Phase 1/2a Study for Treatment of Chronic Diabetic Foot Ulcers (DFU) With the Investigational Allogeneic Cell Therapy Product, hOMSC200
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cytora Ltd.
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Treatment related adverse events
研究概览
简要总结
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
详细描述
A prospective, placebo controlled, partially blinded and randomized study, comprising two hOMSC200 dose groups (low & high) and one placebo treated group of DFU patients (3 groups; n=8 / treatment groups and n=6/ control group).
Study employs a 2+2 design for dose escalation. The first two patients recruited were treated with a low dose, in a staggered manner, followed by two patients who were recruited to receive the high dose. The remaining patients (18) are randomized to receive the low dose, high dose, or placebo treatment. The assessors and patients will be blinded to the study treatments.
Following administration of hOMSC200 or placebo patients will attend on-site follow up visits for 6 months. During this period safety profile of the investigational product will be assessed as well as measurement of ulcer size. All patients, irrespective of allocated treatment, will receive routine standard of care.
Patients will be followed for long term safety with a phone call interview 1 year following the 6 months termination visit. Optional on-site follow up visits will be offered to all patients during this time period.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Type I or Type 2diabetes and with a neuropathic diabetic foot ulcer for longer than 8 weeks.
- •Size of foot ulcer 0.5-13 cm2
- •Ulcer graded I by Wager scale
- •Ulcer is free of necrotic debris, exhibits no signs of clinical infection
- •Ulcer area blood circulation meets one of the following criteria: A. Palpable tibialis anterior and posterior arteries in the affected foot; B. ABI range >0.7 to <1.3; C. TcPO2>30mmHg
排除标准
- •Ulcer is of non-diabetic pathophysiology
- •The ulcer has decreased in size by >=30% after the screening visit (week -2 to -4 before treatment)
- •Severe hepatic deficiency
- •Glycated hemoglobin A1C (HbA1C) level of >12%
- •Postprandial blood sugar > 350mg/dl
- •Require antibiotics to treat the target wound infection within 14 days prior to treatment
- •Evidence of current wound infection including pus drainage from wound site
- •Severe renal failure (GFR<30) including subject on renal dialysis
- •Pregnant or breastfeeding
- •Was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic agents prior to 4 weeks from screening
- •Patient receiving anticoagulation therapy except for aspirin
- •Underwent wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days prior to screening visit
研究组 & 干预措施
Placebo
Administration of placebo in addition to routine standard of care
干预措施: Placebo (Other)
结局指标
主要结局
Treatment related adverse events
时间窗: 6 months
Occurrence of treatment-related adverse events assessed by common terminology criteria for adverse events (CTCAE) following recruitment, hOMSC200 administration (ID), and during the follow up.
次要结局
- Wound healing(24 weeks)