Table 1.

Clinical trials of Tregs against autoimmune diseases

Disease	Expansion: autologous or polyclonal Treg cells	Description of application and dose	Outcome of clinical trial and final status	References
Crohn`s disease	PBMC derived ovalbumin specific Treg cells expanded under in vitro condition designated as ovasve NCT02327221	Single infusionof cells ranging from 106 to 109in number per patients	Well tolerated yet adverse effect has been observed in 54 patients, all recovered without showing any further adverse effect	64
Croh`n disease	Polyclonally expanded autologous CD4+ CD25+ CD127lowCD45RA+Tregs treated with rapamycin and retinoic acid receptor agonistNCT03185000	0.5–1 x 10 6 cells up to 8–0 × 10 6 cells /kg body weight	Expressed α4β7 and exhibit suppressive function with migratory activities in cell culture system. Final results not posted till Nov. 2021	65
Type1 diabetes T1D	Autologous ex vivo Tregs CD4+ CD25+ CD127, lowISRCTN06128462	10 x 106–30 × 06per kg body weight	Absence of serious adverse effect without insulin dependency. Clinical trials completed	58
T1D	Autologous enriched Tregs derived from PBMC, ex vivo expandedNCT01210664	0.5 x 10 8 to 26 × 10 8 Tregs infused as single dose via i/v route per patient	About 25% of peak level of circulatory Tregs persisted for one year after transfer. Transient increase in FOXP3(+)CD4(+)CD25(hi)CD127(lo) phenotype Tregs in recipients was observed. Adverse effect was observed in 3 out of 14 patients, not related to cell infusion. Ddeuterium labeling was absent in non-Treg cells indicating Tregs stability. C-peptide indicator of insulin production persisted up to 2 years of Treg cell transfer. Clinical trials completed	66
T1D	CD4 + CD25 + CD127 lowTregs derived from autologous PBMCenriched under in-vitro condition, under Phase-I. Clinical trial NCT02772679	3 x 10 6–20 × 10 6 cells per kg, s/c route	No result posted as on November 2021	35
T1D	Umbilical cord blood derived TregsPhase-I and Phase-II trialNCT02932826	Tregs with insulin and insulin alone	40 participants were incorporated in the trial and result not published till Nov 2021	35
Active cutaneous lupus	Autologous ex vivo expanded and enriched Tregs, under Phase-I. Clinical trials NCT02428309	1 x 10 8 deuterium labeled Tregs cells per patients	Increase population of Tregs and IL-17 production by both CD4 and CD8 cells recorded in skin biopsies. Terminated due to participantrecruitment feasibility	67
Pemphigus Vulgaris	Ex vivo expanded autologous CD4+ CD127lo/negCD25polyclonal TregsNCT03239470	1.0 x 10 8 and2.5 x 10 8 cells per patients of 18 to 75 years age	Recovery criteria was to detect CD4+, CD25++, CD127 low Treg in patients using cell shorting system. Results submitted during October 2021 but detail is under quality control process for further recruiting,	68
Auto immune hepatitis	Polyclonally expanded autologous Tregs for phase I/II clinical trials NCT02704338	10–20 × 10 6 cells in a single infusion to patients aged between 10–70 years	Initiated at Nanjing Medical University China. Further information not yet published	35