Mediators of Inflammation / 2015 / Article / Tab 1

Review Article

Clinical Use of Tolerogenic Dendritic Cells-Harmonization Approach in European Collaborative Effort

Table 1

Completed phase 1 safety studies using tolerance-inducing DC.

GroupIndicationCell culture conditionsAntigen (Ag)Treatment regimenRoute of administrationOutcomesRef.

Giannoukakis, Trucco
Pittsburgh, USA
Type 1 diabetesUse of antisense ODN targeting CD40, CD80, and CD86 in mo-DCNo Ag4 injections of 1 × 107 cells every two weeksIntradermal(i) No AE
(ii) No clinical effect
(iii) Treatment-associated increase of B220+ CD11c+ B cells
(iv) Evidence for reactivation of C-peptide in subjects that were C-peptide negative
[12]

Thomas
Brisbane, Australia
RAAddition of Bay11-7082 to mo-DC culturesCitrullinated peptides: collagen type -Cit1240, fibrinogen chain-Cit720, fibrinogen chain-Cit436, and vimentin-Cit4501 injection of low-dose (0.5–1 × 106 cells) or high-dose (2–4.5 × 106 cells)Intradermal(i) Grade 1 AE (injection site reactions, transient leucopenia, and headache)
(ii) No induction of disease flares and reduction of DAS28 in treated patients
(iii) Systemic anti-inflammatory effect based on CRP levels, reduced frequency of Teff, and proinflammatory cytokines and chemokines in treated patients
[10]

Panes, Benitez-Ribas, and Ricart
Barcelona, Spain
Crohn’s diseaseAddition of dexamethasone and vitamin A to mo-DC culturesNo AgDose-escalation study: a single or 3 consecutive injections at 2-week intervals of 2 × 106, 5 × 106, and 10 × 106 cellsIntraperitoneal(i) No AE (3 patients withdrew because of worsening of disease symptoms)
(ii) Clinical improvement in 3 out of 13 patients (1 clinical remission, 2 clinical responses)
(iii) Increase of circulating Treg and decrease in IFN- levels
[11]

Hilkens, Isaacs
Newcastle upon Tyne, UK
Inflammatory arthritisAddition of dexamethasone and vitamin D to mo-DC culturesAutologous synovial fluidDose-escalation study: a single injection of 1 × 106, 3 × 106, and 10 × 106 cellsIntra-articular(i) No evidence of acute toxicity
(ii) Treatment acceptable to patients

Joo, Bae
Seoul, South Korea
RACreaVax-RA (autologous tolerogenic DC)recombinant PAD4, RA33, citrullinated-filaggrin and vimentin 5 injections of low-dose (0.5 × 107 cells) and high-dose (1.5 × 107)Not indicated(i) Treatment was well tolerated
(ii) Antigen-specific autoantibodies decreased in 5/9 autoantibody-pos. patients
[34]

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