A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers
试验速览
- 阶段
- 3 期
- 入组人数
- 252
- 试验地点
- 28
- 主要终点
- Time to complete closure of Target Ulcer
研究概览
简要总结
The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ankle Brachial Pressure Index (ABI) ≥ 0.80
- •Venous insufficiency confirmed by duplex Doppler ultrasound
- •Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit
排除标准
- •Target Ulcer has decreased >30% in size from Screening to Baseline
- •Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit.
- •Patients who are unable to tolerate multi-layer compression therapy.
- •Ulcer, which in the opinion of the Investigator is suspicious for cancer.
- •Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
- •History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit.
- •Patients with clinically significant claudication
- •Current sepsis
- •Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV
研究组 & 干预措施
CureXcell®
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
干预措施: CureXcell® (Biological)
Placebo injection
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
干预措施: Placebo injection (Other)
结局指标
主要结局
Time to complete closure of Target Ulcer
时间窗: up to 16 weeks
Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
次要结局
- Proportion of complete closure of Target Ulcer(up to 16 weeks)
- Percentage change from baseline in Target Ulcer surface area(up to 12 weeks)
- Proportion of Target Ulcer recurrence(up to 24 weeks)