PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
No reports describing the use of azficel-T in human pregnancy have been located.
Because it is an autologous product that is obtained from the patient by skin biopsy, reproduction studies in animals have not been conducted. The risk to an embryo or fetus appears to be nil.
FETAL RISK SUMMARY
Azficel-T is an autologous cellular product composed of dermal fibroblasts suspended in a sterile medium. The fibroblasts are obtained from postauricular skin biopsy tissue and sent to the manufacturer for aseptic expansion using standard tissue culture procedures. The cells are shipped back to the clinic when sufficient cells for three doses have been obtained and when patient administration has been scheduled. The product is given as three intradermal injections at 3- to 6-week intervals. Azficel-T is indicated for improvement of the appearance of moderate-to-severe nasolabial fold wrinkles in adults (1). Information on metabolism, plasma protein binding, and half-life is not relevant.
Studies in animals or by other means have not been conducted for reproduction, carcinogenicity, mutagenicity, and fertility.
Because the cells are injected intradermal they should not be in the systemic circulation. Moreover, intact cells should not cross the placenta.
No reports describing the use of azficel-T during human lactation have been located. Because the cells are injected intradermal they should not be in the systemic circulation and would not be present in breast milk. Moreover, the product is made from the patient’s own cells and would not be expected to harm a nursing infant.
1.Product information. Laviv. Fibrocell Technologies, 2011.