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A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis
  1. DanQi Deng1,
  2. Peilian Zhang1,
  3. Yun Guo1,
  4. Teck Onn Lim2
  1. 1 Department of Dermatology, 2nd Affiliated Hospital of Kunming Medical University, SLE Research Centre, Kunming, Yunnan, China
  2. 2 ClinResearch Sdn Bhd, Petaling Jaya, Malaysia
  1. Correspondence to Dr Teck Onn Lim, D7-3-1 (First Floor) Block D7, Pusat Perdagangan Dana 1, Jalan PJU 1A/46, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia; limteckonn{at}gmail.com

Abstract

Objective We evaluate the efficacy of human umbilical cord-derived mesenchymal stem cell (hUC-MSC) for the treatment of lupus nephritis (LN). Previous reports showed hUC-MSC could have dramatic treatment effect.

Methods Eighteen patients with WHO class III or IV LN were randomly assigned to hUC-MSC (dose 2×108 cells) or placebo. All patients received standard immunosuppressive treatment, which consisted of intravenous methylprednisolone and cyclophosphamide, followed by maintenance oral prednisolone and mycophenolate mofetil.

Results Remission occurred in 9 of 12 patients (75%) in the hUC-MSC group and 5 of 6 patients (83%) in the placebo group. Remission was defined as stabilisation or improvement in renal function, reduction in urinary red cells and protein. A similar proportion of patients on hUC-MSC and placebo achieved complete remission. Improvements in serum albumin, complement, renal function, Systemic Lupus Erythematosus Disease Activity Index and British Isles Lupus Assessment Group scores were similar in both groups. One patient on placebo had a stroke and another had ascites. One patient on hUC-MSC had leucopenia, pneumonia and subcutaneous abscess and another died of severe pneumonia. The trial was abandoned after 18 patients were enrolled when it had become obvious it would not demonstrate a positive treatment effect.

Conclusion hUC-MSC has no apparent additional effect over and above standard immunosuppression.

Trial registration number NCT01539902; Results.

  • Systemic lupus erythematosus
  • Lupus Nephritis
  • Mesenchymal Stem Cell
  • randomized controlled trial

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Footnotes

  • Contributors DD, PZ, YG and TOL participated in the original conception of the research idea, design of the study, development of the study protocol, study conduct at the trial site, analysis of the data, writing and revision of the paper.

  • Funding This research was funded by Beike Biotech and CytoMed Sdn Bhd.

  • Competing interests None declared.

  • Ethics approval This study was approved by the institutional review-board of the 2nd Affiliated HospitalKunming Medical University.

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

  • Data sharing statement There is no additional unpublished data from the study. The authors will make available all data from this research for purpose independentverification of the results or for use in meta-analysis.

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