Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Interview and visual inspection of ulcers recovery rate
研究概览
简要总结
The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.
详细描述
Under local or general anesthesia, autologous fat will be harvested by using a manual aspiration or syringe-assisted technique. SVF and ASCs isolation from autologous lipoaspirates will be done by enzymatic digestion method (collagenase Type-1 solution for 45 minutes at 37°C). Cell quality assessment will be done prior to transplantation by trypan blue exclusion assay and total populations and fractions of cells identified by immunocytochemistry / flow cytometry. PRP will be derived by centrifugation from 50-100ml blood collected in anticoagulant carrying bag, from patient at the day of transplantation. The injection volume will depend on the wound area of each patient. 2 million cells/ 0.5 ml PRP will be mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone & inside of wound surface bed.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 Diabetes Mellitus
- •Age 20-60 years (Male/Female)
- •Body mass index 20-30 kg/m2
- •Suitable for liposuction
- •Condition or Disease: Diabetic Neuropathy
- •Wound Type: Chronic foot ulcer
- •Approx. wound area: 2 cm2 - 8 cm2
- •Wound Condition should be of Wagner's grade I (Limited to soft tissue)
- •Duration of wound persistence: 6-24 Weeks
- •Transcutaneous oxygen pressure > 30 mmHg, and an ankle brachial pressure index > 0.
- •Already following an adequate off-loading method
- •Provided signed informed consent
排除标准
- •Uncontrolled hyperglycemia (HbAlc > 9%)
- •Presence of severe clinical sign of infection
- •Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.
- •Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases
- •Patients with critical limb ischemia and osteomylitis
- •Withdrawal of informed consent
研究组 & 干预措施
Control; Standard-of-care management
Saline dressing will be done as a routine care management.
干预措施: Control; Standard-of-care management (Other)
Only PRP injection
Only PRP will be injected at the wound site.
干预措施: Only PRP injection (Biological)
PRP + SVF injection
SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.
干预措施: PRP + SVF injection (Biological)
PRP + ASCs injection
Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.
干预措施: PRP + ASCs injection (Biological)
结局指标
主要结局
Interview and visual inspection of ulcers recovery rate
时间窗: 3 months
This will be done in terms of diameter (cm2) of wounds, monitored in both cell transplanted and standard care patients after week interval till 3 months.
次要结局
- Percentages (%) of wound closure rate (with respect to time) will be assessed.(3 months)
研究者
Azra Mehmood
Associate Professor
University of the Punjab