Table 3.

Chronic GVHD characteristics and response following autologous MSC infusion.

Study ID	Dose level	# Doses	Time from GVHD dx (years)	Baseline severity	Treatment on day 1	Other treatments	Severity at last f/u	Overall response1	Steroid dose (mg/kg)
EPIC2014-07	2	2	2.1	Severe	Steroid, FK2	Sirolimus, MMF, ruxolitinib, ECP, imatinib, MTX, rituximab	Severe	PR	0.3→0.3
EPIC2014-12	2	2	0.23	Mod	Steroid	FK, ruxolitinib	Mod	PR	0.5→0.2
EPIC2014-13	2	2	0.54	Severe	FK5	Steroid, ruxolitinib, ibrutinib, ECP	Severe	PD	0→0
EPIC2014-14	3	4	1.7	Severe	Steroid, FK, ruxolitinib	N/A	Severe	SD	0.1→0.1
EPIC2014-16	3	4	6.2	Severe	Steroid, sirolimus, ibrutinib6	FK, ECP	Severe	PR	0.6→0.4
EPIC2014-177	3	2	4.4	Severe	Ruxolitinib, MMF	Steroid, rituximab, FK, MMF, imatinib, sirolimus, ECP, ruxolitinib	Mod	PR	0→0
EPIC2014-188	3	4	0.2	Mild	Steroid, FK, ruxolitinib	N/A	Mild	PR	0.2→0

GVHD, graft-versus-host disease; MSC, mesenchymal stromal cells; dx, diagnosis; f/u, follow-up; mod, moderate; FK, tacrolimus; MMF, mycophenolate mofetil; ECP, extracorporeal photopheresis; MTX, methotrexate; PR, partial response; PD, progressive disease; SD, stable disease; EGD, esophagogastroduodenoscopy; UGI, upper gastrointestinal; LGI, lower GI.

(1)Overall response assessed at 3 months following first MSC infusion.

(2)Ibrutinib started 3 months following first MSC infusion.

(3)Date of diagnostic EGD, prior history of skin and nail chronic GVHD.

(4)Overlap GVHD diagnosed on 4/30/2015.

(5)Jakafi started at 9 months following first MSC infusion.

(6)Ruxolitinib started 5 months following first MSC infusion and ibrutinib discontinued.

(7)History of acute skin only GVHD, quiescent at study enrollment.

(8)At enrollment, patient had acute GVHD (stage 1 UGI, 2 LGI); at treatment, patient had only chronic GVHD.