allogeneic cultured keratinocytes/fibroblasts in bovine collagen

Action and Spectrum

Mechanism of action 

The mechanism of action and spectrum of activity of allogeneic cultured keratinocytes and fibroblasts in bovine collagen needs to be betternderstood. Still, it is thought that the cells may have a trophic effect on the damaged or ulcerated tissue, promoting growth and repair. 

Allogeneic keratinocytes differentiate into various skin cells, such as epidermal keratinocytes, which can form a protective barrier on the skin, thus promoting wound healing. Fibroblasts also play a role in wound healing by promoting the formation of extracellular matrix and collagen, giving the tissue structure and strength. 

The bovine collagen in the product may act as a scaffold, providing a supportive structure for the growth of new tissue. It also allows for the attachment, proliferation, and differentiation of the allogeneic keratinocytes and fibroblasts to repair the damaged area 

Spectrum 

The spectrum of activity of allogeneic cultured keratinocytes and fibroblasts in bovine collagen has been studied primarily in treating oral mucositis and oral lichen planus, which are conditions that cause inflammation and ulceration of the mucous membranes in the mouth. But it has also been used in other skin conditions like burns, wounds, and scarring. 

Drug Interaction

Adverse Reaction

Frequency defined:  

1-10% 

Nasopharyngitis 

Upper respiratory tract infections 

Oral pain 

Facial hypoesthesia 

Sinusitis 

Respiratory tract infections 

Aphthous stomatitis 

Mouth injury 

Black Box Warning

Contraindication / Caution

Contraindications 

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; not intended to provide root coverage. 

Caution 

allogeneic cultured keratinocytes and fibroblasts, derived from the same species but from different individuals, can be combined with bovine collagen to treat various skin conditions such as burns, wounds, and scarring. However, caution should be exercised when using these cells as there is a risk of an immune response or rejection of the cells by the patient’s body. It is important to thoroughly screen the cells for any contaminants or diseases before transplantation and to monitor the patient for any adverse reactions. Additionally, it is essential to use cells that are sourced from healthy animals and are prepared under sterile conditions to minimize the risk of infection. 

Pregnancy / Lactation

Pregnancy consideration: C 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.   

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology 

The allogeneic cultured keratinocytes and fibroblasts in Gintuit are thought to have a similar effect as autologous cells (from the same individual) in that they can differentiate into various skin cells and may promote tissue repair. However, since the cells are from different individuals, there is a risk of an immune response or rejection of the cells by the patient’s body. To minimize this risk, the cells are screened for contaminants or diseases before transplantation, and the product is used under sterile conditions 

Pharmacodynamics 

allogeneic keratinocytes differentiate into various skin cells, such as epidermal keratinocytes, which can form a protective barrier on the skin, thus promoting wound healing. Fibroblasts also play a role in wound healing by promoting the formation of extracellular matrix and collagen, giving the tissue structure and strength. 

The bovine collagen in the product may act as a scaffold, providing a supportive structure for the growth of new tissue. It also allows for the attachment, proliferation, and differentiation of the allogeneic keratinocytes and fibroblasts to repair the damaged area. 

Pharmacokinetics 

Absorption 

The ADME of allogeneic cultured keratinocytes and fibroblasts in bovine collagen needs to be better understood, as it is a relatively new product, and more research is needed. However, it is believed that the product is applied topically to the affected area, and the cells are not expected to be absorbed into the bloodstream or metabolized in the body 

Distribution 

The distribution of the cells and bovine collagen will be limited to the area of application, and the cells are expected to remain at the site of application. They do not migrate to other parts of the body 

Metabolism 

The metabolism of the cells and bovine collagen is not expected to occur, as they are not absorbed into the body 

Elimination/excretion 

The excretion of the cells and bovine collagen is not expected to occur, as they are not absorbed into the body and will eventually be removed by the body’s natural healing process 

Adminstartion

Administration 

allogeneic cultured keratinocytes and fibroblasts are cells taken from one individual and grown in a laboratory. They can then be administered to another individual. In this case, they are being administered in bovine collagen, a protein derived from cows and often used in medical treatments and cosmetic procedures. Allogeneic cultured cells in bovine collagen may be used to treat skin conditions such as burns, wounds, and skin damage. The goal is to promote healing and new, healthy skin formation 

Patient Information Leaflet

Patient information leaflet 

Generic Name: allogeneic cultured keratinocytes/fibroblasts in bovine collagen 

Why do we use allogeneic cultured keratinocytes/fibroblasts in bovine collagen? 

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen can be used as a bioengineered, cellularized scaffold product for treating deep thermal burns. Using allogeneic cells in a murine collagen scaffold, a type of protein derived from mice can provide a viable source of cells for the regeneration of the damaged tissue, promoting healing and reducing scarring. Combining keratinocytes and fibroblasts can also help recreate the natural structure and function of the skin, which is essential for proper healing.