A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis.
Ann Rheum Dis
; 76(8): 1436-1439, 2017 Aug.
Article
en En
| MEDLINE
| ID: mdl-28478399
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Asunto principal:
Nefritis Lúpica
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Trasplante de Células Madre Mesenquimatosas
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Glucocorticoides
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Inmunosupresores
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Female
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Humans
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Male
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2017
Tipo del documento:
Article
País de afiliación:
China