NCT01743222已完成1 期
Cx621-0101 Phase I Clinical Trial in Healthy Volunteers to Evaluate the Feasibility and Safety of the Intralymphatic Administration Technique of Expanded Allogeneic Adipose-derived Stem Cells (eASCs)
Tigenix S.A.U.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Local and systemic reaction to administration procedure
研究概览
简要总结
The objective is to determine the safety, tolerability and feasibility of the inguinal intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)
详细描述
Phase I, unicentric, single blind, clinical trial with healthy volunteers to determine the feasibility of a new administration technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 55 both included
- •Inform Consent Form signed
- •Body Mass Index (BMI) between 19 and 29 kg/m2
- •Presence of, at least, one lymph node of 1cm in its larger diameter in each inguinal location. It has to be accessible for administration after its localization using ultrasound scan.
排除标准
- •Pregnant (positive to urine pregnancy test) or breastfeeding women.
- •Subjects with history of any organic or psychic pathology in their records, physical exploration or any complementary test.
- •Any relevant current pathology, including cancer, liver pathology, gastrointestinal dysfunction, renal alteration, respiratory pathology or active acute infectious problems.
- •Chronic disorders or previous recurrent like hypertension, infections, cardiovascular, respiratory, endocrine, neurologic, hematologic, renal or liver disorders.
- •Subjects treated four weeks before the first administration with any drug, medicinal plant or Consumer Health Care in a continue routine. It is not consider exclusion criteria a sporadic medication. The physician will study the interaction between the eASC with this medication.
- •History of hypersensibility to drugs.
- •Volunteers participants in other clinical trial within 4 months prior the start of the study.
- •Blood or derivatives transfusion in 6 months before the trial.
- •Known history of abuse of alcohol or other addictive substances(amount of alcohol allow as maximum in this trial is 0.5 liter of wine or two beers or amount in grams equivalent to this of any other alcoholic drink).
- •Illegal drugs consumption during the month before the enrollment in the study or positive result to a drug test.
- •Positive serology for B hepatitis virus (HbsAg), C hepatitis virus or HIV (Human Inmunodeficiency Virus).
- •Subjects whose freedom depends on legal or administrative requirements.
研究组 & 干预措施
eASC
Experimental
eASC
- First cohort (3 volunteers, first volunteer is not randomized to detect any acute reaction): injection of 2.5 millions of eASCs suspended in 0.25 ml of HTS per lymph node, total dose 5 millions of cells.
- Second cohort (3 volunteers, first volunteer is not randomized to detect any acute reaction): injection of 5 millions of eASCs suspended in 0.5 ml of HTS per lymph node, total dose 10 millions of cells.
干预措施: eASC (Genetic)
Placebo
Placebo Comparator
- First cohort (2 volunteers): injection of 0.25 ml of Hypo Thermosol (HTS) per lymph node
- Second cohort (2 volunteers): injection of 0.5 ml of Hypo Thermosol (HTS) per lymph node
干预措施: Placebo (Drug)
结局指标
主要结局
Local and systemic reaction to administration procedure
时间窗: 29 days
* Pain in administration area will be assessed by a visual analogical scale. * Medical exploration of the administration area will be performed to identify any skin reaction. * Inguinal scan will be performed to assess any lymphatic node modification. * Systemic tolerability will be measured by number of AE (Adverse Event) recorded at any time, including any alteration in laboratory parameters and/or physical exploration.
次要结局
- Pharmacodynamic parameters(29 days)
研究者
研究点 (1)
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