KeloidPhase 4NCT05887804

Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial

A Phase 4 study testing umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) and Triamcinolone Acetonide (TA) in people with Keloid and Stem Cell, run by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a double-blind randomized controlled trial (RCT) examining the effect of intralesional injection of umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) on keloids carried out using CONSORT statement. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Keloid, Stem Cell
What is being tested?: umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) and Triamcinolone Acetonide (TA)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteIndonesia
Study dates: 1 Oct 2021to 9 Jun 2022
Phase: Phase 4
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
No healthy volunteers
Adult

Who may be able to join

The patient has keloids with a length of 2-10 cm and a thickness of 3-5 mm located on the chest, back, abdomen and extremities
Patients aged 18 - 55 years
Post-surgery patients more than 3 months that cause keloids
The patient is willing to fill in the informed consent form

Who cannot join

Patients with hypertrophic scars
History of kidney failure
Hypertension
Pregnant and breastfeeding
History of blood disorders
History of tumor or malignancy
Get other keloid therapy outside of the research procedure

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

RSPAD Gatot Soebroto
Jakarta Pusat, DKI Jakarta, 10410

Other trials in Indonesia

About this study

Read the detailed description

Patients were screened initially by measuring the length and thickness of the keloids using a ruler. Patients who met the study inclusion criteria were randomly divided into three groups. Each patient in the groups was given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure. Group 1 was given umbilical cord-derived mesenchymal stem cells (UC-MSC) 2 million cells/mL/cm3, group 2 was given umbilical cord-derived conditioned medium(UC-CM) 1 mL/cm3, and group 3 was given triamcinolone acetonide (TA) 40 mg/mL/cm3. All patients received a single dose and 1 booster dose. The percentage of keloid volume regression in each treatment group was calculated by calculating the difference in volume before and after therapy with a 3-dimensional CT-scan, then expressed as a percentage. The CT-scan volume was obtained with the SmartVitrea application (Figure 2), then a POSAS examination will be carried out for subjective and objective assessment.

Conditions: Keloid, Stem Cell
Being tested: umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM), Triamcinolone Acetonide (TA)
Keywords: Keloid therapy, mesenchymal stem cells, keloid volume, POSAS
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-derived mesenchymal stem cells (UC-MSC)Biological
Group 1 was injected UC-MSC 2 million cells/mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)Biological
Group 2 was injected UC-CM 1 mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.
Triamcinolone Acetonide (TA)Drug
Group 3 was injected TA 40 mg/mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.

Study groups in NCT05887804
Study group	Role	What they receive
umbilical cord-derived mesenchymal stem cells (UC-MSC)	Experimental	UC-MSC was collected in 50 mL of transport medium, which contained alpha minimal essential medium (αMEM [GIBCO 12000-0221]), penicillin/streptomycin (final concentration 300u/mL [GIBCO 15140-122]) and amphotericin B (final concentration 7500ng /mL [JR Scientific 50701]), and processed in less than 8 hours after collection. Group 1 was given UC-MSC 2 million cells/mL/cm3 Receives: Biological: umbilical cord-derived mesenchymal stem cells (UC-MSC)
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)	Experimental	group 2 was given UC-CM 1 mL/cm3 Receives: Biological: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
triamcinolone acetonide	Active comparator	group 3 was given TA 40 mg/mL/cm3 Receives: Drug: Triamcinolone Acetonide (TA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Keloid volume reduction
Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit
Measured: 15 weeks
The Patient and Observer Scar Assessment Scale (POSAS) score reduction
Symptoms were measured using The Patient and Observer Scar Assessment Scale (POSAS) on the first visit, five weeks, 13 weeks, and 17 weeks after the first visit. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', corresponding to the normal skin situation (i.e., normal pigmentation, no itching). Score 10 equals the most significant difference from normal skin (i.e., the worst imaginable scar or sensation). The symptoms are considered improved if the score gets lower. The total score of both scales can be calculated by summing up the scores of each of the six items. The total score can range from 6 to 60.
Measured: 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20219 Jun 2022

First posted5 Jun 2023
Study start1 Oct 2021
Primary completion9 Jun 2022
Study completion9 Jun 2022

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients were screened initially by measuring the length and thickness of the keloids using a ruler. Patients who met the study inclusion criteria were randomly divided into 3 groups. Each patient in the groups was given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure. Group 1 was given UC-MSC 2 million cells/mL/cm3, group 2 was given UC-CM 1 mL/cm3, and group 3 was given TA 40 mg/mL/cm3.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05887804
Sponsor's protocol ID: KET-1206
Status last verified: Jun 2023
First submitted: 24 May 2023
Last updated: 7 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Keloid trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial
ClinicalTrials.gov ID: NCT05887804
Acronym / sponsor ID: KET-1206
Conditions: Keloid, Stem Cell
Keywords: Keloid therapy, mesenchymal stem cells, keloid volume, POSAS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Rumah Sakit Pusat Angkatan Darat Gatot SoebrotoUniversity, hospital or other
Collaborators: Universitas Indonesia
Study start: 1 Oct 2021 (actual)
Primary completion: 9 Jun 2022 (actual)
Study completion: 9 Jun 2022 (actual)
First posted: 5 Jun 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Patients were screened initially by measuring the length and thickness of the keloids using a ruler. Patients who met the study inclusion criteria were randomly divided into 3 groups. Each patient in the groups was given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure. Group 1 was given UC-MSC 2 million cells/mL/cm3, group 2 was given UC-CM 1 mL/cm3, and group 3 was given TA 40 mg/mL/cm3.

Arm	Type	Receives
umbilical cord-derived mesenchymal stem cells (UC-MSC)	Experimental	Biological: umbilical cord-derived mesenchymal stem cells (UC-MSC)UC-MSC was collected in 50 mL of transport medium, which contained alpha minimal essential medium (αMEM [GIBCO 12000-0221]), penicillin/streptomycin (final concentration 300u/mL [GIBCO 15140-122]) and amphotericin B (final concentration 7500ng /mL [JR Scientific 50701]), and processed in less than 8 hours after collection. Group 1 was given UC-MSC 2 million cells/mL/cm3
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)	Experimental	Biological: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)group 2 was given UC-CM 1 mL/cm3
triamcinolone acetonide	Active comparator	Drug: Triamcinolone Acetonide (TA)group 3 was given TA 40 mg/mL/cm3

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

The patient has keloids with a length of 2-10 cm and a thickness of 3-5 mm located on the chest, back, abdomen and extremities
Patients aged 18 - 55 years
Post-surgery patients more than 3 months that cause keloids
The patient is willing to fill in the informed consent form

Key exclusion criteria (7 listed)

Patients with hypertrophic scars
History of kidney failure
Hypertension
Pregnant and breastfeeding
History of 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-derived mesenchymal stem cells (UC-MSC)Group 1 was injected UC-MSC 2 million cells/mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.	Biological	umbilical cord-derived mesenchymal stem cells (UC-MSC)
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)Group 2 was injected UC-CM 1 mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.	Biological	umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
Triamcinolone Acetonide (TA)Group 3 was injected TA 40 mg/mL/cm3, given the same injection volume (1 mL) in every cm3 keloid volume using a 1 mL syringe and 27G needle. The injections were ultrasound-guided into the center of the lesion with a 30-45-degree angle using an in-plane technique, therefore the same pressure.	Drug	triamcinolone acetonide

Primary outcome

Keloid volume reduction
Time frame: 15 weeks
Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit
The Patient and Observer Scar Assessment Scale (POSAS) score reduction
Time frame: 17 weeks
Symptoms were measured using The Patient and Observer Scar Assessment Scale (POSAS) on the first visit, five weeks, 13 weeks, and 17 weeks after the first visit. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', corresponding to the normal skin situation (i.e., normal pigmentation, no itching). Score 10 equals the most significant difference from normal skin (i.e., the worst imaginable scar or sensation). The symptoms are considered improved if the score gets lower. The total score of both scales can be calculated by summing up the scores of each of the six items. The total score can range from 6 to 60.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Individual participant dataSharing planned: No

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
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RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Keloid volume reduction (time frame: 15 weeks). 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?

On the ClinicalTrials.gov record for NCT05887804.

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 7 Jun 2023.