Allogeneic Cultured Keratinocytes and Fibroblasts

Allogeneic Cultured Keratinocytes and Fibroblasts is an allogeneic cellularized scaffold product used for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).

• Allogeneic Cultured Keratinocytes and Fibroblasts are available under the following different brand names: StrataGraft, allogeneic cultured keratinocytes, and dermal fibroblasts in murine collagen-dsat.

Common side effects of Allogeneic Cultured Keratinocytes and Fibroblasts include:

• itching (pruritus)
• blisters
• hypertrophic scar 
• impaired healing

Serious side effects of Allogeneic Cultured Keratinocytes and Fibroblasts include:

• not available

Rare side effects of Allogeneic Cultured Keratinocytes and Fibroblasts include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Topical bioengineered skin graft

• Each rectangular sheet approximately 100 cm2 (approximately 8cm x 12.5cm)

Burns

Adult dosage

• Surgically apply to prepared wound bed following excision/debridement
• Construct is approximately 100 cm2 (approximately 8 cm x 12.5 cm) off-white rectangle; may trim construct to fit shape and size of wound area
• The surface area of the construction should be equal to the surface area of the wound to be treated
• Multiple constructs may be applied to cover large wound areas
• If multiple constructs are required, about its constructs; not necessary to overlap edges
• Each construct is for a single patient only

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Allogeneic Cultured Keratinocytes and Fibroblasts has severe interactions with no other drugs
• Allogeneic Cultured Keratinocytes and Fibroblasts has serious interactions with the following drugs:
  • chlorhexidine topical
  • mafenide
  • silver nitrate
  • silver sulfadiazine
• Allogeneic Cultured Keratinocytes and Fibroblasts has moderate interactions with no other drugs
• Allogeneic Cultured Keratinocytes and Fibroblasts has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known allergies to murine collagen or products containing ingredients of bovine or porcine origin

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Allogeneic Cultured Keratinocytes and Fibroblasts?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Allogeneic Cultured Keratinocytes and Fibroblasts?”

Cautions

• Contains glycerin; avoid in patients with known sensitivity
• Severe hypersensitivity reactions may occur; monitor for both early and late symptoms and signs following application; treat according to standard medical practice
• Donation of blood, organs, tissues, or cells
• Recipients of xenotransplantation are generally not eligible to donate whole blood or blood components, including plasma and source leukocytes
• However, individual blood collection establishments may request an exception
• Recipients who otherwise meet donor requirements are eligible to donate human cells, tissues, cellular or tissue-based products (HCT/Ps), human milk, ova, sperm, or organs for transplantation
• Transmission of infectious diseases
  • Contains cells from human donors and may transmit infectious diseases or infectious agents, such as viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD] or variant CJD)
  • Classified as a xenotransplantation product because of historic exposure of the keratinocyte cells to well-characterized mouse cells
  • Cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are no longer used in the manufacture of StrataGraft; however, these measures do not eliminate the risk of transmitting infectious diseases and disease agents
  • Transmission of infectious diseases or agents has not been reported
• Drug interaction overview
  • Mafenide
    • Not recommended
    • Mafenide acetate, a topical antimicrobial, reduces keratinocyte viability and disrupts the integrity of tissue-engineered human skin substitutes composed of keratinocytes
  • Silver-containing antimicrobials and dressings
    • Not recommended
    • Data suggest silver may decrease the viability of keratinocytes and human dermal fibroblasts
  • Chlorhexidine
    • Not recommended
    • Chlorhexidine topical antiseptic shown to be toxic to keratinocytes and human dermal fibroblasts

Pregnancy and Lactation

• There are no available data regarding use in pregnant women
• No animal reproductive and developmental toxicity studies have been conducted to assess whether it can cause fetal harm
• Lactation
  • Data are unavailable on the presence of human milk, its effect on breastfed infants, or its effect on milk production