Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2
试验速览
- 阶段
- 1 期
- 入组人数
- 51
- 主要终点
- Wound size change
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. A third of the participants will receive dac-MSCs and Triticum vulgare (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and the last third only Fitosimoline. This study will be a randomized, blind, and parallel and controlled-group trial.
详细描述
Conventional treatments such as dry, wet or active dressings are effective only in 50% of patients with diabetic foot ulcer. The remaining 50% of patients have non-responding recoveries that leads to amputation of the compromised limbs. Currently, the administration of mesenchymal stem cells (MSCs) in animal models or in small groups of patients with diabetic foot ulcer has shown to be safe and effective. Particularly, the use of these cells induce regeneration, both in the dermis and the epidermis. Nevertheless, MSC transplantation has some limitations, for instance, time restrictions in the availability of cells due to their isolation and expansion as well as the complex and costly large-scale production. In the same manner, the cryopreservation might cause deleterious effects that affect the biological activity of the cells and a medical professional should conduct the cell administration. In addition, different studies report variability in the results due to the inconsistency in the methods that they used (extraction protocols, cultivation, expansion and administration). The investigators' recent studies in mice with skin lesions, particularly type 1 diabetes, have shown that the presence of the cells is not necessary to promote skin regeneration and the administration of dac-MSCs is sufficient to stimulate would healing.
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
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages of 40 and 80 years, inclusive, with Type 1 or 2 diabetes as defined by the American Diabetes Association
- •Stable glycemic control
- •Transcutaneous oxygen measurement > 30 mmHg
- •Ulcer present at least for 1 month
- •Wound size between 0.5 and 5 cm2
- •Subjects that require endovascular surgical intervention
- •Subjects must have adequate nutrition (albumin level > 2 g/dL and prealbumin level > 15 mg/dL)
排除标准
- •Previous or current diagnoses with one of the following: cancer, symptomatic coronary artery disease, brain disease, kidney failure, blood disorders
- •Taking immunosuppressive and cytotoxic drugs
- •Presence of active systemic infection
研究组 & 干预措施
Fitostimoline
Topical application of fitostimoline every other day
干预措施: Fitostimoline (Drug)
dac-MSCs and Fitostimoline
Intradermic application of dac-MSCs (1 mL ) in four equidistant points around the ulcer (twice: day 0 and 7) and topical application of fitostimoline every other day
干预措施: dac-MSCs (Other)
dac-MSCs and Fitostimoline
Intradermic application of dac-MSCs (1 mL ) in four equidistant points around the ulcer (twice: day 0 and 7) and topical application of fitostimoline every other day
干预措施: Fitostimoline (Drug)
MSCs and Fitostimoline
Intradermic application of MSCs (500,000 cells/mL) in four equidistant points around the ulcer (once: day 0 ) and topical application of fitostimoline every other day
干预措施: MSCs (Other)
MSCs and Fitostimoline
Intradermic application of MSCs (500,000 cells/mL) in four equidistant points around the ulcer (once: day 0 ) and topical application of fitostimoline every other day
干预措施: Fitostimoline (Drug)
结局指标
主要结局
Wound size change
时间窗: One year
Wound size will be assessed using a SilhouetteMobile camera (digital planimetry)
次要结局
- Pigmentation change(One year)
- Granulation tissue percentage(One year)
- Presence of Exudate(One year)
研究者
Claudia Lucia Sossa Melo
Associate Professor
Universidad Autónoma de Bucaramanga
