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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326959
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Keloid Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium Biological: Conditioned Medium Biological: Triamcinolone Acetonide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 8, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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

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.
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.




Primary Outcome Measures :
  1. Alfa SMA-1 [ Time Frame: 3 month after injection ]
    Biomarker

  2. Collagen type 1 [ Time Frame: 3 moth after injection ]
    Biomarker


Secondary Outcome Measures :
  1. Core Biopsy/Histopathology [ Time Frame: 3 month after injection ]
    Too evaluate histology of keloid

  2. Ultrasonography [ Time Frame: 3 month after injection ]
    To see image inside the body



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326959


Contacts
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Contact: Anastasia Dessy Harsono, Master 087888363270 anastasia.bedahplastik@gmail.com
Contact: Cynthia Retna Sartika, Doctor c.sartika@gmail.com

Sponsors and Collaborators
PT. Prodia Stem Cell Indonesia
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Responsible Party: PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier: NCT04326959    
Other Study ID Numbers: CT/KLD/03/2020
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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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
Keywords provided by PT. Prodia Stem Cell Indonesia:
Keloid
Allogeneic Mesenchymal Stem Cells
Umbilical Cord
Conditioned Medium
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action