Table 1.
Recent clinical studies on Treg cell therapy in autoimmune disease.
| Autoimmune disease | Treg therapy | Study | Patient No. | Comedications | Treg results | Refs./Study ID |
|---|---|---|---|---|---|---|
| Crohn’s Disease | ova-Tregs isolated from PBMCs Single infusion Tr1 intravenously |
Phase I/IIa | 20 patients | – | Safe, unknown efficiency, well tolerated, | (83) |
| Crohn’s Disease | ova-Tregs, infusion Tr1 intravenously | Phase I/II | 32 participants | Ovasave | Well tolerated | NCT02327221 |
| Crohn’s Disease | Polyclonally expanded CD4+CD25+CD127lowCD45RA+Tregs, Intravenously | Double-blind, placebo-controlled trial | 24 participants | TR004 | Suppression of activation of lamina propria and mesenteric lymph node lymphocytes | NCT03185000 |
| Type 1 Diabetes | Administration of autologous expanded (ex vivo) Tregs | Phase I | 12 DM1 children | Safe and feasible, lower requirement for exogenous insulin. No adverse effects | (79) | |
| Type 1 Diabetes | Administration of autologous expanded Tregs (ex vivo) (CD4+CD127lo/−CD25+ polyclonal Tregs) | Phase I | 14 Patients | Safe and feasible. Retention of CD4+CD25hiCD127loFOXP3+Treg cells | (55) | |
| Type 1 Diabetes | A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile infusion solution. | Phase II | 113 participants | Not Recruiting | NCT02691247 | |
| Type 1 Diabetes | Administration of autologous expanded polyclonal Tregs (ex vivo) single dose of CD4+CD25+CD127low cells and low-dose IL-2 | Phase I | Completed. Low-dose IL-2 expands exogenously administered Tregs | NCT02772679 (84) | ||
| Type 1 Diabetes | Administration of umbilical cord blood Tregs combined to insulin | Open-label phase I/II | 40 participants | More effective than insulin therapy alone. Recruiting | NCT02932826 | |
| Active Cutaneous Lupus | Administration of autologous expanded Tregs (ex vivo) single dose | Phase I | 1 participants | Terminated due to participant recruitment feasibility | NCT02428309 | |
| Active Cutaneous Pemphigus | Infusion of a single dose autologous polyclonally expanded Tregs | Open-label phase I | 5 participants | Active, not recruiting | NCT03239470 | |
| Autoimmune Diabetes | Umbilical cord blood Tregs combined to liraglutide therapy | Phase I/II | 40 participants | Recruiting | NCT03011021 | |
| Autoimmune Hepatitis | Infusion of a single dose autologous polyclonally expanded Tregs | Open-label phase I/II | 30 participants | Not yet recruiting | NCT02704338 | |
| Systemic Lupus Erythematosus | Treg adoptive cell therapy | Clinical study | 1 participant | Increased activated Tregs in inflamed skin with a dynamic shift from Th1 to Th17 responses | (40) | |
| Inflammatory Bowel Disease | Single infusion of regulatory Treg cells (type 1 ovalbumin-specific) | Phase I/IIa clinical study | Well tolerated, dose-related efficacy | (85) | ||
| Pemphigus Vulgaris | Polyclonal autologous Treg cells therapy | Phase Ia multicenter clinical trial | 5 participants | Active, not recruiting | NCT03239470 |
PBMCs, patients’ peripheral blood mononuclear cells; ova-Tregs, Ovalbumin-specific Treg cells.