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Immuun interventie met tolerogene dendritische cellen (DC) in type 1 diabetes. Eerste klinische veiligheidsstudie genaamd D-sense


- candidate number22937
- NTR NumberNTR5542
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-okt-2015
- Secondary IDsABR48984 
- Public TitleImmuun interventie met tolerogene dendritische cellen (DC) in type 1 diabetes. Eerste klinische veiligheidsstudie genaamd D-sense
- Scientific TitleImmune intervention with tolerogenic dendritic cells in type 1 diabetes. A phase 1 safety study called D-sense
- ACRONYMD-sense
- hypothesisDiabetes Mellitus type 1 is an autoimmune disease that cannot be cured. Complications due to insufficient regulation of blood glucose by exogenous insulin reduce life expectancy and quality of life. Proinsuline-loaded Tolerogenic DCs are induce antigen-specific Tregs and thereby inhibit autoimmune destruction of beta-cells.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I), Immune therapy
- Inclusion criteria• Age 18-50 years;
• Diagnosis of type 1 Diabetes Mellitus 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 and witnessed informed consent.
- 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;
• 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 type 1 Diabetes Mellitus;
• 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) fasting insulin C-peptide > 200 pmol/L;
• Peak insulin C-peptide < 200 pmol/L after stimulation with Mixed Meal Tolerance Tests (MMTT).
• Recent (< 3 months) HbA1c > 64 mmol/ mol.
• No positive beta-cell autoantibody or antibodies (eligible autoantibodies: anti IAA, GADA or dIA-2A)
• Female patients who are pregnant or breastfeeding;
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate1-mei-2017
- Target number of participants9
- InterventionsTwo intradermal injections of PIpepTolDCs (5x 10e6, 10x 10e6 or 20 x 10e6/ injection in 3 patients each) with a 28-day interval.
- Primary outcomea. Primary safety endpoints
Occurrence of any of the following safety and feasibility concerns:
- hypersensitivity reaction grade ¡Ư 3 to PIpepTolDC product upon intradermal injections
- disease exacerbation as defined by ¡Ư 40% decrease of stimulated C-peptide production compared to baseline
- any infectious complications requiring systemic medical treatment
- diagnosis of any new disease associated with autoimmunity
- diagnosis of new malignancy
- any other serious adverse event
b. Primary feasibility endpoints
- failure to complete a successful leukapheresis procedure
- failure to isolate sufficient numbers of mononuclear cells by leukapheresis for PIpepTolDC production
- failure to generate the required dose of PIpepTolDCs
- any event that prevents the protocol or follow up to be executed as planned.
- Secondary outcomeSecondary endpoints
- Improved stimulated C-peptide production compared to baseline at 12 and 24 weeks
- Change in the level or quality of T-cell specific immune responses at 4, 8, 12, and 24 weeks versus baseline
- Timepointsweeks: 4, 8, 12, 24
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.J. Zwaginga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Bart Roep
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
FP7 EU, NAIMIT
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD2-okt-2015 - 4-feb-2016


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