Immuun interventie met tolerogene dendritische cellen (DC) in type 1 diabetes. Eerste klinische veiligheidsstudie genaamd D-sense
Recruiting
- Conditions
- Diabetes Mellitus, Type 1ImmunotherapyDendritic cellsSafetyType 1 diabetesImmunotherapieDendritische cellenVeiligheid
- Registration Number
- NL-OMON21892
- Lead Sponsor
- eiden Universitu Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
• Age 18-50 years;
• Diagnosis of type 1 Diabetes Mellitus at least 18 months (dated from the first insulin injection);
Exclusion Criteria
• 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a. Primary safety endpoints<br /><br>Occurrence of any of the following safety and feasibility concerns:<br /><br>- hypersensitivity reaction grade ¡Ý 3 to PIpepTolDC product upon intradermal injections<br /><br>- disease exacerbation as defined by ¡Ý 40% decrease of stimulated C-peptide production compared to baseline<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>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 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.
- Secondary Outcome Measures
Name Time Method Secondary endpoints<br /><br>- Improved stimulated C-peptide production compared to baseline at 12 and 24 weeks<br /><br>- Change in the level or quality of T-cell specific immune responses at 4, 8, 12, and 24 weeks versus baseline