Human umbilical cord mesenchymal stem cells for psoriasis: a phase 1/2a, single-arm study
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Release time:2022-12-20
Journal:Signal Transduction and Targeted Therapy
Funded by:国家重点研发计划
Abstract:Psoriasis is a common, chronic immune-mediated skin disease that had no effective and durable treatment. Mesenchymal stem
cells (MSCs) have immunomodulatory properties. Therefore, we performed a phase 1/2a, single-arm clinical trial to evaluate the
safety and efficacy of human umbilical cord-derived MSCs (UMSCs) in the treatment of psoriasis and to preliminarily explore the
possible mechanisms. Seventeen patients with psoriasis were enrolled and received UMSC infusions. Adverse events, laboratory
parameters, PASI, and PGA were analyzed. We did not observe obvious side effects during the treatment and 6-month follow-up. A
total of 47.1% (8/17) of the psoriasis patients had at least 40% improvement in the PASI score, and 17.6% (3/17) had no sign of
disease or minimal disease based on the PGA score. And the efficiency was 25% (2/8) for males and 66.7% (6/9) for females. After
UMSC transplantation (UMSCT), the frequencies of Tregs and CD4+ memory T cells were significantly increased, and the frequencies
of T helper (Th) 17 and CD4+ naive T cells were significantly decreased in peripheral blood (PB) of psoriasis patients. And all
responders showed significant increases in Tregs and CD4+ memory T cells, and significant decreases in Th17 cells and serum IL-17
level after UMSCT. And baseline level of Tregs in responders were significantly lower than those in nonresponders. In conclusion,
allogeneic UMSCT is safe and partially effective in psoriasis patients, and level of Tregs may be used as a potent biomarker to
predict the clinical efficacy of UMSCT. Trial registration Clinical Trials NCT03765957
Indexed by:Article
Translation or Not:no
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