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

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-...

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Published inAnnals of translational medicine Vol. 9; no. 22; p. 1653
Main Authors Yao, Danni, Ye, Shuyan, He, Ziyang, Huang, Yu, Deng, Jingwen, Wen, Zehuai, Chen, Xinsheng, Li, Hongyi, Han, Qin, Deng, Hao, Zhao, Robert Chunhua, Lu, Chuanjian
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Published China AME Publishing Company 01.11.2021
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Abstract 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. A single-center, open-label pilot study was conducted involving seven subjects with moderate to severe psoriasis. Patients received intravenous injections of AD-MSCs (0.5×10 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). 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. 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.
AbstractList 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. A single-center, open-label pilot study was conducted involving seven subjects with moderate to severe psoriasis. Patients received intravenous injections of AD-MSCs (0.5×10 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). 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. 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.
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.BACKGROUNDPsoriasis 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.A single-center, open-label pilot study was conducted involving seven subjects with moderate to severe psoriasis. Patients received intravenous injections of AD-MSCs (0.5×106 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).METHODSA single-center, open-label pilot study was conducted involving seven subjects with moderate to severe psoriasis. Patients received intravenous injections of AD-MSCs (0.5×106 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).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.RESULTSA 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.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.CONCLUSIONSThese 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.
Author Ye, Shuyan
Chen, Xinsheng
Zhao, Robert Chunhua
Yao, Danni
He, Ziyang
Huang, Yu
Li, Hongyi
Deng, Hao
Lu, Chuanjian
Deng, Jingwen
Han, Qin
Wen, Zehuai
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Copyright 2021 Annals of Translational Medicine. All rights reserved.
2021 Annals of Translational Medicine. All rights reserved. 2021 Annals of Translational Medicine.
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Keywords Mesenchymal stem cells (MSCs)
clinical trials
cellular therapy
psoriasis
stem cell transplantation
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Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0.
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These authors contributed equally to this work.
Contributions: (I) Conception and design: C Lu, D Yao, Z Wen, Z He, RC Zhao; (II) Administrative support: D Yao, S Ye, J Deng, C Lu; (III) Provision of study materials or patients: D Yao, S Ye, Z He, Y Huang, Q Han; (IV) Collection and assembly of data: D Yao, S Ye, Z He, X Chen, H Li, Y Huang, H Deng; (V) Data analysis and interpretation: D Yao, S Ye, Y Huang, J Deng; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
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Title Adipose-derived mesenchymal stem cells (AD-MSCs) in the treatment for psoriasis: results of a single-arm pilot trial
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