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临床试验/NCT02943486
NCT02943486Unknown1 期

Mesenchymal Stromal Cell Derivatives: a New Alternative and Potential Product for the Treatment of Diabetic Foot Ulcers 1 and 2

Universidad Autónoma de Bucaramanga0 个研究点目标入组 51 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Topical application of fitostimoline every other day

干预措施: Fitostimoline (Drug)

dac-MSCs and Fitostimoline

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Lucia Sossa Melo

Associate Professor

Universidad Autónoma de Bucaramanga

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