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Advanced Therapies

Vericel markets three products in the U.S.

MACI | See Dara's Story
MACI

The U.S. Food and Drug Administration has approved MACI (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. MACI is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. Chronic knee pain affects millions of people across the U.S., but often goes untreated for long periods of time. Knee cartilage damage can occur from acute or repetitive trauma from playing sports, exercising, work-related physical demands, or performing everyday activities. A 2019 survey that Vericel conducted with The Harris Poll, found that 77% of chronic knee pain sufferers can no longer participate in at least one activity they enjoy because of their pain. While 74% of those with knee pain hope that their symptoms will resolve without treatment, knee cartilage does not heal on its own, and if left untreated, cartilage defects can progress. Learn More >

Indication and Important Safety Information

Indication

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is made up of your own (autologous) cells that are expanded and placed onto a film that is implanted into the area of the cartilage damage and absorbed back into your own tissue.

MACI is used for the repair of symptomatic cartilage damage of the adult knee.

The amount of MACI applied depends on the size of the cartilage damage. The MACI film is trimmed by your surgeon to match the size and shape of the damage, to ensure the damaged area is completely covered.

Limitations of Use

It is not known whether MACI is effective in joints other than the knee.

It is not known whether MACI is safe or effective in patients over the age of 55 years.

Important safety information

MACI should not be used if you:

  • are allergic to antibiotics such as gentamicin, or materials that come from cow, pig, or ox;
  • have severe osteoarthritis of the knee, other severe inflammatory conditions, infections or inflammation in the bone joint and other surrounding tissue, or blood clotting conditions;
  • have had knee surgery in the past 6 months, not including surgery for obtaining a cartilage biopsy or a surgical procedure to prepare your knee for a MACI implant;
  • or cannot follow a doctor-prescribed rehabilitation program after your surgery

Consult your doctor if you have cancer in the area of the cartilage biopsy or implant as the safety of MACI is not known in those cases.

Conditions that existed before your surgery, including meniscus tears, joint or ligament instability, or alignment problems should be evaluated and treated before or at the same time as the MACI implant.

MACI is not recommended if you are pregnant.

MACI has not been studied in patients younger than 18 or over 55 years of age.

Common side effects include joint pain, tendonitis, back pain, joint swelling, and joint effusion.

More serious side effects include joint pain, cartilage or meniscus injury, treatment failure, and osteoarthritis.

 

Please see Full Prescribing Information for more information.

Epicel | See Mark's Story
Epicel

Epicel is a cultured epidermal autograft (CEA)—a skin graft grown from a patient’s own skin. These grafts provide skin replacement for patients who have deep dermal or full thickness burns comprising a total body surface area (TBSA) of greater than or equal to 30%. From two postage stamp-sized biopsies, Vericel can grow enough skin to cover the patient’s entire body. Epicel is indicated for use in adult and pediatric patients who have deep dermal or full thickness burns comprising ≥ 30% total body surface area (TBSA). According to statistics kept by the American Burn Association, there are approximately 40,000 hospitalizations for burn injury per year, and of those approximately 10% (4000 patients) are admitted to hospitals with TBSA ≥30% (percentage derived from American Burn Association, Burn Injury Summary Report 2021). Therefore, the annual incidence reassessment (AIR) for the indicated use is assumed to be approximately 4000 patients. Learn more >

Indication and Important Safety Information

Humanitarian Device

Epicel (cultured epidermal autografts) is authorized for use in adults and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. The effectiveness of the device for this use has not been demonstrated.

Important Safety Information

Epicel is contraindicated in patients with a history of anaphylaxis following exposure to vancomycin, amikacin, and amphotericin, as trace quantities of these anti-infective agents may remain in the Epicel autograft. Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. It is contraindicated for use on clinically infected wounds.

Because Epicel is manufactured with and contains residual amounts of murine cells, FDA considers it a xenotransplantation product. Therefore, recipients should not donate whole blood, blood components, source plasma, source leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans because there is a potential risk of carrying an infection that is transmitted from mouse cells to humans.

Squamous cell carcinoma (SCC) has been reported in patients with burn injury after being grafted with Epicel. Although SCC is a known complication of burn scars, the role of Epicel in the causation of SCC cannot be excluded.

The Epicel product is intended solely for autologous use. Patients undergoing the surgical procedure associated with Epicel are not routinely tested for transmissible infectious diseases. Discontinue use if the patient shows evidence of allergic reaction.

If clinical signs of infection are present or develop, do not apply Epicel until the infection is adequately treated.

The effectiveness of Epicel has not been proven in clinical studies.

The long-term safety of Epicel is unknown. Over the past 27 years, the mortality from all causes was 13% before hospital discharge.

Men and women who intend to have children should be advised tat the effects, if any, of Epicel on fetal development have not been assessed. In addition, the safety of Epicel has not been studied in pregnant and nursing women.

Patient information supplied by attending burn teams from 1989 to 1996 reported the adverse events of highest incidence as: death (13%), infection (13.8%), graft tear (7.8%) or graft blister (4.2%) and drainage (3.3%). Some of these events may have been due to the underlying burn injury and not the device itself.

From June 1998 through September, 2015 adverse events received by Genzyme Biosurgery (predecessor in interest to Vericel) and Vericel Corporation were similar to the previously identified adverse events. Events that were reported in ≥ 1% of patients included multi-organ failure (6.6%), sepsis (5.2%) infection (4%) and skin graft failure/graft complication (2.7%). The relationship of these events to Epicel has not been established.

 

Please see Patient Information and Directions for Use for more information

Epicel

NexoBrid is a botanical drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. A critical first step in the treatment of partial- and full-thickness burns is the rapid removal of nonviable burned tissue. Eschar removal involves removing layers of dead tissue from a burn wound. Following topical application of NexoBrid to burn eschar, a dressing is placed over the treatment area. After four hours, the eschar is removed and the wound bed is cleaned to make an assessment including burn depth, color implications and bleeding patterns. Learn more >

Indication and Important Safety Information

Indication

NexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for treatment of:

  • Chemical or electrical burns
  • Burns on the face, perineum, or genitalia

  • Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease

  • Circumferential burns

  • Burns in  patients with significant cardiopulmonary disease, including inhalation injury

NEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.

Important Safety Information

CONTRAINDICATIONS

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

WARNINGS AND PRECAUTIONS

Hypersensitivity reactions

Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of anacaulase-bcdb.

Pain Management

Manage pain as appropriate for an extensive dressing change of burn wounds. At least 15 minutes prior to NEXOBRID-related procedures ensure adequate pain control measures are in place.

Proteolytic Injury to Non-Target Tissues

NEXOBRID is not recommended for treatment of burn wounds where medical devices or vital structures could become exposed during eschar removal.

Coagulopathy

Avoid use of NEXOBRID in patients with uncontrolled disorders of coagulation. Use with caution in patients on anticoagulant therapy or other drugs affecting coagulation, and in patients with low platelet counts and increased risk of bleeding from other causes. Monitor patients for possible signs of coagulation abnormalities and signs of bleeding.

ADVERSE REACTIONS

The most common adverse reactions (>10%) were pruritus and pyrexia.

USE IN SPECIAL POPULATIONS

Geriatric Use

Clinical studies of NEXOBRID did not include sufficient numbers of subjects  65 years of age and older to determine whether they respond differently from younger adult subjects.

To report negative side effects contact Vericel Corporation at 888-454-BURN (888-454-2876) or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

 

Please see Full Prescribing Information.

Patents

This section is intended to serve as notice under 35 U.S.C. § 287(a) of various United States patents associated with the products listed. The products and patent numbers shown may not be all-inclusive. Other patents may protect both the products listed and other products commercialized by Vericel Corporation. Additional patents are pending.

Granted patents and published U.S. patent applications may be viewed at the United States Patent and Trademark Office website.

Published international patent applications may be viewed at the World Intellectual Property Organization website.

MACI

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