NCT04104451已完成1 期
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- SAE
研究概览
简要总结
Study Objective:
The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Inclusion Criteria:
- •Males or non-pregnant, non-lactating females.
- •Age 18 or greater at the time of informed consent.
- •Able and willing to provide written informed consent.
- •Type 1 or Type 2 diabetes.
- •Chronic DFU as the index ulcer meeting all of the following criteria:
- •present for at least 4 weeks at the time of Screening Visit 1
- •located below the malleoli of the foot
- •extends to the dermis or subcutaneous tissue, surrounded by healthy skin, without evidence of exposed muscle, tendon, bone, or joint capsule
- •area measures 1 to 10 cm2 inclusive, at Screening Visit 1, and
- •non-healing (defined as ≤50% reduction in ulcer size by the Baseline Visit, as compared to Screening Visit 1).
- •Negative for antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads, within 3 months prior to start of Treatment Phase without interval sensitizing events.
- •For an index ulcer on the plantar surface of the foot, willingness to offload the foot per study protocol.
- •In women of childbearing potential, willingness to use effective means of birth control during the course of the study; if using systemic birth control, this must have been used for 6 months or longer prior to Screening Visit 1.
排除标准
- •Exclusion Criteria:
- •Planned DFU treatment to the index ulcer that includes enzymatic agents, cytotoxic agents or any substance(s) that would affect MSC survival during the study period.
- •Women planning to become pregnant during the course of the study.
- •Significant history of, or current evidence of a severe comorbid medical or psychiatric condition such as liver disease, end-stage renal disease, untreated proliferative retinopathy, bleeding diathesis, schizophrenia, or laboratory abnormality that, in the opinion of the Investigator, would preclude enrollment because of unacceptable risk.
- •Presence of any skin condition or skin disorder around the index ulcer that might interfere with the diagnosis of or assessment of study-related endpoints, such as atopic dermatitis, eczema, psoriasis, or seborrheic dermatitis.
- •Presence of actinic keratosis or skin cancer within 2 cm of the index ulcer.
- •Cellulitis or other active infection of the index ulcer or any non-index ulcer at Screening.
- •Use of an investigational agent for ulcer care within 30 days prior to Screening Visit
- •Receipt of an investigational agent or device not approved by the US FDA for marketed use in any indication within 30 days prior to Screening Visit
- •Planned participation in another therapeutic study for any indication prior to completion of study participation.
- •Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation.
- •Known positivity for Human Immunodeficiency Virus (HIV).
- •Active osteomyelitis or gangrene of either foot at Screening.
- •Known Methicillin-resistant Staphylococcus aureus (MRSA) infection within 30 days prior to Screening Visit
- •Poorly-controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >12%.
- •Unsuitable for cellular therapy for any reason, in the opinion of the Investigator.
- •Planned use of cell therapy or amniotic membrane treatment for the index ulcer during study participation.
- •Significant titer of antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads.
- •Presence of severe peripheral artery disease (PAD) defined as clinical evidence of critical limb ischemia (CLI) during Screening.
研究组 & 干预措施
Dose 1
Experimental
干预措施: Corlicyte (Drug)
Dose 2
Experimental
干预措施: Corlicyte (Drug)
Dose 3
Experimental
干预措施: Corlicyte (Drug)
结局指标
主要结局
SAE
时间窗: throughout study completion, an average of 4 months per subject
Number and percent of subjects in each dosing cohort and overall with a serious adverse reaction to Corlicyte®.
次要结局
- Antibodies to HLA Class I - number and percent(throughout study completion, an average of 4 months per subject)
- Antibodies to HLA Class I - Time To Development(throughout study completion, an average of 4 months per subject)
- Increase Ulcer Size(throughout study completion, an average of 4 months per subject)
- Adverse Reaction(throughout study completion, an average of 4 months per subject)
- Suspected Adverse Reaction(throughout study completion, an average of 4 months per subject)
- Suspected Serious Adverse Reaction(throughout study completion, an average of 4 months per subject)
- Change in A1c(throughout study completion, an average of 4 months per subject)
研究者
研究点 (1)
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