NL-OMON50354招募中不适用
Immune intervention with tolerogenic dendritic cells in type 1 diabetes. A phase 1 safety study called D-sense - D-sense
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18-45 years;
- •Diagnosis of T1D at least 18 months dated from the first insulin injection
- •Adequate self-assessment of blood glucose values, and recording of glucose
- •values and administered insuline doses as deemed sufficient by the patient*s
- •Stable glycemic control according to the patient*s physician
- •Possession of *0401 allele at the HLA-DRB1 gene locus;
- •Written informed consent.
- •Pregnancies during the study must be prevented both by female participant and
- •in case of male participants by them or their partners.
排除标准
- •Use of immunosuppressive or immunomodulatory therapies, including systemic
- •steroids within 1 month prior to enrolment and/or prior monoclonal antibody
- •therapy of any type given for any indication at any time;
- •Use of beta-cell stimulants (e.g. sulphonylureas), glucagon-like peptide-1
- •agonists, dipeptidyl peptidase-IV inhibitors, insulin sensitizers (e.g.
- •metformin, thiazolidinediones)
- •Immunisation with live or killed vaccines or allergic desensitization
- •procedures less than 1 month prior to enrolment;
- •History of disease associated with autoimmunity or inflammatory disorders
- •other than T1D;
- •History of malignancy;
- •Male or female patients who are fertile and are unwilling to use adequate
- •contraception at least 3 months prior to the first administration of
- •PIpepTolDCs until at least 60 days following the last administration of
- •PIpepTolDCs;
- •Recent (< 3 months) HbA1c > 64 mmol/ mol.
- •Lack of beta-cell autoantibodies (eligible autoantibodies: GADA or dIA-2A)
- •Low vitamin D25 (OH) (<50 nmol/l) and/or 1,25 (OH)2 Vitamin D levels (< 40
- •pmol/l) at PIpepTolDCs injections
- •Female patients who are pregnant or breastfeeding;
- •Recent patient*s involvement in other studies which in the opinion of the
- •investigators could affect the safety of the patient or the result of the study;
- •Any other medical condition, which in the opinion of the investigators could
- •affect the safety of the patient*s participation;
- •Medically unable (like positive viral serology) or otherwise unwilling to
- •undergo a leukapheresis procedure.
- •Any psychological, familial, sociological and /or geographical condition
- •potentially hampering compliance with the study protocol and follow-up
研究者
相似试验
招募中
不适用
Immuun interventie met tolerogene dendritische cellen (DC) in type 1 diabetes. Eerste klinische veiligheidsstudie genaamd D-senseDiabetes Mellitus, Type 1ImmunotherapyDendritic cellsSafetyType 1 diabetesImmunotherapieDendritische cellenVeiligheidNL-OMON21892eiden Universitu Medical Center9
尚未招募
不适用
Dendritic cell-based immunotherapy combined with low-dose cyclophosphamide in patients with malignant pleural mesotheliomamesothelioma10035597NL-OMON32554Erasmus MC, Universitair Medisch Centrum Rotterdam10
已完成
不适用
Dendritic cell-based immunotherapy for ovrian cancer patients.NeoplasmsKCT0000831Asan Medical Center10
招募中
不适用
Tolerogenic dendritic cell therapy for rheumatoid arthritis.1000381610023213rheumatoid arthritisNL-OMON55219niversitair Medisch Centrum Utrecht18
已完成
1 期
The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.JPRN-UMIN000014435Medical Corporation Isokai Seren Clinic Tokyo10