美國 FDA 核准 第一項 自體細胞 填充物

FDA Okays First Autologous Filler for Smile Lines

下圖是什麼??  azficel-T

(本照片取自medscape news 網站)

別看這東西不起眼 這可是高科技 由人的耳後取得的fibroblast (纖維母細胞) 經過 培養

(本照片取自medscape news 網站)

法令文 一共三次治療 間隔 3 to 6 週  改善的效果如圖示

"The concept of using a patient's own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance,"

"Since this is a biological process that works over time, [azficel-T] is able to provide gradual and natural-looking results,"

This approach is "likely appeal to patients who want to take a very new approach to treating wrinkles"

"By injecting tens of millions of the person's own fibroblasts, patients now have the option to help smooth smile lines by adding cells to replace those that may have been lost through the aging process

以上說明了 這是一個很新的 完全個人客制化的 漸進 自然的 改善方法

當然也不是沒有缺點

1. "it's going to depend on whether the results are better than with off-the-shelf injectables, such as Juvederm (Allergan), Restylane (HA North American Sales AB), and Sculptra (Sanofi-Aventis), which are the main competition."
2. a limiting factor is that the patients have to have a biopsy and then wait 3 months before they get their injections, and then they have to go through a series of treatments. It's a long process. Physician acceptability, with the length of time involved, may also be an issue

簡單的說 要和现有的填充物 競爭 效果 而且治療周期長的多 想必費用也很驚人

不管如何 這是一個劃時代的產品 表示 醫學美容的項目 已經從穿制服 進階到 每個人量身訂做的階段 這樣的改變 不單只是在法令紋 很快的也會延伸到抗老化 脂肪再生 等等 : 周爾康 醫師 見解