

    Biomarker

    3 month after injection

  • Collagen type 1

    Biomarker

    3 moth after injection

Secondary Outcomes (2)

  • Core Biopsy/Histopathology

    3 month after injection

  • Ultrasonography

    3 month after injection

Study Arms (3)

UC-MSCs + CM

EXPERIMENTAL

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.

Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned MediumBiological: Conditioned Medium

CM + CM

EXPERIMENTAL

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.

Biological: Conditioned Medium

Triamcinolon acetonide

EXPERIMENTAL

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.

Biological: Triamcinolone Acetonide

Interventions

Umbilical Cord-Mesenchymal Stem Cells and Conditioned MediumBIOLOGICAL

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.

UC-MSCs + CM
Conditioned MediumBIOLOGICAL

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.

Also known as: Secretome
CM + CMUC-MSCs + CM
Triamcinolone AcetonideBIOLOGICAL

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.

Triamcinolon acetonide

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keloid

Interventions

Culture Media, ConditionedSecretomeTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Culture MediaLaboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and UsesEquipment and SuppliesMetabolomeMetabolismTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Anastasia Dessy Harsono, Master

CONTACT

087888363270anastasia.bedahplastik@gmail.com

Cynthia Retna Sartika, Doctor

CONTACT

c.sartika@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

September 1, 2020

Primary Completion

September 8, 2020

Study Completion

December 1, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07