A Phase 4 interventional study of umbilical cord-derived mesenchymal stem cells (UC-MSC) and umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) in Keloid and Stem Cell, sponsored by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto · Phase 4, Interventional, and Treatment
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. Research is directed at studying keloid volume reduction and changes in POSAS score.
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Rumah Sakit Pusat Angkatan Darat Gatot Soebroto is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: umbilical cord-derived mesenchymal stem cells (UC-MSC)
group 2 was given UC-CM 1 mL/cm3
Biological: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
group 3 was given TA 40 mg/mL/cm3
Drug: Triamcinolone Acetonide (TA)
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.
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.
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.
Keloid volume reduction
Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit
Time frame: 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.
Time frame: 17 weeks
Plan to share: No
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Ran from Oct 2021 to primary completion in Jun 2022, 8 months.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Solizmestrocel
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto