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2017年7月25日

概览

暂无简介。

注册库

who.int

开始日期

2017年7月25日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

extCell Pharma

•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

•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\-