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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Keloid volume reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The laboratory staff prepared the substances in identical syringes without informing the researchers according to randomization. Data processing was carried out by statisticians and clinicians other than researchers.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: umbilical cord-derived mesenchymal stem cells (UC-MSC) (Biological)
umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM)
group 2 was given UC-CM 1 mL/cm3
干预措施: umbilical cord-derived mesenchymal stem cells conditioned medium (UC-CM) (Biological)
triamcinolone acetonide
group 3 was given TA 40 mg/mL/cm3
干预措施: Triamcinolone Acetonide (TA) (Drug)
结局指标
主要结局
Keloid volume reduction
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点