Allogenic mesenchymal stem cells transplantation in refractory systemic lupus erythematosus: a pilot clinical study.
OBJECTIVE
To determine the safety and efficacy of allogeneic mesenchymal stem cell transplantation (MSCT) in refractory systemic lupus erythematosus (SLE).


METHODS
A total of 15 patients with persistently active SLE underwent MSCT. Outcome was evaluated by changes in the SLE disease activity index (SLEDAI), serological features (anti-nuclear antibodies and anti-double-stranded DNA (anti-dsDNA)), renal function and percentage of peripheral blood regulatory T cells.


RESULTS
From 11 March 2007 to 4 November 2008, 15 patients with persistently active SLE were enrolled and underwent MSCT. The mean follow-up period was 17.2+/-9.5 months. A total of 13 patients have been followed for more than 12 months. All patients clinically improved following treatment with mesenchymal stem cells with a marked decrease in the SLEDAI score and 24 h proteinuria. At 12-month follow-up, SLEDAI scores decreased from 12.2+/-3.3 to 3.2+/-2.8 and proteinuria decreased from 2505.0+/-1323.9 to 858.0+/-800.7 mg/24 h (all p<0.05, by paired t test, n=12). At 1-year follow-up in 13 patients, 2 had a relapse of proteinuria, while the other 11 continue to have decreased disease activity on minimal treatment. Anti-dsDNA levels decreased. Improvement in glomerular filtration rate was noted in two patients in which formal testing was performed. Non-renal-related manifestations also improved significantly. No serious adverse events were reported.


CONCLUSIONS
Allogeneic MSCT in patients with refractory lupus resulted in amelioration of disease activity, improvement in serological markers and stabilisation of renal function. MSCT appears beneficial in treatment of patients with SLE refractory to conventional treatment options.
Liang
Jun
J
Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.
Zhang
Huayong
H
Hua
Bingzhu
B
Wang
Hong
H
Lu
Liwei
L
Shi
Songtao
S
Hou
Yayi
Y
Zeng
Xiaofeng
X
Gilkeson
Gary S
GS
Sun
Lingyun
L
D000293:Adolescent; D000328:Adult; D000974:Antibodies, Antinuclear / Q000097:blood; D002648:Child; D004247:DNA / Q000276:immunology; D004812:Epidemiologic Methods; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000276:immunology / Q000628:therapy*; D008181:Lupus Nephritis / Q000503:physiopathology / Q000628:therapy; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D050378:T-Lymphocytes, Regulatory / Q000276:immunology; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
D000974:Antibodies, Antinuclear; D004247:DNA