Autologous Adipose Derived Stem Cell Transplantation in the Treatment of Keloids. A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Keloids are the most common disfiguring skin disorder affecting colored population with a prevalence of upto 16%.
Autologous adipose derived stem cells have been found to have potential therapeutic benefits however limited clinical trials have compared there role to standard therapy.
This is a pilot study that is intended to evaluate the feasibility of conducting this clinical trial comparing adipose derived stromal vascular fraction to Triamcinolone in keloid treatment. The full clinical trial is already registered under the clinical trial number NCT04391621.
The objective of this Pilot is to evaluate the feasibility of conducting a full study on the same topic.
详细描述
Background: Keloids affect upto 16% of Africans and often demonstrate more aggressive behaviour with poor response to existing therapies.
Adipose derived stem cells have been described to have inhibitory effects on keloid growth with several invitro studies and case series reporting promising findings.
Despite this knowledge, no clinical trial has been conducted to compare the efficacy of these adipose derived stem cells to existing standard therapy. We intend to conduct a clinical trial comparing the adipose derived stem cells to the existing standard of care here in Uganda which is Triamcinolone Acetanoide a trial that is registered under the clinical trial number NCT04391621. Before scaling up this study, we intend to evaluate the feasibility to conducting a full scale study by first piloting the same trial to a smaller number of participants.
The primary objective of this study will be to describe the feasibility and safety of adipose derived stem cells in the treatment of keloids as well as to document the process of autologous adipose derived stem cells harvesting and processing. The secondary outcome will be the clinical endpoints of keloid regression and symptom relief at the end of one month.
This will be a pilot parallel and un-blinded randomised controlled trial that will be conducted at Mulago National Referral Hospital. 6 patients will be allocated randomly into either Triamcinolone group and Adipose Derived Stem cells group. Each arm will receive the respective single dose infiltration of the selected treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a single keloid of 1-2cm3 as these have the highest response to any treatment administered.
排除标准
- •Previous intra-lesional steroid injection treatment in the last three months as the effects may still be ongoing Insufficient abdominal fat pad(depth) of 3cm Confirmed bleeding disorder Ongoing systemic illness Ulceration or local keloid infection
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: three months
Using the Common Terminology Criteria for Adverse events (CTCAE), we shall identify any treatment associated adverse events in both treatment arms and describe the nature and grade of the adverse events.
The procedure time in hours.
时间窗: three months
We intend to evaluate the time it will take to prepare and administer the treatment in both arms. The intervention arm involves three steps which are liposuction, lipo-aspirate processing as well as infiltration. We intend to evaluate the time this will take and compare it to the Active control arm which consists of one step which is the infiltration. This will help answer question on feasibility of performing this procedure as a day care procedure.
次要结局
未报告次要终点