Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Case Reports
. 2025 Jan 27:16:1529883.
doi: 10.3389/fimmu.2025.1529883. eCollection 2025.

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

Zhao-Xia Ma  1 , Xing-Fei Wu  2 , Li Cao  2 , Cheng-Yan Jiao  2 , Dai-Ping Ma  2 , Yun-Hui Zhao  2 , Zhi-Xing Yang  2 , Min Hu  1   3
Affiliations
Case Reports

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

Zhao-Xia Ma et al. Front Immunol. .

Abstract

Background: Sjögren'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 report: In 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.

Summary: The 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.

Keywords: Sjögren’s syndrome; case report; cytokines; purpura; regenerative fibroblasts.

PubMed Disclaimer

Conflict of interest statement

Authors X-FW, LC, C-YJ, D-PM, Y-HZ, Z-XY were employed by the company Yunnan Jici Institute for Regenerative Medicine Co., Ltd. MH was employed by the company Shenzhen Zhendejici Pharmaceutical Research and Development Co., Ltd. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Shenzhen Zhendejici Pharmaceutical Research and Development Co. Ltd. The funder had the following involvement in the study: Provide rFib cell samples.

Figures

Figure 1
Figure 1
Preparation and functional identification of autologous rFib cells. (A) Preparation diagram of rFib. (B, C) rFib differentiation into osteoblasts, adipocytes, and chondrocytes. (D) Secretion of VEGF and PDGFA by rFib in vitro. (E) Immune regulatory functions of rFib. Data are presented as the mean ± SD (n = 5or6) with *P < 0.05, **P < 0.01, ***P < 0.001.
Figure 2
Figure 2
Volunteer’s diagnosed SS and its treatment process.
Figure 3
Figure 3
Changes in purpura in both lower limbs. (A) Before allogeneic UCMSC infusion. (B) After three intravenous allogeneic UCMSC infusions. (C) After six intravenous allogeneic UCMSC infusions. (D) After nine intravenous allogeneic UCMSC infusions. (E) Before 10 intravenous allogeneic UCMSC infusions. (F) After 10 intravenous allogeneic UCMSC infusions. (G) Before infusion of autologous rFib. (H) After four intravenous autologous rFib infusion. (I) After 12 intravenous autologous rFib infusion. (J) One year after the infusion of autologous rFib.
See this image and copyright information in PMC

References

    1. Zhan Q, Zhang J, Lin Y, Chen W, Fan X, Zhang D. Pathogenesis and treatment of Sjogren’s syndrome: Review and update. Front Immunol. (2023) 14:1127417. doi: 10.3389/fimmu.2023.1127417 - DOI - PMC - PubMed
    1. Cornec D, Devauchelle-Pensec V, Mariette X, Jousse-Joulin S, Berthelot JM, Perdriger A, et al. . Severe health-related quality of life impairment in active primary sjogren’s syndrome and volunteer-reported outcomes: Data from a Large therapeutic trial. Arthritis Care Res (Hoboken). (2017) 69:528–35. doi: 10.1002/acr.22974 - DOI - PubMed
    1. Zhou Z, Jiang W, Wang M, Liu Y, Zhang W, Huang M, et al. . Primary Sjögren syndrome that initially presented with repeated hypergammaglobulinemic purpura after prolonged sitting: A case report. Med (Baltimore). (2017) 96:e9187. doi: 10.1097/MD.0000000000009187 - DOI - PMC - PubMed
    1. Bossini N, Savoldi S, Franceschini F, Mombelloni S, Baronio M, Cavazzana I, et al. . Clinical and morphological features of kidney involvement in primary sjogren’s syndrome. Nephrol Dial Transplant. (2001) 16:2328–36. doi: 10.1093/ndt/16.12.2328 - DOI - PubMed
    1. Sambataro G, Ferro F, Orlandi M, Sambataro D, Torrisi SE, Quartuccio L, et al. . Clinical, morphological features and prognostic factors associated with interstitial lung disease in primary sjgren’s syndrome: A systematic review from the Italian society of rheumatology. Autoimmun Rev. (2020) 19:102447. doi: 10.1016/j.autrev.2019.102447 - DOI - PubMed

Publication types

LinkOut - more resources