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Allogenic mesenchymal stem cells transplantation in refractory systemic lupus erythematosus: a pilot clinical study
  1. Jun Liang1,
  2. Huayong Zhang1,
  3. Bingzhu Hua1,
  4. Hong Wang1,
  5. Liwei Lu2,
  6. Songtao Shi3,
  7. Yayi Hou4,
  8. Xiaofeng Zeng5,
  9. Gary S Gilkeson1,6,
  10. Lingyun Sun1
  1. 1Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China
  2. 2Department of Pathology, The University of Hong Kong, Hong Kong, China
  3. 3Center for Craniofacial Molecular Biology, University of Southern California School of Dentistry, Los Angeles, California, USA
  4. 4Immunology Laboratory, Nanjing University Medical School, Nanjing, China
  5. 5Department of Rheumatology, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
  6. 6Division of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA
  1. Correspondence toDr Lingyun Sun, Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, Jiangsu 210008, China; lingyunsun2001{at}
  2. Dr Gary S Gilkeson, Department of Rheumatology, 96 Jonathan Lucas Street, Suite 912 Medical University of South Carolina, Charleston, South Carolina 29425, USA; gilkeson{at}


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.

Conclusion 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.

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  • JL and HZ authors contributed equally to this work.

  • Funding This study was supported by grants from the National Natural Science Foundation of China (no. 30772014), National 115 Supporting Program (2008BAI59B02), Jiangsu Province 135 Talent Foundation (RC2007002), Jiangsu Province Natural Science Foundation and Jiangsu Province Six Summit Talent Foundation.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the Ethics Committee at Drum Tower Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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