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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 an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

Limitations of Use

Effectiveness of MACI in joints other than the knee has not been established.

Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

Important safety information

Contraindications: MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, products of porcine or bovine origin; in patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders; in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant; or in patients unable to cooperate with a physician-prescribed post-surgical rehabilitation program.
 

Warnings and Precautions:

  • Malignancy: The risk of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation may be possible.
  • Transmissible infectious diseases: Because patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases, cartilage biopsy and MACI implant may carry risk of transmitting infectious diseases.
  • Presurgical Comorbidities: Local inflammation or active infection in the bone, joint, and surrounding soft tissue, meniscal pathology, cruciate ligament instability, and misalignment should be assessed and treated prior to or concurrent with MACI implantation.
  • Product Sterility: Final sterility test results are not available at the time of shipping.
     

Adverse Reactions: The most frequently occurring adverse reactions reported for MACI (≥5%) were arthralgia, tendonitis, back pain, joint swelling, and joint effusion. Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.
 

Specific Populations:

  • Use of MACI in pediatric patients (younger than 18 years of age) or in patients over 65 years of age has not been established.
  • The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breastfeeding to an infant has not been determined.
     

To report negative side effects, contact Vericel Corporation at 1-800-453-6948 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
 

Please see Full Prescribing 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 and pediatric patients 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 and pediatric patients 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
  • Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal

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. If a hypersensitivity reaction occurs, remove NEXOBRID (if applicable) and initiate appropriate therapy.
Healthcare personnel should take appropriate precautions to avoid exposure when preparing and handling NEXOBRID (e.g., gloves, surgical masks, other protective coverings, as needed).

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 (>5%) in adults were pruritus, pyrexia, wound complication, anemia, vomiting and insomnia. The most common adverse reactions (>5%) in pediatric patients were pruritus, pyrexia and vomiting.

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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