NAV

Bovine type I collagen

Identification

Summary

Bovine type I collagen is a collagen gel derived from cows used to treat a wide variety of wounds, as well as a supplement for bones and joints.

Brand Names
Gintuit
Generic Name
Bovine type I collagen
DrugBank Accession Number
DB10771
Background

Bovine collagen alpha-1 is a naturally occurring extracellular matrix protein which is found in tendons and other connective tissues. It plays a vital role in cell growth, differentiation, attachment, and migration 9. Often combined with other ingredients, such as fibroblasts and keratinocytes, it allows for accelerated and effective wound healing 11, 10.

Excellagen, a topical gel of bovine type I collagen, is used in the management of wounds including: partial and full- thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds 24.

Bovine type I collagen is also used as a health supplement for bones and joints 5.

Interestingly, bovine type I collagen has been studied as a possible endovascular stent material, and has demonstrated promising results in rabbits 3.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Collagen Type I, Bovine

Pharmacology

Indication

For the management of wounds including: partial and full- thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh’s dermatological surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds 24.

Gintuit (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. It uses bovine collagen as a matrix to support the growth of keratinocytes and fibroblasts in wound healing 10. Other products using bovine type 1 collagen include PriMatrix, Integra, Orcel and Matriderm 17.

Orcel is a bilayered cellular matrix in which normal human allogeneic skin cells (both epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge, indicated in venous leg ulcers and diabetic foot. Type I bovine collagen acts as a matrix for the growth and proliferation of fibroblasts and keratinocytes, offering structure and support 11.

In the laboratory, bovine Collagen Type I purified protein standard is used as a control for SDS-PAGE, Western Blot, ELISA, immunoprecipitation, and for other immunological assays 15.

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Associated Conditions
Associated Therapies
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Pharmacodynamics

Collagen-based ingredients are very important for tissue engineering and regenerative medicine because of its superior human biocompatibility and low immunogenicity 19.

Bovine Collagen Type I belongs to a family of proteins found particularly in the flesh and connective tissues of mammals (approximately 1/3 of the body's total protein). More than two dozen types of collagen have been discovered; Type I is the most abundant form in the body. This type of collagen is found in scar tissue, tendons, the skin, arterial wall, the cornea, muscles, cartilage, and in certain parts of bones and teeth. Bovine Collagen Type I is ideal for investigators studying in extracellular matrix proteins and osteoporosis 15.

Type I collagen is the primary organic component of the extracellular matrix in the bone and can play an imperative role in bone tissue engineering. Type I collagen (bovine) is the basis of several laboratory and pharmaceutical products including Collapat II, Healos, Collagraft, and Biostite, among others 16.

Mechanism of action

Collagen is a fibrillar protein that forms the conjunctive and connective tissues in the human body, including the skin, joints, and bones. This molecule is one of the most predominant in many living organisms, owing to its connective role in biological structures 19.

Collagen as a general substance is the most abundant structural protein in the human body that provides support to numerous tissues such as tendons, skin, and teeth (collagen joined to mineral crystals). All proteins that have a structure based on three helix structured polypeptidic chains 19. Bovine collagen is used most frequently out of naturally-sourced collagen, due to its biocompatibility with human beings 19.

When applied to a wound surface, bovine type I collagen absorbs wound fluid and maintains a moist wound environment, which is optimal for healing 14.

Numerous studies have demonstrated that the use of type I collagen matrices is capable of promoting osteogenic differentiation and mineralization of marrow stromal cells as well as human adipose stem cells. Another study demonstrated that a collagen scaffold (Gingistat) is appropriate for supporting the distribution of cells to form bone tissue 16.

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Elevated anti-collagen antibody levels have been detected in patients treated with clinical doses of injectable collagen, even in the absence of adverse cutaneous reactions 4. Antibodies to both native type I bovine and human collagen can lead to a variety of symptoms including joint inflammation, edema at the injection site of bovine collagen implant and fever, as late as 6 months after injection 7, 8.

Products derived from bovine tissues, especially gelatine, tallow and dicalcium phosphate have been studied in relation to bovine spongiform encephalopathy (BSE) and Creutzfeld-Jacob disease (CJD) 5. The risk of BSE and CJD is dependent on many factors, including the country of origin of the bovine collagen, the health of the cattle from which the collagen is obtained, and practices during processing. Denaturation temperature is a particularly important parameter, depending on the collagen origin and hydration level 6. According to the World Health Organization (WHO), prolonged alkaline treatment, filtration, and heat sterilization (≥ 138o C for ≥ 4 sec) or an equivalent process on gelatin is a safe practice in preventing BSE 22.

The collagen manufacturing process may have some steps in common with the manufacture of gelatin such as alkaline and sodium sulfate treatment, calcium hydroxide and sodium hydroxide treatments or enzyme treatment. These common steps can, however, differ in duration and pH condition which can result in significant differences in their prion inactivation capacity. Manufacturers should at least conduct a process evaluation based on the similarities of the collagen processing steps, as compared to known inactivation steps in the manu­facture of gelatin, to support the safety of the product. Outside of the processing steps, differences also exist in the final use of the material and, as a result, in their risk assessment, while gelatin is widely used for oral administration, many collagen applications are in the form of implants. This should be considered in the final risk assessment of type I bovine collagen products 23.

According to the EMA (European medicines agency), collagen produced from tissues such as hides, skins, tendons, and sinews do not usually present a measurable TSE risk provided that contamination with potentially infected materials, for example, spillage of blood and/or central nervous tissues, is avoided during procurement. Hides represent a safer raw material for human implants derived from collagen. However, cross-contamination with brain material released during the slaughtering process, possibly dried on the surface of hides is difficult to eliminate. This is another aspect to consider in the evaluation of the safety of bovine type I collagen 22.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.

Products

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
GintuitBovine type I collagen + Foreskin fibroblast (neonatal) + Foreskin keratinocyte (neonatal)Cellular SheetTopicalOrganogenesis2012-03-15Not applicableUS flag

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans

Chemical Identifiers

UNII
FHJ3ATL51C
CAS number
9050-08-2

References

General References
  1. Rudnick A: Advances in tissue engineering and use of type 1 bovine collagen particles in wound bed preparation. J Wound Care. 2006 Oct;15(9):402-4. doi: 10.12968/jowc.2006.15.9.26962. [Article]
  2. Song H, Zhang S, Zhang L, Li B: Effect of Orally Administered Collagen Peptides from Bovine Bone on Skin Aging in Chronologically Aged Mice. Nutrients. 2017 Nov 3;9(11). pii: nu9111209. doi: 10.3390/nu9111209. [Article]
  3. Cloft HJ, Kallmes DF, Lin HB, Li ST, Marx WF, Hudson SB, Helm GA, Lopes MB, McGraw JK, Dion JE, Jensen ME: Bovine type I collagen as an endovascular stent-graft material: biocompatibility study in rabbits. Radiology. 2000 Feb;214(2):557-62. doi: 10.1148/radiology.214.2.r00fe21557. [Article]
  4. Aragona F: [Is bovine collagen safe?]. J Urol (Paris). 1991;97(6):279-81. [Article]
  5. Dar QA, Schott EM, Catheline SE, Maynard RD, Liu Z, Kamal F, Farnsworth CW, Ketz JP, Mooney RA, Hilton MJ, Jonason JH, Prawitt J, Zuscik MJ: Daily oral consumption of hydrolyzed type 1 collagen is chondroprotective and anti-inflammatory in murine posttraumatic osteoarthritis. PLoS One. 2017 Apr 6;12(4):e0174705. doi: 10.1371/journal.pone.0174705. eCollection 2017. [Article]
  6. Gauza-Wlodarczyk M, Kubisz L, Mielcarek S, Wlodarczyk D: Comparison of thermal properties of fish collagen and bovine collagen in the temperature range 298-670K. Mater Sci Eng C Mater Biol Appl. 2017 Nov 1;80:468-471. doi: 10.1016/j.msec.2017.06.012. Epub 2017 Jun 22. [Article]
  7. Bonnet C, Charriere G, Vaquier J, Bertin P, Vergne P, Treves R: Bovine collagen induced systemic symptoms: antibody formation against bovine and human collagen. J Rheumatol. 1996 Mar;23(3):545-7. [Article]
  8. Hyder P, Singh G, Adam S: Humoral responses to type I collagen after surgical curettage procedures employing bovine collagen implants. Biomaterials. 1992;13(10):693-6. [Article]
  9. Computational analysis of bovine alpha-1 collagen sequences [Link]
  10. Gintuit [Link]
  11. SUMMARY OF SAFETY AND EFFECTIVENESS DATA, Orcel [Link]
  12. Advances in Skin Substitutes—Potential of Tissue Engineered Skin for Facilitating Anti-Fibrotic Healing [Link]
  13. Development and utilization of a bovine type I collagen microfibril model [Link]
  14. CoMatryx wound dressing, FDA letters and documents [Link]
  15. Bovine Collagen Type I [Link]
  16. Type 1 Collagen [Link]
  17. Scielo [Link]
  18. A Bovine Collagen Type I-Based Biodegradable Matrix as a Carrier for Tissue-Engineered Urothelium [Link]
  19. Collagen: A review on its sources and potential cosmetic applications [Link]
  20. Bovine type 1 Collagen, Santa Cruz Biology [Link]
  21. Updated Report and Scientific Opinion on the safety of hydrolysed proteins produced from bovine hides. Initially adopted by the Scientific Steering Committee at its meeting of 22-23 October 1998 and updated at its meeting of 25-26 May 2000 [Link]
  22. WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies [Link]
  23. Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3) [Link]
  24. Excellagen [Link]
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Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2CompletedTreatmentConnective Tissue Disorders / Scleroderma1
1, 2TerminatedTreatmentEdentulous Alveolar Ridge1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
CapsuleOral
Cellular sheetTopical
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at December 01, 2015 20:04 / Updated at May 21, 2021 10:21