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Stem cell-based therapies for type 1 diabetes: Progress in differentiation, clinical translation, and immune protection
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Zifan Li1, 2, Yu Kang1, 2, Yuyu Niu1, 2, 3
Animal Models and Experimental Medicine | 2026, 9(7) : 1277 - 1291
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Animal Models and Experimental Medicine | 2026, 9(7): 1277-1291
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Stem cell-based therapies for type 1 diabetes: Progress in differentiation, clinical translation, and immune protection
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Zifan Li1, 2, Yu Kang1, 2, Yuyu Niu1, 2, 3
Affiliations
  • 1State Key Laboratory of Primate Biomedical Research; Institute of Primate Translational Medicine, Kunming University of Science and Technology, Kunming, Yunnan, China
  • 2Yunnan Key Laboratory of Primate Biomedical Research, Kunming, Yunnan, China
  • 3Southwest United Graduate School, Kunming, Yunnan, China
Published: 2026-07-28 doi: 10.1002/ame2.70211
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Transplantation of insulin-producing cells derived from pluripotent stem cells represents a highly promising approach for the radical treatment of type 1 diabetes (T1D). Informed by a comprehensive understanding of fetal pancreatic development, directed differentiation protocol for generating pancreatic β cells from pluripotent stem cells has been established and has achieved considerable advances, enabling the production of mature, fully functional β cells that closely recapitulate the characteristics of native pancreatic β cells. Preclinical studies have shown that the transplantation of stem cell-derived islets (SC-islets) reverses hyperglycemia in both mouse and nonhuman primate models, with a favorable safety profile. Early-phase clinical trials have further corroborated the safety and efficacy of this approach, a subset of patients with long-standing T1D achieved insulin independence, described as a "functional cure", with no serious adverse events of clinical significance reported. Despite these encouraging results, substantial challenges remain. With respect to differentiation protocols, insufficient functional maturity, pronounced cellular heterogeneity, significant batch-to-batch variability, and the challenges of large-scale manufacturing represent the principal unresolved limitations. Of particular concern, immune rejection remains a critical barrier even after the transplantation of autologous SC-islets, necessitating continued reliance on immunosuppressive therapy. Cell encapsulation and gene editing strategies have emerged as potential approaches to overcome this immunological barrier. In this review, we discuss strategies for obtaining insulin-producing cells from diverse cellular sources, summarize the latest advances in stem cell-based diabetes therapy, and propose future research directions.

immune rejection  /  islet organoids  /  stem cell therapy  /  type 1 diabetes  /  β cells
Zifan Li, Yu Kang, Yuyu Niu. Stem cell-based therapies for type 1 diabetes: Progress in differentiation, clinical translation, and immune protection[J]. Animal Models and Experimental Medicine, 2026 , 9 (7) : 1277 -1291 . DOI: 10.1002/ame2.70211
  • National Key R&D Program of China(2021YFA0805700; 2021YFA1102000)
  • National Natural Science Foundation of China(U2102204)
  • Natural Science Foundation of Yunnan Province(202102AA100053; 202403AH310053)
  • Xingdian Talent Support Plan of Yunnan Province, China(202405AB350001)
Year 2026 volume 9 Issue 7
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57
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Article Info
doi: 10.1002/ame2.70211
  • Receive Date:2025-12-24
  • Online Date:2026-08-06
  • Published:2026-07-28
Article Data
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History
  • Received:2025-12-24
  • Revised:2026-03-25
  • Accepted:2026-04-01
Funding
National Key R&D Program of China(2021YFA0805700; 2021YFA1102000)
National Natural Science Foundation of China(U2102204)
Natural Science Foundation of Yunnan Province(202102AA100053; 202403AH310053)
Xingdian Talent Support Plan of Yunnan Province, China(202405AB350001)
Affiliations
    1State Key Laboratory of Primate Biomedical Research; Institute of Primate Translational Medicine, Kunming University of Science and Technology, Kunming, Yunnan, China
    2Yunnan Key Laboratory of Primate Biomedical Research, Kunming, Yunnan, China
    3Southwest United Graduate School, Kunming, Yunnan, China

Corresponding:

Yuyu Niu, State Key Laboratory of Primate Biomedical Research; Institute of Primate Translational Medicine, Kunming University of Science and Technology, Kunming 650500, Yunnan, China. Email:
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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