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

Primary Purpose

Keloid

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium
Conditioned Medium
Triamcinolone Acetonide
Sponsored by
PT. Prodia Stem Cell Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring Keloid, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    UC-MSCs + CM

    CM + CM

    Triamcinolon acetonide

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Alfa SMA-1
    Biomarker
    Collagen type 1
    Biomarker

    Secondary Outcome Measures

    Core Biopsy/Histopathology
    Too evaluate histology of keloid
    Ultrasonography
    To see image inside the body

    Full Information

    First Posted
    March 26, 2020
    Last Updated
    July 14, 2020
    Sponsor
    PT. Prodia Stem Cell Indonesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04326959
    Brief Title
    Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
    Acronym
    Keloid
    Official Title
    Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    September 8, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    PT. Prodia Stem Cell Indonesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keloid
    Keywords
    Keloid, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UC-MSCs + CM
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    CM + CM
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Triamcinolon acetonide
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Biological
    Intervention Name(s)
    Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Conditioned Medium
    Other Intervention Name(s)
    Secretome
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Triamcinolone Acetonide
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Alfa SMA-1
    Description
    Biomarker
    Time Frame
    3 month after injection
    Title
    Collagen type 1
    Description
    Biomarker
    Time Frame
    3 moth after injection
    Secondary Outcome Measure Information:
    Title
    Core Biopsy/Histopathology
    Description
    Too evaluate histology of keloid
    Time Frame
    3 month after injection
    Title
    Ultrasonography
    Description
    To see image inside the body
    Time Frame
    3 month after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anastasia Dessy Harsono, Master
    Phone
    087888363270
    Email
    anastasia.bedahplastik@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cynthia Retna Sartika, Doctor
    Email
    c.sartika@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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