A Pilot Study: Evaluating the Safety and Feasibility of Using Autologous Adipose-Derived Stromal Cells From Stromal Vascular Fraction (SVF) on Adults With Pressure Ulcers or Diabetic Foot Ulcers
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Free of wound infection
研究概览
简要总结
This pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or IV pressure ulcer or diabetic foot ulcers. Patients will undergo a minimal risk liposuction procedure to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and tolerance of the treatment.
详细描述
Wound healing for Stage III and IV pressure ulcers or diabetic foot ulcers can take four to six weeks or longer and cost upwards of $40,000 to treat. Past studies have shown that adipose tissue contains progenitor cells or regenerative cells that can release multiple angiogenic growth factors and cytokines including vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF) and chemokine stromal cell-derived factor-1 (SDF-1). A current literature review revealed that there is research related to use of stem cells to enhance wound healing, in particular with ischemic or radiation-induced ulcers. However, there is limited research completed on use of stem cells or ASCs with pressure ulcers. The goal is to heal pressure ulcers faster and prevent further complications using the patient's own natural ASCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline).
- •Inpatient or outpatient treatment of pressure ulcers
- •Diabetic Foot Ulcer Stage 1 or 2 of any size
- •Co-morbidities may include:
- •Peripheral Vascular Disease (PVD)
- •Coronary Artery Disease (CAD)
- •Chronic Renal Disease (CRD)
- •Chronic Liver Disease (CLD)
- •Hypertension (HTN)
- •The ability of subjects to give appropriate consent or have an appropriate representative available to do so
- •The ability of subjects to return for weekly wound assessments
排除标准
- •Patients with allergies to TISSEEL, Tegaderm, or silicon
- •Diabetics with poor glucose metabolic control (HbA1c > 9)
- •Target wounds that are in close proximity to potential cancerous lesions
- •Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening
- •Wounds located on the face
- •Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers)
- •Wounds caused by diabetes mellitus (diabetic foot ulcers).
- •BMI of <16 Clinical signs of critical colonization or local infection
- •Prolonged (> 6 months) use of steroids
- •Patients on active regimen of chemotherapy
- •Patients receiving radiation in proximity of wound
- •Decompensated chronic liver disease
研究组 & 干预措施
Experimental
Liposuction will be done to extract 50-100 cc of adipose tissue which will be processed to obtain the stromal cells. The adipose-derived stromal cells will be injected into a fibrin sealant applicator and applied to the wound (intervention), Patients will receive 5.0x106 ASCs per cubic centimeter of wound area. The wound will be dressed with an occlusive dressing and soft silicone dressing. The dressing will remain in place for one week (minimally, 3 days). Follow-up will occur weekly for 6 weeks.
干预措施: Adipose-derived stromal cells (Drug)
结局指标
主要结局
Free of wound infection
时间窗: one week
Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor
次要结局
- Liposuction procedure without complication(one week)
- Improved wound healing(weekly observation for 6 weeks)
研究者
Houssam Farres, M.D.
Principal Investigator
Mayo Clinic