KeloidPhase 1/2KeloidNCT04326959
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
A Phase 1/2 study testing Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium, Conditioned Medium and Triamcinolone Acetonide in people with Keloid, run by PT. Prodia Stem Cell Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Keloid
- What is being tested?
- Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium, Conditioned Medium and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Surgery history of more than 3 months
- Has keloid that the maximum size is 15 cm and thickness is 3-5 mm
Who cannot join
- Patients with kidney failure
- Pregnancy
- Breastfeeding
- Liver dysfunction
- Blood disorders
- Currently receiving immunosuppressant therapy (chemotherapy or steroids)
- Refusing to participate in the study
Trial locations and contacts
No sites are listed yet.
Cynthia Retna Sartika, Doctor contact
About this study
Official title: 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.
- Conditions
- Keloid
- Being tested
- Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium, Conditioned Medium, Triamcinolone Acetonide
- Keywords
- Keloid, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conditioned MediumBiological
Also called Secretome
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium; Biological: 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. Receives: 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. Receives: Biological: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alfa SMA-1
Biomarker
Measured: 3 month after injection
Collagen type 1
Biomarker
Measured: 3 moth after injection
Secondary outcomes (2)
Core Biopsy/Histopathology
Too evaluate histology of keloid
Measured: 3 month after injection
Ultrasonography
To see image inside the body
Measured: 3 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion8 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326959
- Sponsor's protocol ID
- CT/KLD/03/2020
- Acronym
- Keloid
- Status last verified
- Jul 2020
- First submitted
- 26 Mar 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
- ClinicalTrials.gov ID
- NCT04326959
- Acronym / sponsor ID
- Keloid / CT/KLD/03/2020
- Conditions
- Keloid
- Keywords
- Keloid, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 8 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs + CM | Experimental | Biological: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium, Biological: Conditioned MediumA 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. |
| CM + CM | Experimental | Biological: Conditioned MediumA 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. |
| Triamcinolon acetonide | Experimental | Biological: Triamcinolone AcetonideA 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Surgery history of more than 3 months
- Has keloid that the maximum size is 15 cm and thickness is 3-5 mm
Key exclusion criteria (7 listed)
- Patients with kidney failure
- Pregnancy
- Breastfeeding
- Liver dysfunction
- Blood disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord-Mesenchymal Stem Cells and Conditioned MediumInjection 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 | UC-MSCs + CM |
| Conditioned MediumAlso: SecretomeInjection 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. | Biological | CM + CM, UC-MSCs + CM |
| Triamcinolone AcetonideInjection 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. | Biological | Triamcinolon acetonide |
Primary outcome
Alfa SMA-1
Time frame: 3 month after injection
Biomarker
Collagen type 1
Time frame: 3 moth after injection
Biomarker
2 secondary outcomes
Core Biopsy/Histopathology
Time frame: 3 month after injection
Ultrasonography
Time frame: 3 month after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Related trials for Keloid
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloid
Recruiting
Radiotherapy for Keloids
Keloid
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Retna Sartika, Doctor contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium, Conditioned Medium and Triamcinolone Acetonide in people with Keloid, run by PT. Prodia Stem Cell Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Dessy Harsono, Master (087888363270, anastasia.bedahplastik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alfa SMA-1 (time frame: 3 month after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.