EUCTR2017-002766-50-SE进行中（未招募）1 期
A DOUBLE-BLINDED, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED TRIAL OF WHARTON’S JELLY DERIVED ALLOGENEIC MESENCHYMAL STROMAL CELLS TO PRESERVE ENDOGENOUS INSULIN PRODUCTION IN ADULT PATIENTS DIAGNOSED WITH TYPE 1 DIABETES.
extCell Pharma0 个研究点目标入组 24 人开始时间: 2017年7月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Written informed consent for participation of the study, given before undergoing any study-specific procedures
- •2. Clinical history compatible with type 1 diabetes diagnosed less than 2 years before enrolment
- •3. In the first part of the study patients 1-6 only male patients between 18-40 years of age will be included. In the second part of the study, patients 7-21, both male and female patients 18 to 40 years of age (inclusive at both ends) will be included.
- •4. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol
- •5. Fasting plasma C-peptide concentration >0.12 nmol/L.
- •6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include (in Recommendations related to contraception and pregnancy testing in clinical trials”, supplied from www.hma.eu/):
- •a. Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
- •-intravaginal
- •-transdermal
- •b. progestogen-only hormonal contracption associated with inhibition of ovulation
- •- injectable
- •- implantable
- •c. intrauterine device (IUD)
- •d. intrauterine hormone-releasing system (IUS)
- •e. bilateral tubal occlusion
- •f. total abstinence or vasectomized partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Inability to provide informed consent
- •2. Patients with body mass index (BMI) > 30, or weight >100 kg
- •3. Patients with weight <50 kg
- •4. Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
- •5. Patients with uncontrolled hypertension (=160/105 mmHg).
- •6.Patients with active on-going infections.
- •7. Patients with latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or has travelled in areas with high risk of tuberculosis or mycosis within the last 3 months.
- •8. Patients with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
- •9. Patients with any immune suppressive treatment
- •10. Patients with known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease-
- •11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •11. Patients with known, or previous, malignancy.
- •12. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
- •13. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
- •14. Patients with GFR <80 ml/min/1.73 m2 body surface.
- •15. Patients with proliferative retinopathy
- •16. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
- •17. Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).
研究者
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