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Umbilical cord stem cell transplantation produced positive safety profile in SLE patients
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Umbilical cord-derived mesenchymal stem cell transplantation generated positive results in patients with systemic lupus erythematosus, according to data from a recent study.
Researchers conducted a cohort study with 40 patients with active systemic lupus erythematosus (SLE) from December 2009 to August 2011 in China. All patients had treatment-refractory and active disease with a SLE Disease Activity Index (SLEDAI) score of more than eight or at least one British Isles Lupus Assessment Group (BILAG) grade A or at least two BILAG grade B manifestations.
Fresh umbilical cords, obtained from healthy mothers after normal deliveries, were used for transplantation. Allogenic umbilical cord mesenchymal stem cell transplantation (UCMSC) was infused intravenously on days 0 and 7. Primary endpoints included safety profiles, and second endpoints assessed major clinical response (MCR), partial clinical response (PCR) and relapse. Follow-ups occurred at 1, 3, 6, 9 and 12 months after transplantation (MSCT).
The overall survival rate was 92.5%, with 13 patients achieving MCR, and 11 reaching PCR at 12 months. After clinical response, three patients relapsed at 9 months and four at 12 months follow-up.
SLEDAI score significantly decreased from baseline at 3, 6, 9 and 12 months (P<.01 at all periods). Total BILAG score decreased at 3 months and continued to decrease at subsequent follow-ups (P<.001 for all). BILAG scores for renal, hematopoietic and cutaneous systems significantly improved.
For patients with lupus nephritis, 24-hour proteinuria declined after transplantation at 9 and 12 months (P<.05). Serum creatinine and urea nitrogen decreased to the lowest levels at 6 months, before increasing slightly at 9 and 12 months because of relapse. Serum levels of albumin and complement three increased after MSCT, peaked at 6 months and then slightly waned at 9 and 12 months follow-up. Serum antinuclear antibody and anti-double-strand DNA antibody decreased after MSCT.
“Our multicenter clinical study illustrated the safety and efficacy of systemic administration of UC MSCs in SLE patients,” researchers said. “Moreover, a repeated MSC infusion is feasible and necessary after 6 months to avoid disease relapse.”
Disclosure: The researchers report no relevant financial disclosures.
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