ECM Biomaterial

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ECM biomaterials are a class of biomaterials derived from processing human or animal tissues to retain portions of the extracellular matrix. These materials are typically cell-free, distinguishing them from classical allografts and xenografts, can be integrated or incorporated into the body, and have been FDA approved for human use for more than 10 years in a wide range of clinical indications.[1]


Classic Tissue Engineering and Regenerative Medicine research combines cells and scaffolds, induced to grow with biochemical and mechanical stimuli, in a laboratory setting for organ repair and replacement. Due to complexities in bringing a successful tissue engineered organ to market, only limited clinically available devices meet this classic definition (for example: artificial skin, sold for limited indications in the healing of venous leg and diabetic foot ulcers.[2]) However, the approach of implanting cell-free scaffolds, with or without growth factors has become a regular part of clinical practice in healing patients in a wide range of applications including, but not limited to, hernia repair,[3] skin and wound healing,[4] breast reconstruction,[5][6] tendon repair,[7] and bone healing.[8] ECM biomaterials are derived from the extracellular matrix of human or animal tissues, and processed to remove unwanted components of the tissues and retaining desired components. Versions of these materials have been on the FDA approved since 1996 for soft tissue repair devices,[9] and 1991 for demineralized bone grafts.[10]



  1. ^ Cornwell, K.G., Landsman, A., James, K.S. Extracellular Matrix Biomaterials for Soft Tissue Repair. Clin Podiatr Med Surg 26 (2009) 507–523 (Original Article)
  2. ^ Apligraf, artificial skin manufactured by Organogenesis Inc.(Apligraf Website)
  3. ^ Dr. N. Joseph Espat Presented Positive Clinical Results on the Use of Biologics for Abdominal Wall Reconstruction in Chemotherapy Patients, Reuters Business Wire, Mon Jun 29, 2009 8:30am EDT (Reuters Article)
  4. ^ Jones, I., Currie, L., Martin, R., A guide to biological skin substitutes. JPRAS. V55:3, Pgs 185-193 2002 doi:10.1054/bjps.2002.3800
  5. ^ Patient Information on Single Stage Breast Reconstruction,, Carlo Press Publications (Web Article)
  6. ^ Breast reconstruction advances fix distortions left by lumpectomy,, April 23rd, 2008.(Web Article, Source: American Society of Plastic Surgeons)
  7. ^ Coons, D.A. and Barber, A.F. Tendon graft substitutes-rotator cuff patches 14(3):185-90. 2006.Original Article
  8. ^ Boden, S.D. Bone Graft Substitutes for Spine Fusion (Web Article)
  9. ^ FDA 510k for Supple Peri-Guard, Bio-vascular Inc., 1996 (FDA 510k letter)
  10. ^ according to Osteotech Inc., manufacturer of Grafton
  11. ^ Alloderm, manufactured by Lifecell
  12. ^ SurgiMend and PriMatrix, manufactured by TEI Biosciences Inc.
  13. ^ FDA 510k, Permacol
  14. ^ Grafton, manufactured by Osteotech Inc. FDA 510K, Grafton
  15. ^ FDA 510k, Orthadapt
  16. ^ FDA 510k, Supple Peri-Guard
  17. ^ Chitin Scaffolds in Tissue Engineering
  18. ^ Tissue Engineering: From Cell Biology to Artificial Organs,p163