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Adipose-derived mesenchymal stem cells (AD-MSCs) in the treatment for psoriasis: results of a single-arm pilot trial

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机构: [1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China [2]Stem Cell Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China [3]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China [4]National Centre for Design Measurement and Evaluation of Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, China [5]Institute of Basic Medical Sciences Chinese Academy of Medical Sciences, School of Basic Medicine Peking Union Medical College.Peking Union Medical College Hospital, Beijing Key Laboratory of New Drug Development and Clinical Trial of Stem Cell Therapy (BZ0381), Beijing, China [6]State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China [7]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China [8]Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guangzhou University of Chinese Medicine, Guangzhou, China
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关键词: Mesenchymal stem cells (MSCs) clinical trials cellular therapy stem cell transplantation psoriasis

摘要:
Background: Psoriasis is an immune-mediated inflammatory skin disease that causes significant physical and psychological burden to the patient. While there is currently no curative treatment, recent breakthroughs involving stem cell therapy, in particular, adipose tissue-derived from mesenchymal stem cells (AD-MSCs), have been promising. This single-arm study evaluated the feasibility, safety, and efficacy of AD-MSC infusions for the treatment of moderate to severe psoriasis. Methods: A single-center, open-label pilot study was conducted involving seven subjects with moderate to severe psoriasis. Patients received intravenous injections of AD-MSCs (0.5x10(6) cells/kg) monthly for 12 weeks. The primary outcome was patient safety evaluated by the incidence of adverse events (AEs). Secondary parameters included changes in the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Body Surface Area (BSA), and Pruritus Scores on the Visual Analogue Scale (VAS). Results: A total of 7 patients, including 6 males and 1 female, with an average age of 50.71 years (range, 35-65 years) were enrolled in this study. Four patients completed the trial and two participants completed the one-year follow-up. There were 16 AEs (including 1 grade 2 event and 15 grade 1 events) recorded during the treatment period and 1 serious adverse event (SAE) documented during the follow-up period. The most common AEs were transient fevers (5/16) which were likely to be related to the infusions, followed by pharyngitis (3/16), and headaches (2/16). Both of them were unlikely to be related to the infusions. The procedure was determined to be safe, and no SAEs relating to AD-MSCs were observed. Two patients reached and maintained a PASI-50, indicating a 50% improvement in the PASI score, after one year without any treatment. Conclusions: These results suggested that intravenous injection of AD-MSCs is safe and may be a therapeutic option for the treatment of patients with psoriasis. Future studies involving larger test cohorts and a control group are warranted.

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出版当年[2020]版
大类 | 3 区 医学
小类 | 3 区 医学:研究与实验 3 区 肿瘤学
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Q2 ONCOLOGY Q2 MEDICINE, RESEARCH & EXPERIMENTAL
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第一作者机构: [1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
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通讯机构: [1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China [5]Institute of Basic Medical Sciences Chinese Academy of Medical Sciences, School of Basic Medicine Peking Union Medical College.Peking Union Medical College Hospital, Beijing Key Laboratory of New Drug Development and Clinical Trial of Stem Cell Therapy (BZ0381), Beijing, China [6]State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China [7]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China [8]Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guangzhou University of Chinese Medicine, Guangzhou, China [*1]Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Yuexiu District, Guangzhou 510120, China. [*2]Institute of Basic Medical Sciences Chinese Academy of Medical Sciences, School of Basic Medicine Peking Union Medical College. Peking Union Medical College Hospital, Beijing Key Laboratory of New Drug Development and Clinical Trial of Stem Cell Therapy (BZ0381), 5 Dongdan Santiao, Dongdan, Dongcheng District, Beijing, China.
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