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EPICEL Data

Clinical Experience

A study by Andrew Munster, M.D., of the Baltimore Regional Burn Center of the Johns Hopkins University compared the outcomes of therapy in patients with massive burns with or without cultured epidermal autografts (CEAs). There was found to be a significant reduction in mortality in the CEA group compared with controls, from 48% to 14% (p<.007).¹ Excerpts from the study follow.

From Munster AM. Cultured skin for massive burns: a prospective, controlled trial. Ann Surg 1996.

This published article reported on an independent, physician-sponsored study that compared the outcome of therapy in patients with massive burns with or without cultured epidermal autografts. Two groups of patients were studied over a seven year period. One group received standard care (excision plus allografting and/or split thickness autografting) and the other group received standard care plus EPICEL. All patients for entry into the study had to satisfy the following criteria: 1. a minimum burn size of 50% with a substantial third-degree component, and 2. survival beyond the first operative procedure for excision and initial coverage. Genzyme Biosurgery was able to collect data from the medical records of 44 of the patients in this study. A summary of this data is shown in Table 1.²

Table 1 Available Data from Munster Study

	EPICEL	CONTROL
Number of Patients (n)	20	24
Sex
Male n (%)	15 (75.0)	22 (91.7)
Female n (%)	5 (25.0)	2 (8.3)
Mean 3rd Degree Burn (%)	41.4 ± 20.92	38 ± 25.37
Risk Factors
Mean Age (yrs)	29.6 ± 13	44.0 ± 18.5
Mean Total Body Surface Area (TBSA) (%)	69.1 ± 15.03	62.9 ± 13.16
Inhalation Injury n (%)	18 (90.0)	19 (79.2)
Final Status at 7 years
Survival n (%)	18 (90.0)	9 (37.5)
Death n (%)	2 (10.0)	15 (62.5)

Indication

EPICEL (cultured epidermal autografts) is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater then 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.

Important Safety Information

EPICEL (cultured epidermal autografts) is contraindicated in patients with known hypersensitivity to agents used in the manufacture of EPICEL or with a known history of anaphylaxis to vancomycin amikacin, or amphotericin. EPICEL should not be used in patients with known sensitivites to materials of bovine or murine origin. It is containdicated 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.

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 of the patient shows evidence of allergic reaction.

If clinical signs of infection are present of 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.

Men and women who intend to have children should be advised that 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 (14%), and graft tear (8%) or graft blister (4%). Some of these events may have been due to the underlying burn injury and not the device itself.

From June 1998 through August 2006 adverse events received by Genzyme were similar to the previously identified adverse events. Events that were reported in ≥ 1% of patients included death (9%), sepsis (3.7%) multi-organ failure (3.3%) and skin graft failure/graft complication (1.3%). The relationship of these events to EPICEL has not been established.

References

Munster AM. Cultured skin for massive burns: a prospective, controlled trial. Ann Surg 1996; 224:372–5.
EPICEL Directions for Use; Page 8.

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