The Main Applications Of Tissue Engineering 組織再生技術應用
Below are the main clinical applications of tissue engineering, covering both approved products and those in clinical research stages.
1. Skin and Wound Repair
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Ovine Forestomach Matrix Dermal Templates (Endoform™)
Based on decellularized ovine forestomach matrix (OFM), Endoform™ Natural and Endoform™ Antimicrobial (with silver ions) are used to treat acute and chronic wounds, including diabetic foot ulcers and venous leg ulcers. Studies show OFM accelerates the healing of diabetic foot ulcers and provides good biocompatibility and regenerative support in hard-to-heal wounds.
2. Articular Cartilage Repair
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MACI® (Matrix-Induced Autologous Chondrocyte Implantation)
MACI is the first FDA-approved autologous cultured chondrocyte scaffold product for repairing full-thickness or multiple cartilage defects in the adult knee. The process involves harvesting healthy cartilage from the patient, expanding the chondrocytes in vitro, seeding them onto a collagen membrane scaffold, and implanting the construct into the defect via arthroscopy or open surgery. Multiple clinical studies and coverage decisions support its safety and efficacy in selected patients.
3. Vascular Grafts and Reconstruction
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Laboratory-Grown Arterial and Venous Grafts
Company Humacyte has developed off-the-shelf, decellularized human vessel grafts by seeding human vascular cells onto a degradable polymer scaffold to create natural-like arteries. Early clinical applications in dialysis and trauma patients have shown reduced complications and host cell repopulation post-implantation. Pending full FDA approval, these grafts could replace traditional synthetic vascular prostheses.
4. Myocardial Repair
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Stem Cell-Derived Cardiac Patches
Cardiac patches derived from pluripotent stem cells have demonstrated potential for treating heart failure in primate studies and a first-in-human trial. These patches are created by differentiating stem cells into cardiomyocytes and fabricating a "patch" that is applied to the heart's surface, improving contractile function and promoting myocardial regeneration over 3–6 months post-implantation.
5. Airway and Tracheal Reconstruction (Research Stage)
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Bioengineered Tracheal Grafts
A few case reports have used decellularized or synthetic scaffolds seeded with autologous cells to replace segments of the trachea, but these approaches remain in early research or single-case report stages and are not yet broadly applied clinically.
6. Bladder and Urinary Tract Reconstruction (Experimental/Case Reports)
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Bioengineered Bladders
In 2006, the Wake Forest team reported reconstructing the bladder of a child with spina bifida using autologous urothelial and smooth muscle cells on a degradable scaffold. Long-term follow-up of up to five years showed tissue integration and functional improvement, but this approach has not yet become a routine commercial product.
Summary and Outlook
To date, FDA-approved or routinely used tissue engineering products focus on skin wound repair, cartilage repair, and vascular grafts. Cardiac patches and bladder reconstructions remain in clinical trials or case-study phases. As 3D/4D bioprinting, smart materials, and extracellular vesicle technologies mature, tissue engineering is expected to expand into complex organ reconstruction, ultimately achieving on-demand, patient-specific living tissues.
以下是組織工程(Tissue Engineering)在臨床上主要的幾類應用,涵蓋已獲批或進入臨床研究階段的技術與產品。
1. 皮膚與傷口修復
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羊胃基質修復膜(Endoform™ Dermal Template)
以去細胞化的羊胃基質(Ovine Forestomach Matrix, OFM)為基礎,Endoform™ Natural 與 Endoform™ Antimicrobial(含銀離子)用於治療急性及慢性創面,包括糖尿病足潰瘍和靜脈性腿部潰瘍。研究顯示,OFM 能加速糖尿病足潰瘍的癒合,並在難愈合創面中展現良好的生物相容性與再生促進效果。
2. 關節軟骨修復
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MACI®(Matrix-Induced Autologous Chondrocyte Implantation)
MACI 是首款經美國 FDA 批准的自體培養軟骨細胞支架產品,用於修復成人膝關節之全層或多發性軟骨缺損。治療流程包括:採集患者健康軟骨組織、體外擴增軟骨細胞,將細胞植入膠原膜支架,然後透過關節鏡或開放手術方式植入缺損部位。多項臨床研究及健保給付決策均支持其在特定患者中的安全性與療效。
3. 血管移植與血管重建
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實驗室培養動靜脈血管
Humacyte 公司開發的離體培養血管,透過在人源血管細胞於可降解高分子支架上種植,製成類似天然動脈的「去細胞」血管。目前正在透析及外傷患者身上進行早期臨床應用,顯示並發症降低,且植入後可被宿主細胞再生。若獲 FDA 最終批准,將可作為現成即用的血管替代品,取代傳統合成移植物。
4. 心肌修復
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幹細胞衍生心肌貼片
由多能幹細胞分化而成的心肌貼片已在靈長類動物研究及首例人體試驗中,展現對心力衰竭的修復潛力。此類貼片將心肌細胞製成可貼敷於心臟表面的「貼片」,在術後 3–6 個月內可改善心臟收縮功能並促進心肌再生。
5. 氣道與氣管重建(研究階段)
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生物支架氣管移植
少數個案報告採用去細胞化或合成支架,結合自體細胞進行氣管替代,但目前仍屬早期研究或單一個案階段,尚未普及臨床應用。
6. 膀胱與尿路重建(實驗與少量臨床報告)
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生物工程膀胱
2006 年,Wake Forest 團隊首次報告使用自體尿路上皮細胞與膀胱平滑肌細胞,結合可降解支架重建脊髓損傷童膀胱之案例。最長 5 年的隨訪顯示組織整合與功能恢復初步成效,但尚未成為常規商業化產品。
小結與展望
迄今為止,真正進入日常臨床或獲 FDA 批准的組織工程產品,主要集中於皮膚創面修復、軟骨修復與血管移植領域;心肌貼片與膀胱重建等仍處於臨床試驗或個案研究階段。隨著 3D/4D 生物列印、智慧材料與細胞外囊泡等技術日益成熟,組織工程有望擴展至更複雜器官的功能重建,最終實現按需列印患者專屬活體組織。