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临床中的干细胞疗法。

Stem cell therapies in the clinic.

作者信息

Acharya Shrinivas, Shaha Suyog, Bibbey Michael Griffith, Mukherji Malini, Zhao Zongmin, Mitragotri Samir

机构信息

John A. Paulson School of Engineering and Applied Sciences Harvard University Massachusetts USA.

Wyss Institute for Biologically Inspired Engineering Harvard University Boston Massachusetts USA.

出版信息

Bioeng Transl Med. 2025 Feb 4;10(3):e70000. doi: 10.1002/btm2.70000. eCollection 2025 May.

DOI:10.1002/btm2.70000
PMID:40385529
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12079495/
Abstract

Stem cell therapies have emerged as a transformative approach in modern medicine, with the potential to address and possibly cure a broad spectrum of diseases. These therapies utilize living stem cells that can perform complex biological functions not replicable by traditional drugs. Stem cell therapies have an expanding therapeutic landscape, with several products already approved and numerous clinical trials underway. Among the various stem cell types, hematopoietic stem cells (HSCs) and mesenchymal stem cells (MSCs) are most widely studied. In this review, we provide a detailed analysis of the current clinical landscape of stem cell therapies. We review 27 stem cell products that have received regulatory approvals and discuss 800 ongoing clinical trials, with a focus on HSCs and MSCs. We also discuss the critical challenges to be addressed to facilitate the clinical translation of stem cell therapies.

摘要

干细胞疗法已成为现代医学中一种变革性的方法，具有解决并可能治愈多种疾病的潜力。这些疗法利用活的干细胞，其能够执行传统药物无法复制的复杂生物学功能。干细胞疗法的治疗领域正在不断扩大，已有数种产品获批，并且有大量临床试验正在进行。在各种干细胞类型中，造血干细胞（HSCs）和间充质干细胞（MSCs）的研究最为广泛。在本综述中，我们对干细胞疗法的当前临床情况进行了详细分析。我们回顾了27种已获得监管批准的干细胞产品，并讨论了800项正在进行的临床试验，重点关注造血干细胞和间充质干细胞。我们还讨论了为促进干细胞疗法的临床转化需要解决的关键挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/40d280e216ac/BTM2-10-e70000-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/0789089a0317/BTM2-10-e70000-g008.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/73709d62c11b/BTM2-10-e70000-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/4a9488f5b66b/BTM2-10-e70000-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/76cc27ad3b77/BTM2-10-e70000-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/5684bad388c3/BTM2-10-e70000-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/e7f5c4fda274/BTM2-10-e70000-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/40d280e216ac/BTM2-10-e70000-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/0789089a0317/BTM2-10-e70000-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/1c636803c029/BTM2-10-e70000-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/73709d62c11b/BTM2-10-e70000-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/4a9488f5b66b/BTM2-10-e70000-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/76cc27ad3b77/BTM2-10-e70000-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/5684bad388c3/BTM2-10-e70000-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/e7f5c4fda274/BTM2-10-e70000-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc40/12079495/40d280e216ac/BTM2-10-e70000-g006.jpg

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本文引用的文献

1
Immunogenicity of mesenchymal stromal/stem cells.间充质基质/干细胞的免疫原性。
Scand J Immunol. 2023 Jun;97(6):e13267. doi: 10.1111/sji.13267. Epub 2023 Apr 3.
2
Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial.自体或异体脂肪间充质基质细胞联合磷酸三钙生物材料用于治疗长骨萎缩性骨不连的手术治疗的疗效和安全性：一项 II 期临床试验。
J Transl Med. 2024 May 24;22(1):493. doi: 10.1186/s12967-024-05280-x.
3
Induced pluripotent stem cells (iPSCs): molecular mechanisms of induction and applications.
诱导多能干细胞（iPSCs）：诱导的分子机制与应用。
Signal Transduct Target Ther. 2024 Apr 26;9(1):112. doi: 10.1038/s41392-024-01809-0.
4
Mapping the global landscape for induced pluripotent stem cells from patents and clinical trials.通过专利和临床试验描绘诱导多能干细胞的全球发展态势。
Nat Biotechnol. 2024 Apr;42(4):563-569. doi: 10.1038/s41587-024-02196-1.
5
Regenerative treatment of ophthalmic diseases with stem cells: Principles, progress, and challenges.干细胞在眼科疾病中的再生治疗：原理、进展与挑战
Adv Ophthalmol Pract Res. 2024 Feb 28;4(2):52-64. doi: 10.1016/j.aopr.2024.02.001. eCollection 2024 May-Jun.
6
Locoregional drug delivery for cancer therapy: Preclinical progress and clinical translation.癌症治疗的局部药物递送：临床前进展和临床转化。
J Control Release. 2024 Mar;367:737-767. doi: 10.1016/j.jconrel.2024.01.072. Epub 2024 Feb 14.
7
The heterogeneity of mesenchymal stem cells: an important issue to be addressed in cell therapy.间充质干细胞的异质性：细胞治疗中需要解决的一个重要问题。
Stem Cell Res Ther. 2023 Dec 20;14(1):381. doi: 10.1186/s13287-023-03587-y.
8
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Cytotherapy. 2024 May;26(5):413-417. doi: 10.1016/j.jcyt.2023.09.001. Epub 2023 Oct 7.
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Stem Cells Transl Med. 2023 Dec 18;12(12):775-782. doi: 10.1093/stcltm/szad060.
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Smart Strategies to Overcome Drug Delivery Challenges in the Musculoskeletal System.克服肌肉骨骼系统给药挑战的明智策略
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