Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report

BackgroundSjögren’s syndrome (SS) is a systemic autoimmune disease, with major symptoms including dry mouth and dry eyes, for which there is no effective treatment. Recent studies have demonstrated that mesenchymal stem cells (MSCs) are effective in the treatment of SS, but the efficacy of allogenei...

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Main Authors: Zhao-Xia Ma, Xing-Fei Wu, Li Cao, Cheng-Yan Jiao, Dai-Ping Ma, Yun-Hui Zhao, Zhi-Xing Yang, Min Hu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Immunology
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Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2025.1529883/full
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author Zhao-Xia Ma
Xing-Fei Wu
Li Cao
Cheng-Yan Jiao
Dai-Ping Ma
Yun-Hui Zhao
Zhi-Xing Yang
Min Hu
Min Hu
author_facet Zhao-Xia Ma
Xing-Fei Wu
Li Cao
Cheng-Yan Jiao
Dai-Ping Ma
Yun-Hui Zhao
Zhi-Xing Yang
Min Hu
Min Hu
author_sort Zhao-Xia Ma
collection DOAJ
description BackgroundSjögren’s syndrome (SS) is a systemic autoimmune disease, with major symptoms including dry mouth and dry eyes, for which there is no effective treatment. Recent studies have demonstrated that mesenchymal stem cells (MSCs) are effective in the treatment of SS, but the efficacy of allogeneic MSCs is affected by variability among different cell donors, and they are easily cleared by the immune system of the recipient. Autologous MSCs are one of the ideal options for the treatment of SS; however, their function decreases with age. Regenerative fibroblast (rFib) is a type of new MSC obtained through chemical reprogramming technology from skin fibroblasts. In this study, we report the safety and efficacy of intravenous infusion of autologous rFib in a volunteer with SS.Case reportIn March 2021, the volunteer was diagnosed with SS due to positive anti-SSB antibodies, lymphocyte infiltration in the lip gland, dry eyes, and a large area of purpura in both lower limbs. From May 2021 to November 2022, she received allogeneic Umbilical cord mesenchymal stem cells (UCMSC) therapy (5.0 × 107 UCMSCs per time, totaling 10 infusions), but her condition did not improve. In May 2023, the rFib for the volunteer was prepared, meeting the quality standard of T/CSCB0003-2021 Human Mesenchymal Stem Cells. Between October 2023 and June 2024, the volunteer received a total of 12 intravenous transfusions of autologous rFib. After the treatments, the volunteer experienced no recurrence of purpura in both lower limbs. Symptoms of dry mouth, dry eyes, and fatigue were relieved. ESR, B lymphocytes, rheumatoid factor IgM, and IgA declined, while the proportion of NK cells increased, and most of the cytokines returned to normal levels. In vitro experiments showed that rFib could significantly inhibit the proliferation of T lymphocytes after PHA stimulation. No adverse effects were associated with the use of rFib in the volunteer during the clinical trial.SummaryThe results of this clinical trial indicate that intravenous injections of autologous rFib are both safe and effective for treating SS. Autologous rFib may be more suitable for treating autoimmune diseases than allogeneic MSCs.
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spelling doaj-art-66e6cc858f454c5eb4e550ea6de2fbb92025-01-27T13:56:44ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-01-011610.3389/fimmu.2025.15298831529883Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case reportZhao-Xia Ma0Xing-Fei Wu1Li Cao2Cheng-Yan Jiao3Dai-Ping Ma4Yun-Hui Zhao5Zhi-Xing Yang6Min Hu7Min Hu8Yunnan Key Laboratory for Basic Research on Bone and Joint Diseases, Kunming University, Kunming, Yunnan, ChinaProduction Department, Yunnan Jici Institute for Regenerative Medicine Co., Ltd, Kunming, Yunnan, ChinaProduction Department, Yunnan Jici Institute for Regenerative Medicine Co., Ltd, Kunming, Yunnan, ChinaProduction Department, Yunnan Jici Institute for Regenerative Medicine Co., Ltd, Kunming, Yunnan, ChinaProduction Department, Yunnan Jici Institute for Regenerative Medicine Co., Ltd, Kunming, Yunnan, ChinaProduction Department, Yunnan Jici Institute for Regenerative Medicine Co., Ltd, Kunming, Yunnan, ChinaProduction Department, Yunnan Jici Institute for Regenerative Medicine Co., Ltd, Kunming, Yunnan, ChinaYunnan Key Laboratory for Basic Research on Bone and Joint Diseases, Kunming University, Kunming, Yunnan, ChinaResearch and Development Department, Shenzhen Zhendejici Pharmaceutical Research and Development Co., Ltd., Shenzhen, Guangdong, ChinaBackgroundSjögren’s syndrome (SS) is a systemic autoimmune disease, with major symptoms including dry mouth and dry eyes, for which there is no effective treatment. Recent studies have demonstrated that mesenchymal stem cells (MSCs) are effective in the treatment of SS, but the efficacy of allogeneic MSCs is affected by variability among different cell donors, and they are easily cleared by the immune system of the recipient. Autologous MSCs are one of the ideal options for the treatment of SS; however, their function decreases with age. Regenerative fibroblast (rFib) is a type of new MSC obtained through chemical reprogramming technology from skin fibroblasts. In this study, we report the safety and efficacy of intravenous infusion of autologous rFib in a volunteer with SS.Case reportIn March 2021, the volunteer was diagnosed with SS due to positive anti-SSB antibodies, lymphocyte infiltration in the lip gland, dry eyes, and a large area of purpura in both lower limbs. From May 2021 to November 2022, she received allogeneic Umbilical cord mesenchymal stem cells (UCMSC) therapy (5.0 × 107 UCMSCs per time, totaling 10 infusions), but her condition did not improve. In May 2023, the rFib for the volunteer was prepared, meeting the quality standard of T/CSCB0003-2021 Human Mesenchymal Stem Cells. Between October 2023 and June 2024, the volunteer received a total of 12 intravenous transfusions of autologous rFib. After the treatments, the volunteer experienced no recurrence of purpura in both lower limbs. Symptoms of dry mouth, dry eyes, and fatigue were relieved. ESR, B lymphocytes, rheumatoid factor IgM, and IgA declined, while the proportion of NK cells increased, and most of the cytokines returned to normal levels. In vitro experiments showed that rFib could significantly inhibit the proliferation of T lymphocytes after PHA stimulation. No adverse effects were associated with the use of rFib in the volunteer during the clinical trial.SummaryThe results of this clinical trial indicate that intravenous injections of autologous rFib are both safe and effective for treating SS. Autologous rFib may be more suitable for treating autoimmune diseases than allogeneic MSCs.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1529883/fullcase reportSjögren’s syndromeregenerative fibroblastspurpuracytokines
spellingShingle Zhao-Xia Ma
Xing-Fei Wu
Li Cao
Cheng-Yan Jiao
Dai-Ping Ma
Yun-Hui Zhao
Zhi-Xing Yang
Min Hu
Min Hu
Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report
Frontiers in Immunology
case report
Sjögren’s syndrome
regenerative fibroblasts
purpura
cytokines
title Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report
title_full Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report
title_fullStr Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report
title_full_unstemmed Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report
title_short Regenerative fibroblasts derived from autologous skin tissue for the treatment of Sjögren’s syndrome: a case report
title_sort regenerative fibroblasts derived from autologous skin tissue for the treatment of sjogren s syndrome a case report
topic case report
Sjögren’s syndrome
regenerative fibroblasts
purpura
cytokines
url https://www.frontiersin.org/articles/10.3389/fimmu.2025.1529883/full
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