Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05887804
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2023-05-24
Brief 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
Sponsor:
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Organization:
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 cellsmLcm3 group 2 was given umbilical cord-derived conditioned mediumUC-CM 1 mLcm3 and group 3 was given triamcinolone acetonide TA 40 mgmLcm3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None