ISRCTN06128462已完成不适用
Cellular therapy of type 1 diabetes with ex vivo expanded CD4+CD25+CD127- T regulatory cells
Medical University of Gdansk (Poland)0 个研究点目标入组 20 人开始时间: 2013年9月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •TREGS STUDY ARM
- •1. Male and female patients 5 to 18 years of age.
- •2. Ability to provide written informed consent by parents (and patients if above 16years old)
- •3. Clinical history ofautoimmune type 1 diabetes diagnosed within recent 2 months and presence of at least one type of anti-islet autoantibody: antiGAD, antiIA2, IAA, ICA (high titer).
- •4. Fasting plasma C-peptide more than 0.4ng/mL
- •5. Involvement of the patients and parents in the intensive diabetes management defined as self monitoring of glucose values no less than three times/ day and by the administration of insulin injections each day or insulin pump therapy.
- •6. Patient and parents mentally stable and able to comply with the procedures of the study protocol.
- •7. Appropriate venous access for blood drawing.
- •CONTROL GROUP ARM :
- •1. Patients fulfilling the inclusion criteria from 1 to 6 but
- •2. EXCLUDED from blood drawing due to inappropriate venous access.
排除标准
- •1. No agreement for participation in the study and no inform consent singed
- •2. Other than autoimmune type 1 diabetes
- •3. Age below 5 and above 18 years at the time of recruitment
- •4. Carriage of HLA-DQB1*0602 allele
- •5. IgA deficiency or other genetic defect present
- •6. Body mass index (BMI) outside the range of 25-75 percentiles for a particular age.
- •7. Presence or history of active infection including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection.
- •8. Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment.
- •9. Any history of malignancy
- •10. Baseline Hb below the lower limits of the reference range ; lymphopenia (11. Known hypercoagulative state.
- •12. Medical treatment requiring chronic use of drugs other than insulin
- •13. Treatment with any anti-diabetic medication other than insulin within 4 weeks of enrolment (special attention to exclude anti-CD3 treated patients).
- •14. Diabetic retinopathy.
- •15. Arterial hypertension.
- •16. Presence or history of macroalbuminuria (>300 mg/g creatinine).
- •17. 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. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception when appropriate.
- •18. Excessive anxiety of the patient or parents related to the procedures.
- •19. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
- •20. For parents and children older than 15 years: known active alcohol or substance abuse.
研究者
相似试验
已完成
1 期
Therapy of type 1 diabetes with T regulatory cells and anti-CD20 monoclonal antibodyType 1 diabetes mellitusType 1 diabetesISRCTN37116985Gdansk Medical University45
招募中
不适用
Beta cell regeneration therapy for type 1 diabetes by GLP-1 receptor agonist and insulitype 1 diabetesJPRN-UMIN000006088Department of Metabolic Medicine, Graduate School of Medicine, Osaka University24
进行中（未招募）
1 期
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem CellsDiabetes Mellitus, Type 1NCT04061746Medical University of South Carolina60
尚未招募
不适用
In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?Metabolic and Endocrine - DiabetesType 1 diabetesACTRN12615000666527John Hunter Children's Hospital10
终止
2 期
Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 DiabetesDiabetes Mellitus Type 1Autoimmune DiabetesNCT00837759National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)7