Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Serious adverse reactions
研究概览
简要总结
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.
详细描述
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10.5 ml of normal saline. Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability and sterility assessment. The second portion (10 ml) placed into sterile syringe for injection.
Autologous ADRC administration
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with critical lower limb ischemia, with resting pain wich can't be adequately managed by opioid analgetics and/or foot ulcers or necrosis, with II-4, III-5 и IV-6 stages of chronic arterial failure according to Rutherford's classification
- •Ankle-brachial index less than 0.4 and/or ТСрО2 less than 30 mm Hg
- •Patients with lower limbs' arteries lesions revealed by angiography uneffectiveness or impossibility of limb's revascularisation or patient's refusal of the procedure
- •Patient is familiar with Participant information sheet
- •Patient signed informed consent form
- •Non-inclusion Criteria:
- •Contraindications for local anesthesia or history of allergy for local anesthetics
- •Systemic glucocorticoid and/or immunosuppressant therapy
- •Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)
- •Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- •Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
- •Clinically significant abnormalities in results of laboratory tests
- •Patient received anticoagulants at least 12 hours prior the liposuction
- •Medical history of heterotopic ossifications
- •Patients prescribed for glycoprotein inhibitors treatment
排除标准
- •Patient's refusal from the further participation in trial
- •Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
- •Confirmed syphilis, HIV, hepatitis B or C infections
- •Dropout Criteria:
- •Indications for the amputation of the limb
结局指标
主要结局
Serious adverse reactions
时间窗: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse reactions (SAR)
Serious adverse events
时间窗: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse events (SAE)
次要结局
- Changes of hemodynamics in lower extremity - 2(Follow up to completion (24 weeks after intervention))
- Changes of hemodynamics in lower extremity - 1(Follow up to completion (24 weeks after intervention))
- Quality of life monitoring - 1(Follow up to completion (24 weeks after intervention))
- Changes of ankle-brachial index(Follow up to completion (24 weeks after intervention))
- Metabolic state of targeted tissues measurements(Follow up to completion (24 weeks after intervention))
- Quality of life monitoring - 2(Follow up to completion (24 weeks after intervention))
- Changes of hemodynamics in lower extremity - 3(Follow up to completion (24 weeks after intervention))