Immune intervention with tolerogenic dendritic cells in type 1 diabetes. A phase 1 safety study called D-sense
- Conditions
- diabetes10018424type 1 diabetes
- Registration Number
- NL-OMON50354
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
• 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
physician
• 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.
• 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
schedule.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>a. Primary safety endpoints<br /><br>Occurrence of any of the following safety and feasibility concerns:<br /><br>- hypersensitivity reaction grade >= 3 to PIpepTolDC product upon intradermal<br /><br>injections<br /><br>- any infectious complications requiring systemic medical treatment<br /><br>- diagnosis of any new disease associated with autoimmunity<br /><br>- diagnosis of new malignancy<br /><br>- any other serious adverse event<br /><br><br /><br>b. Primary feasibility endpoints<br /><br>- failure to complete a successful leukapheresis procedure<br /><br>- failure to isolate sufficient numbers of mononuclear cells by leukapheresis<br /><br>for PIpepTolDC production<br /><br>- failure to generate the required dose of PIpepTolDCs<br /><br>- any event that prevents the protocol or follow up to be executed as planned.</p><br>
- Secondary Outcome Measures
Name Time Method