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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326959
Recruitment Status : Unknown
Verified July 2020 by PT. Prodia Stem Cell Indonesia.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

Tracking Information
First Submitted Date  ICMJE March 26, 2020
First Posted Date  ICMJE March 30, 2020
Last Update Posted Date July 15, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Alfa SMA-1 [ Time Frame: 3 month after injection ]
    Biomarker
  • Collagen type 1 [ Time Frame: 3 moth after injection ]
    Biomarker
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Core Biopsy/Histopathology [ Time Frame: 3 month after injection ]
    Too evaluate histology of keloid
  • Ultrasonography [ Time Frame: 3 month after injection ]
    To see image inside the body
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
Official Title  ICMJE Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Keloid
Intervention  ICMJE
  • 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.
  • Biological: 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.
    Other Name: Secretome
  • Biological: 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.
Study Arms  ICMJE
  • Experimental: UC-MSCs + CM
    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.
    Interventions:
    • Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium
    • Biological: Conditioned Medium
  • Experimental: CM + CM
    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.
    Intervention: Biological: Conditioned Medium
  • Experimental: Triamcinolon 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.
    Intervention: Biological: Triamcinolone Acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)		 24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04326959
Other Study ID Numbers  ICMJE CT/KLD/03/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party PT. Prodia Stem Cell Indonesia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PT. Prodia Stem Cell Indonesia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PT. Prodia Stem Cell Indonesia
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP