- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326959
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid (Keloid)
July 14, 2020 updated by: PT. Prodia Stem Cell Indonesia
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anastasia Dessy Harsono, Master
- Phone Number: 087888363270
- Email: anastasia.bedahplastik@gmail.com
Study Contact Backup
- Name: Cynthia Retna Sartika, Doctor
- Email: c.sartika@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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 Names:
|
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.
|
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 Names:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alfa SMA-1
Time Frame: 3 month after injection
|
Biomarker
|
3 month after injection
|
Collagen type 1
Time Frame: 3 moth after injection
|
Biomarker
|
3 moth after injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core Biopsy/Histopathology
Time Frame: 3 month after injection
|
Too evaluate histology of keloid
|
3 month after injection
|
Ultrasonography
Time Frame: 3 month after injection
|
To see image inside the body
|
3 month after injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
September 8, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
July 15, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Connective Tissue Diseases
- Fibrosis
- Cicatrix
- Collagen Diseases
- Keloid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- CT/KLD/03/2020
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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