KeloidPhase 4NCT05939817
The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: 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.
Trial summary
The objective of this study is to observe the potency of umbilical cord-derived mesenchymal stem cells (UC-MSC) and umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) in keloid therapy, measured by the decrease in the type 1:3 collagen ratio and the increase of IL-10 levels carried out… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- 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.
About this study
The objective of this study is to observe the potency of umbilical cord-derived mesenchymal stem cells (UC-MSC) and umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) in keloid therapy, measured by the decrease in the type 1:3 collagen ratio and the increase of IL-10 levels carried out using CONSORT statement.
Read the detailed description
Screening of patients were done by measuring keloid dimensions using a ruler. Patients meeting the inclusion criteria were then randomly divided into 3 groups. The same injection volume (1 ml) in every cm3 keloid volume was given using a 1 mL syringe and 27G needle to the subjects. Ultrasound guidance was used to administer the injection using an in-plane technique into the center of the lesion, with inclinations of 30-45 degrees, ensuring uniform pressure in every subject. Group 1 was given UC-MSC 2 million cells/mL/cm3, group 2 receives UC-CM 1mL/cm3 while group 3 was administered TA 40 mg/mL/cm3. In order to obtain UC-MSC and UC-CM, 10 cm of umbilical cord tissue was collected in 50 mL transport medium containing the following substances: amphotericin B (Final concentration 7500 ng/ml [JR Scientific 50701]), alpha minimal essential medium (MEM [GIBCO 12000-022 1]), penicillin/streptomycin (final concentration 300 U/ml [Gibco 15140-122]). Samples were then processed within 8 hours of collection. The umbilical cord was then dissected, briefly washed in 0.5% povidone-iodine (betadine ©) with phosphate buffered saline of pH 7.4 (PBS [Sigma P3813]), and then washed in PBS to remove betadine and blood. The umbilical vessels were excised before the umbilical cord was minced into a complete medium. UC-CM was created using Alpha-MEM and Dulbecco's modified Eagles medium (DMEM [GIBCO 31600-034]). The finalized complete medium contains 1% L-glutamine (Lonza 17-605C), 10% TC (Indonesian Red Cross), amphotericin B (final concentration 2500 ng/ml), and penicillin/streptomycin (final concentration 100 U/ml). Supplementation of culture with 10% autologous or allogeneic cord blood serum and 10% human AB serum (Gibco 34005-100) was done to create MEM. Each well of a 12-well plate (growth are 3.8 cm2 [Biolite]) was filled with three explants (diameter 2-5 mm) and Wharton's Jelly, followed by addition of several drops of complete medium. Triplication of culture was done to each medium. The plate was incubated at 37°C and 5% CO2 and observed daily for contamination or cellular growth, in which the contaminated wells were removed. After the explants was attached, addition of 200-500 µL of appropriate medium was done. Medium changes, involving removal of half of the medium and addition of half of each medium, were performed every 2-3 days. Growth of the cells beyond the explants with 90% confluence marks viability for harvesting using TrypLE Select (GIBCO 12563-011). Dye exclusion method was used to count the viable/non-viable cell yield. After each harvest, with the explant still attached to the plate, new appropriate medium was added with the plate being re-incubated at 37°C and 5% CO2. Similar treatment was repeated for the second and subsequent cultures, enabling multiple harvests from a single explant. Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination are Sirius red staining to evaluate collagen structure under a polarizing lens, as well as In Vitro quantitative examination using the ELISA method to examine IL-10. Calculation of changes in the ratio of type 1 to type 3 collagen levels was carried out by dividing the ratio of collagen before treatment from the ratio of collagen after each treatment. When visualized under a polarizing lens, type-3 collagen will appear green-birefringence and type-1 collagen will appear yellow-birefringence. The collagen ratio was obtained by dividing the composition of collagen type 1 to collagen type 3 in Sirius red staining under polarizing lenses.
- 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, Interleukin-10, collagen ratio
- 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 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.
Type 1:3 collagen ratio reduction
Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination are Sirius red staining to evaluate collagen structure under a polarizing lens. Calculation of changes in the ratio of type 1 to type 3 collagen levels was carried out by dividing the ratio of collagen before treatment from the ratio of collagen after each treatment. When visualized under a polarizing lens, type-3 collagen will appear green-birefringence and type-1 collagen will appear yellow-birefringence. The collagen ratio was obtained by dividing the composition of collagen type 1 to collagen type 3 in Sirius red staining under polarizing lenses.
Measured: 17 weeks
IL-10 levels increase
Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination is In Vitro quantitative examination using the ELISA method to examine IL-10.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 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)
Sponsor and investigators
- Lead sponsor
- Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939817
- Sponsor's protocol ID
- KET-1206/UN2.F1
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05939817
- Acronym / sponsor ID
- KET-1206/UN2.F1
- Keywords
- Keloid therapy, mesenchymal stem cells, Interleukin-10, collagen ratio
- 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
- 11 Jul 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.
The objective of this study is to observe the potency of umbilical cord-derived mesenchymal stem cells (UC-MSC) and umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) in keloid therapy, measured by the decrease in the type 1:3 collagen ratio and the increase of IL-10 levels carried out using CONSORT statement.
Detailed description
Screening of patients were done by measuring keloid dimensions using a ruler. Patients meeting the inclusion criteria were then randomly divided into 3 groups. The same injection volume (1 ml) in every cm3 keloid volume was given using a 1 mL syringe and 27G needle to the subjects. Ultrasound guidance was used to administer the injection using an in-plane technique into the center of the lesion, with inclinations of 30-45 degrees, ensuring uniform pressure in every subject. Group 1 was given UC-MSC 2 million cells/mL/cm3, group 2 receives UC-CM 1mL/cm3 while group 3 was administered TA 40 mg/mL/cm3. In order to obtain UC-MSC and UC-CM, 10 cm of umbilical cord tissue was collected in 50 mL transport medium containing the following substances: amphotericin B (Final concentration 7500 ng/ml [JR Scientific 50701]), alpha minimal essential medium (MEM [GIBCO 12000-022 1]), penicillin/streptomycin (final concentration 300 U/ml [Gibco 15140-122]). Samples were then processed within 8 hours of collection. The umbilical cord was then dissected, briefly washed in 0.5% povidone-iodine (betadine ©) with phosphate buffered saline of pH 7.4 (PBS [Sigma P3813]), and then washed in PBS to remove betadine and blood. The umbilical vessels were excised before the umbilical cord was minced into a complete medium. UC-CM was created using Alpha-MEM and Dulbecco's modified Eagles medium (DMEM [GIBCO 31600-034]). The finalized complete medium contains 1% L-glutamine (Lonza 17-605C), 10% TC (Indonesian Red Cross), amphotericin B (final concentration 2500 ng/ml), and penicillin/streptomycin (final concentration 100 U/ml). Supplementation of culture with 10% autologous or allogeneic cord blood serum and 10% human AB serum (Gibco 34005-100) was done to create MEM. Each well of a 12-well plate (growth are 3.8 cm2 [Biolite]) was filled with three explants (diameter 2-5 mm) and Wharton's Jelly, followed by addition of several drops of complete medium. Triplication of culture was done to each medium. The plate was incubated at 37°C and 5% CO2 and observed daily for contamination or cellular growth, in which the contaminated wells were removed. After the explants was attached, addition of 200-500 µL of appropriate medium was done. Medium changes, involving removal of half of the medium and addition of half of each medium, were performed every 2-3 days. Growth of the cells beyond the explants with 90% confluence marks viability for harvesting using TrypLE Select (GIBCO 12563-011). Dye exclusion method was used to count the viable/non-viable cell yield. After each harvest, with the explant still attached to the plate, new appropriate medium was added with the plate being re-incubated at 37°C and 5% CO2. Similar treatment was repeated for the second and subsequent cultures, enabling multiple harvests from a single explant. Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination are Sirius red staining to evaluate collagen structure under a polarizing lens, as well as In Vitro quantitative examination using the ELISA method to examine IL-10. Calculation of changes in the ratio of type 1 to type 3 collagen levels was carried out by dividing the ratio of collagen before treatment from the ratio of collagen after each treatment. When visualized under a polarizing lens, type-3 collagen will appear green-birefringence and type-1 collagen will appear yellow-birefringence. The collagen ratio was obtained by dividing the composition of collagen type 1 to collagen type 3 in Sirius red staining under polarizing lenses.
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
Type 1:3 collagen ratio reduction
Time frame: 17 weeks
Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination are Sirius red staining to evaluate collagen structure under a polarizing lens. Calculation of changes in the ratio of type 1 to type 3 collagen levels was carried out by dividing the ratio of collagen before treatment from the ratio of collagen after each treatment. When visualized under a polarizing lens, type-3 collagen will appear green-birefringence and type-1 collagen will appear yellow-birefringence. The collagen ratio was obtained by dividing the composition of collagen type 1 to collagen type 3 in Sirius red staining under polarizing lenses.
IL-10 levels increase
Time frame: 17 weeks
Biopsies of the keloid tissues were then conducted twice, in the first meeting and 17 weeks after. Parameters to be evaluated in anatomic pathology examination is In Vitro quantitative examination using the ELISA method to examine IL-10.
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 11 Jul 2023.
- Individual participant dataSharing planned: No
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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?
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.
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 11 Jul 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?
Type 1:3 collagen ratio reduction (time frame: 17 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?
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 11 Jul 2023.