Vericel markets three autologous cell therapy products in the U.S.
What is 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.
Knee problems are common, and occur in people of all ages. Cartilage defects in the knee can result from an injury, straining the knee beyond its normal motion, or can be caused by overuse, muscle weakness, and general wear and tear.
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.
MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured. The implantation of MACI is to be performed via an arthrotomy to the knee joint under sterile conditions.
The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect. The implantation membrane is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.
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
MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is also not indicated for use 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.
MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.
The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.
Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue. Universal precautions should be employed when handling the biopsy samples and the MACI product.
Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.
To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI.
Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.
The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.
Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established.
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.
What is Carticel?
Carticel is used to repair articular cartilage injuries in the knee (femoral condyle) in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Carticel is an FDA-approved biologic product that consists of a patient’s own harvested cartilage cells (chondrocytes) which are then multiplied into millions of cells. These autologous cultured chondrocytes are then implanted into the knee cartilage defect in a surgical procedure called autologous chondrocyte implantation (ACI). When implanted, Carticel generates hyaline-like cartilage repair tissue.
Carticel® (autologous cultured chondrocytes) is an autologous cellular product indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft).
Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown.
Carticel is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.
Carticel is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation.
Important Safety Information
Carticel should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.
It should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb.
Pre-existing conditions, including meniscal tears, joint instability, or malalignment should be assessed and treated prior to or concurrent with Carticel implantation.
Carticel is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling Carticel.
Use of Carticel in children, patients over age 65, or in joints other than the knee has not yet been assessed.
The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following Carticel implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to Carticel, during the 4-year follow up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.
What is 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 of greater than or equal to 30%. From 2 postage stamp-sized biopsies, Vericel can grow enough skin to cover the patient’s entire body.