NCT03509870终止1 期
Uncontrolled Non-randomised Single Dose Study of Topically Applied Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells (REDDSTAR (ORBCEL-M)) in Patients With Non-healing Neuroischaemic Diabetic Foot Wounds'
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- serious adverse events attributable to intervention
研究概览
简要总结
examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers
详细描述
1.1 Trial Phase
Phase 1b
1.2 Trial Aims and Objectives
To examine the safety of topical application of a single dose of allogeneic bone marrow derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.
1.3 Patient Population
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
盲法说明
open
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
- •Age 18-80 years.
- •Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease).
- •HbA1c ≤ 97 mmol/mol (≤ 11%).
- •Males or non-pregnant females.
- •Understand trial information document.
- •Provide written informed consent.
- •Duration of (diabetic foot) wound > 4 but < 52 weeks.
- •Reduction of < 50% area over 4 weeks despite standard care (standard care; off-loading, weekly debridement, dressings, orthotic).
- •Wound area with sharp debridement of ≥ 0.5 but ≤ 4.0 cm
- •Clinically non-infected wound.
- •Texas wound stage 1a, 1c or 2a.
- •Location of wound below malleolus.
- •Affected limb toe pressure ≥ 40 mmHg.
- •An ankle-brachial systolic pressure index between 0.7 and 1.
- •Diagnosis of peripheral neuropathy using American Diabetes Association guidelines (monofilament/vibration sensation/biothesiometer).
- •Able to adhere to study visit protocol.
- •Adhere to offloading devices/orthotic.
排除标准
- •Life expectancy of less than 12 months.
- •Patients with a definite diagnosis of any immunodeficiency disorder.
- •Viral hepatitis [patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)].
- •Active, uncontrolled connective tissue disease.
- •Renal failure as defined by serum creatinine > 220 µmol/L.
- •Liver function tests that are > 2.0 times Upper Limit Normal.
- •Poor nutritional status as measured by serum albumin < 30 g/L.
- •Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).
- •Active wound infection (i.e. recent onset of erythema, oedema, and increased temperature of the foot with normal radiographs).
- •Diabetic Charcot neuroarthropathy or other structural deformity that would prevent adequate off-loading of the study foot.
- •Treatment with any systemic corticosteroid immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity to be treated within 30 days prior to signing the informed consent form.
- •Having received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study.
- •A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance.
- •History of non-compliance with treatment or clinical visit attendance (i.e. this study requires that patients will comply with the protocol and ulcer care regimen).
- •Any unstable medical condition judged by the Principal Investigator that would cause the study to be detrimental to the patient.
- •Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.
- •Wounds with an aetiology not related to diabetes.
- •More than three wounds on the target lower extremity.
- •The wound to be studied not anatomically distinct from another wound(s) (separated by < 1 cm from another wound or would interfere with standard of care treatment of another wound. Only one single wound per one study subject can be treated in this study.
- •Wounds which decrease in area by > 50% during the screening 4-week run-in period.
- •Ulcers with underlying osteomyelitis on the leg with the wound to be treated.
- •Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).
- •Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
- •Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
- •Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.
- •Received dermal substitute or living skin equivalent within 30 days prior to signing the informed consent form.
- •Received prior (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form.
- •Has known history of clinical sensitivity reactions to products of bovine origin or to the primary or secondary dressings used in the trial.
结局指标
主要结局
serious adverse events attributable to intervention
时间窗: 24 weeks
1. Death 2. Septicaemia 3. Amputation of the limb administered with therapy 4. Worsening of the ulcer of the limb administered with therapy 5. Allergic reaction or anaphylaxis 6. Abnormal laboratory results 7. Local or systemic reaction requiring hospital admission
次要结局
- healing(24 weeks)
研究者
研究点 (2)
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