First Pilot Study Evaluating the Life Span of Autologous Cultured Red Blood Cells (cRBC) Generated From Peripheral Stem Cells in Three Healthy Volunteers - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Study of the life span in vivo of cultured Red Blood Cells.
研究概览
简要总结
To study the in vivo life span in healthy volunteers of red blood cells generated in vitro from autologous peripheral stem cells. The study will be carried out in 4 phases :
- production in vitro of the equivalent of 1 ml of blood, i.e. 5x10e9 enucleated RBC from mononuclear cells isolated from an HSC graft obtained from a healthy volunteers donor.
- labeling of these cRBC with 51 Cr
- reinjection of the autologous cRBC
- follow up of the receivers for a maximum 33 days to measure the half-life span of the injected cells.
详细描述
- GENERALITIES
1.1 Clinical grade production of cRBC In this study the cRBC is both the active principle and the final product subjected to radioactive chromium labeling.
The quantity of 5x109 cRBC to be reinjected is determined by the necessity to have a quantity of radioactivity lying between 2500 and 5000 kBq in order to have sufficient sensitivity to measure the life span.
1.2 Hypothesis tested Since the cRBC have in vitro all the functional characteristics of native RBC, it is hypothesized that they will be viable in vivo.
This viability will be evaluated by measuring their life span. It will be compared to the reported life span of native RBC, i.e. 30+3 days. 2. OBJECTIVES OF THE STUDY
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aptitude for donation of PSC validated according to the selection criteria for intra-familial donors of hematopoietic stem cells (HSC):
- •Age > 18 years and < 65 years;
- •Search by interview for risk factors pertaining to transmissible diseases;
- •Absence of significant medical antecedents;
- •Absence of severe evolutive pathology (renal, hepatic or cardiac insufficiency);
- •Serological status of the following antibodies (Ab) and antigens (Ag) determined during the 30 days preceding the donation of PSC:
- •anti-HIV 1+2 Ab (2 techniques)
- •P24 antigenemia
- •anti-HCV Ab
- •anti-HBc Ab
- •anti-HBs Ab
- •anti-HTLV I+II Ab
- •anti-CMV Ab
- •anti-toxoplasmosis Ab
- •anti-EBV Ab Determination of the blood group and search for irregular agglutinins (SIA).
- •Presence in addition of the following clinical and biological characteristics required for an assay in a healthy volunteer:
- •Results of the following biological tests within normal limits or clinically acceptable:
- •hemogram,
- •hepatic functions,
- •renal functions;
- •Absence of hemoglobinopathy on the hemoglobin electrophoresis profile;
- •Absence of G6PD or PK deficiency;
- •Absence of a radiological examination in the context of a research protocol within the last 12 months;
- •Normal arterial pressure controlled after 5 min rest in a reclining position: < 140 / 90 in three measurements at 2 min intervals;
- •ECG 12 derivations with no particularity;
- •Signature of a specific statement of informed consent to participate in the study of the life span of cRBC, in addition to the donation of HSC.
排除标准
- •Women of child-bearing age;
- •Donors carrying markers of infection: anti-HIV 1+2 Ab (2 techniques), P24 antigenemia, anti-HCV Ab, HBs Ag, anti-HTLV I+II Ab, syphilis;
- •Hemoglobinopathy;
- •G6PD or PK deficiency;
- •Acute or chronic systemic diseases;
- •Antecedents of hypersensitivity to a drug;
- •Signs, symptoms or results of biological tests lying outside the limits clinically acceptable for healthy subjects;
- •Known allergy to chromium.
研究组 & 干预措施
1
The choice of conducting the study in healthy volunteers and not in patients is based on the necessity to have a healthy physiological context avoiding any situation which could lead to hemolysis. As the protocol requires mobilization with a growth factor, the donors of peripheral stem cells (PSC) receive G-CSF.
Direct intravenous injection of labeled cRBC in a volume of 1 mL will be administered to the subjects.
干预措施: intravenous injection of labeled cRBC (Biological)
结局指标
主要结局
Study of the life span in vivo of cultured Red Blood Cells.
时间窗: At T+24h, T+48h and day 30
次要结局
未报告次要终点