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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05887804
Other study ID # KET-1206
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2021
Est. completion date June 9, 2022

Study information

Verified date June 2023
Source Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Research is directed at studying keloid volume reduction and changes in POSAS score.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 9, 2022
Est. primary completion date June 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.
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.
Drug:
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.

Locations

Country Name City State
Indonesia RSPAD Gatot Soebroto Jakarta Pusat DKI Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Keloid volume reduction Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit 15 weeks
Primary 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. 17 weeks
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