Collagen Type I

Uses

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

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 .

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 . Other products using bovine type 1 collagen include PriMatrix, Integra, Orcel and Matriderm .

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 .

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 .

Collagen Type I is also used to associated treatment for these conditions: Wound of the Oral Cavity, Nutritional supplementation

How Collagen Type I works

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 .

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 . Bovine collagen is used most frequently out of naturally-sourced collagen, due to its biocompatibility with human beings .

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

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 .

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 . 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 , .

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) . 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 . 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 .

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 .

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 .

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