ISRCTN37116985已完成1 期
Therapy of type 1 diabetes with ex-vivo expanded CD4+CD25+CD127- T regulatory cells (Tregs) and anti-CD20 monoclonal antibody – a randomized trial
Gdansk Medical University0 个研究点目标入组 45 人开始时间: 2021年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
2022 Abstract results in https://doi.org/10.1111/dom.14723 (added 21/04/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 8 to 16 years of age
- •2. BMI in the range of 25-75 percentiles (according to OLAF)
- •3. Fasting plasma C-peptide more than 0.7 ng/ml and in a stimulation test the increase is =100%
- •4. The presence of anti-islet autoantibody (ICA, IAA, GAD) - high titer one of the antibodies (=4 times the norm, not applicable ICA) or low titer of two or three antibodies (2-4 times the norm)
- •5. Ability to provide written informed consent by parents (and patients if above 16 years old)
- •6. Involvement of the patients and parents in the intensive diabetes management defined as self-monitoring of glucose values no less than three times per day and by the administration of insulin
- •7. Appropriate venous access for blood drawing
排除标准
- •1. No agreement for participation in the study and no informed consent signed
- •2. Other than autoimmune type 1 diabetes
- •3. Age below 8 and above 16 years
- •4. IgA deficiency or other genetic defect present
- •5. BMI <25 or >75 percentiles for a particular age
- •6. Hypersensitivity to anti-CD20 or other components of the preparation
- •7. Presence or history of active infection including hepatitis B, hepatitis C, HIV, tuberculosis (TB) or syphilis. Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection
- •8. Presence of active EBV virus infection (positive IgM)
- •9. Presence or history of active systemic fungal infection
- •10. Any history of malignancy
- •11. Anemia, lymphopenia, neutropenia or thrombocytopenia below the lower limits of the reference range during the 6 weeks before study
- •12. Known hypercoagulative state
- •13. Medical treatment requiring chronic use of drugs other than insulin longer than 3 months
- •14. Treatment with any anti-diabetic medication other than insulin within 4 weeks of enrolment
- •15. Diabetic retinopathy
- •16. Arterial hypertension
- •17. Presence or history of macroalbuminuria
- •18. For female subjects older than 15 years positive pregnancy test, unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation, when appropriate
- •19. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation when appropriate
- •20. Excessive anxiety of the patient or parents related to the procedures
- •21. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial
- •22. For parents and children older than 15 years: known active alcohol or substance abuse
研究者
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