4.7 Article

Human umbilical cord mesenchymal stem cells for psoriasis: a phase 1/2a, single-arm study

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SPRINGERNATURE
DOI: 10.1038/s41392-022-01059-y

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Funding

  1. National Key Research and Development Project of China [2020YFA0112900, 2018YFC0117004]
  2. National Natural Science Foundation of China [82073447, 81573049]
  3. Key Research and Development Program of Hunan Province [2018SK2082]
  4. Research and Development Project of Hunan Guangxiu High-tech Life Technology Co., Ltd [2019RES08]

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This study showed that allogeneic umbilical cord-derived mesenchymal stem cell (UMSC) transplantation is safe and partially effective in treating patients with psoriasis, with regulatory T cell (Treg) levels potentially serving as a potent biomarker for predicting the clinical efficacy of UMSC therapy.
Psoriasis is a common, chronic immune-mediated systemic 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

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