. 2018 Feb 13;9:252. doi: 10.3389/fimmu.2018.00252

Table 1.

Treg use or planned to be used in clinical trials.

Disease application	Center	Ph	Cell dose	Product	Indication	Effects	Study ID	Ref.
HCT	Gdansk	I	1 × 10⁵–3 × 10⁶/kg	Expanded poly-Tregs	GvHD treatment	Safe/reduced immunosuppression	NKEBN/458-310/2008 (Gdansk ethics board)	(62)
	Minnesota	I	1–30 × 10⁵/kg^a	Expanded CB poly-Tregs	GvHD prophylaxis	Safe reduced acute GvHD, increased infection	NCT00602693 ^b	(44, 63)
	Minnesota	I	3–100 × 10⁶/kg	Expanded CB poly-Tregs with engineered cell line	GvHD prophylaxis	Safe reduced GVHD and no increased relapse	NCT00602693	(45)
	Perugia	I	2–4 × 10⁶/kg	Fresh polyTregs	GvHD prophylaxis	Safe/reduced leukemia relapses/reduced incidence of GvHD	Protocol No 01/08, CEAS Umbria	(64, 65)
	Regensburg	I	≤ 5 × 10⁶/kg	Fresh polyTregs	GvHD prophylaxis	Safe	Treg002EudraCT: 2012-002685-12^c	(56)
	Milan	I	1–3 × 10⁵/kg	Tr1 (IL-10 DLI or DC-10 DLI)	GvHD prophylaxis	Safe/long-term disease-free survival in 4 patients	ALT-TEN, IS/11/6172/8309/8391	(66)
	Stanford	I/II	0.1–10 × 10⁶/kg	Fresh polyTregs	GvHD prophylaxis	Terminated (NCT01050764)Recruiting (NCT01660607)	NCT01050764/NCT01660607	–
	Dresden	I	0.6–5 × 10⁶/kg	Expanded polyTregs	GvHD treatment	Tumors in 2 patients/stable chronic GvHD	Protocol no. EK 206082008	(58)
	Bologna	I/II	0.5–2 × 10⁶/kg	Fresh polyTregs	Chronic GvHD prophylaxis	Recruiting	NCT02749084	–
	Minnesota	I/II		Fresh CB polyTregs with IL-2	GvHD prophylaxis	Recruiting	NCT02991898	–
	Boston	I		Fresh polyTregs with IL-2	Steroid refractory chronic GvHD treatment	Recruiting	NCT01937468	–
	Lisbon	I/II	0.5–3 × 10⁶/kg	Fresh polyTregs	Steroid refractory chronic GvHD treatment	Recruiting	NCT02385019	–
	Stanford	I		polyTregs	Steroid-dependent/refractory chronic GvHD treatment	Unknown	NCT01911039	–
	Liege	I	0.5 × 10⁶/kg	Fresh polyTregs	chronic GvHD treatment	Unknown	NCT01903473	–
	Houston	I/II	1–10 × 10⁶/kg	Fucosylated polyTregs	GvHD prophylaxis	Active, not recruiting	NCT02423915	–
	Tampa	I		Donor expanded Tregs	GvHD prophylaxis	Recruiting	NCT01795573	–
	Minnesota	I	3 × 10–100⁶/kg	Induced Tregs	GvHD prophylaxis	Active, not recruiting	NCT01634217	–

Organ trans	London, Oxford,	I/II	1–10⁶/kg	Expanded polyTregs	Living donor kidney transplant	Recruiting	NCT02129881	(67)
	Berlin	I/II	0.5–3 × 10⁶/kg	Expanded polyTregs	Living donor kidney transplant	Recruiting	NCT02371434	(67)
	San Francisco	I/II	4–10 × 10⁶/kg^d	Donor-alloantigen-reactive Tregs	Living donor kidney transplant	Recruiting	NCT02244801	(67)
	Boston	I/II		Belatacept-conditioned Tregs	Living donor kidney transplant	Active, not recruiting	NCT02091232	(67)
	Chicago	I		Expanded polyTregs	Living donor kidney transplant	Active, not recruiting	NCT02145325	–
	Milan	I/II		Antigen-specific Tr1 (T10 cells)	Living donor kidney transplant	Not yet recruiting		(67)
	Moscow	I	3 × 10⁶/kg^d	Expanded polyTregs	Kidney transplantation	Unknown	NCT01446484	–
	Multicenter USA	I/II	6 × 10⁶/kg	Donor reactive and polyTregs	Kidney transplantation	Recruiting	NCT02711826	–
	London	I	≤ 4.5 × 10⁶/kg	Expanded polyTregs	Liver transplant	Recruiting	ThRIL, NCT02166177	(68)
	Nanjing	I	1 × 10⁶/kg	Alloantigen-specific Tregs	Liver transplant	Unknown	NCT01624077	–
	San Francisco	I	7 × 10⁵–10 × 10⁶/kg^d	Donor-alloantigen-reactive Tregs	Liver transplant	Recruiting	NCT02188719	–

Other Treg-based trials	San Francisco	I	5 × 10⁶/kg^d	Expanded polyTregs	Subclinical rejection in kidney transplantation	Active, not recruiting	NCT02088931	–
Other Treg-based trials	San Francisco	I	4–7 × 10⁶/kg^d	Donor-alloantigen-reactive Tregs	CNI reduction in liver transplantation	Recruiting	NCT02474199	–

Autoimmunity	Gdansk	I	≤ 30 × 10⁶/kg	Expanded polytTregs	Recent T1D	Safe/reduced insulin doses	ISRCTN06128462^e	(69–71)
	San Francisco	I	7 × 10⁴–40 × 10⁶/kg^d	Expanded polyTregs	T1D	Safe	NCT01210664	(72)
	Lille	I/II	1 × 10⁴–10 × 10⁶/kg	Ovalbumin-specific Tr1	Refractory Crohn’s disease	Safe/clinical response in 40% of patients	CATS1	(73)
	Gdansk	I		Expanded polyTregs	Multiple sclerosis	Recruiting		–
	Nanjing	I/II	10–20 × 10⁶/kg	Expanded polyTregs	Autoimmune Hepatitis	Not yet recruiting	NCT02704338	–
	Gdansk	II		Expanded polyTregs	Recent T1D	Recruiting		–
	Hunan	I/II	1–5 × 10⁶/kg	Expanded third-party CB polyTregs	Recent T1D	Recruiting	NCT02932826/NCT03011021	–
	Multicenter USA	II		Expanded polyTregs	Recent T1D	Not yet recruiting	NCT02691247	–
	San Francisco	I	3–20 × 10⁶/kg	Expanded polyTregs	Recent T1D	Recruiting	NCT02772679	–
	San Francisco	I	1.4–23 × 10⁶/kg^d	Expanded polyTregs	Systemic Lupus erythematosus	Not yet recruiting	NCT02428309	–

^aTwo infusions day +4 and day +15 after HCT.

^bclinicaltrials.gov.

^cwww.clinicaltrialsregister.eu.

^dConverted to cells/kg based on 70 kg average body mass if not stated by study (European standard).

^ewww.isrctn.com.