What is alloClae®?
Volume loss is one of the harder problems in aesthetics. Traditionally, restoring it with your own tissue meant a fat transfer, which requires liposuction to harvest the fat first and enough body fat to harvest in the first place. For thinner patients, or patients who have lost significant weight, that has often been a barrier.
alloClae offers another route. It is donor-derived adipose tissue, processed and terminally sterilized, that arrives ready to use. Because nothing is harvested from your own body, there is no donor site, no liposuction step, and no requirement that you have fat to spare.
How Does alloClae Work?
alloClae is applied beneath the skin in areas where fat naturally exists, providing cushioning, volume, and support. The processing preserves the natural structure of adipose tissue, including the extracellular matrix and the honeycomb architecture that give fat its characteristic feel and behavior. Over the following weeks and months, your own cells and blood vessels populate that structure.
What Should I Expect From My Results?
You should expect results comparable in character to fat grafting. Some of the placed volume integrates and persists, and some is reabsorbed. This is normal and expected, and it is why Dr. Leverett will discuss realistic goals with you, including whether a staged approach makes sense for larger areas.
Is There Downtime?
Recovery is generally straightforward, with most patients returning to light activity within a day or two. Dr. Leverett will give you specific guidance based on the area treated.
Safety and Regulation
alloClae is human tissue, regulated by the FDA as a Human Cell, Tissue, and Cellular and Tissue-Based Product under Section 361 of the Public Health Service Act. This is the same regulatory framework used for many surgical allografts. It is not classified as a drug or a medical device.
Every donor is screened and tested for communicable diseases in accordance with FDA requirements and American Association of Tissue Banks standards. The tissue is terminally sterilized before distribution.
As with any procedure of this type, complications are possible. These may include nodule or cyst formation, pain, infection, bleeding, allergic or immune response, or discoloration of the skin at the treatment site. alloClae is not appropriate for patients with severe allergen sensitivities, a history of anaphylaxis, or an active infection.
Frequently Asked Questions
Is alloClae FDA approved?
alloClae is regulated by the FDA as human tissue, a Human Cell, Tissue, and Cellular and Tissue-Based Product under Section 361 of the Public Health Service Act. It is not classified as a drug or medical device, so “FDA approved” is not the correct description. It is processed under federal tissue banking regulations, and all donors are screened and tested in accordance with FDA and AATB standards.
Where does the tissue come from?
alloClae is derived from screened human donor tissue, processed and terminally sterilized before use.
How is this different from a fat transfer?
A fat transfer uses your own fat, which must be harvested through liposuction. alloClae is ready to use, so there is no harvesting procedure and no donor site. That also makes it an option for patients who do not have enough fat to transfer.
How long do results last?
As with fat grafting, expect partial retention. Some of the placed volume integrates and persists, and some is reabsorbed over the first several months. Dr. Leverett will discuss realistic expectations for your specific treatment area.
