FDA批准细胞治疗皱纹
2011-06-23 02:39:00   来源：   

June 22, 2011, 3:08 pm

FDA Approves Cell Therapy for Wrinkles
By ANDREW POLLACK

Blood stem cells, as from a bone marrow transplant, are used to treat serious cancers. Therapies using other types of stem cells, mostly still experimental, are envisioned to help repair damaged organs and to treat scourges like diabetes and Parkinson’s disease.
But cell therapy can also have its more trivial applications, like smoothing wrinkles. The Food and Drug Administration late Tuesday approved a therapy that uses a person’s own skin cells to help improve the appearance of the smile lines that can extend from the bottom of the nose to the sides of the mouth.
The treatment, called laViv, was developed by Fibrocell Science of Exton, Pa. It involves taking a sample of skin cells called fibroblasts, which make collagen, from behind the person’s ear. The sample is sent to the company’s laboratory, where the fibroblasts are multiplied in cell culture, a process that takes 11 to 22 weeks.
The cells are then sent back to the doctor, who injects them into the smile lines, (or frown lines), which are technically known as nasolabial folds.
The treatment was evaluated in two clinical trials with a total of 421 patients in which participants received either three treatments with laViv or three treatments with an injection that did not contain the cells. Six months after the third treatment, both the patients and their doctors, neither of whom knew whether the treatment or control was given, assessed the results.
In one study, 57 percent of the patients who got laViv thought the appearance of their own wrinkles had significantly improved, while only 30 percent of those in the control group thought so, according to the drug’s label. In the other study, 45 percent of those who got the treatment and 18 percent of those who got the control thought the appearance had improved.
Their doctors were a bit more critical. They thought the wrinkles’ appearance improved significantly in only 33 percent of the patients who received LaViv in one study and 19 percent in the other. But those figures were still higher than the 7 percent improvement in both studies for the control group.
The most common side effect, occurring in two-thirds of patients, were injection site reactions including redness, bruising, swelling, pain and hemorrhage.
LaViv will compete with various dermal fillers. Fibrocell has not announced a price, but a spokeswoman said it was expected to be $1,000 to $2,000 to create the personalized cell bank, and then perhaps $300 to $500 for each of the three treatment sessions.
Lack of funding has hindered development of the treatment. The company pursuing it, once known as Isolagen, filed for bankruptcy protection in 2009, but emerged a few months later as FibroCell.
Fibrocell’s shares, traded on the OTC Bulletin Board, were up 11 cents to $1.27 at 1:54 p.m.
US approves cell therapy injection for wrinkles
(AFP) – 4 hours ago
WASHINGTON — US regulators have approved a new type of therapy that uses a person's own skin cells to create an injectable cosmetic plumper to smooth out laugh lines, Fibrocell Science said Wednesday.
The Food and Drug Administration approved late Tuesday the Pennsylvania-based company's application for license to market laViv, which uses a person's own collagen cells, multiplies them, and creates an injectable substance.
"LaViv is the first and only personalized aesthetic cell therapy approved by the FDA for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults," a company statement said.
"In clinical trials, laViv was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within one week."
The company has a patent on a process of extracting and multiplying a person's skin cells known as fibroblasts, which are responsible for making collagen, the protein that keeps skin firm and resilient.
Fibrocell said the FDA approval came after two phase III randomized, double blind trials of 421 patients who received either laViv or a placebo in three three treatments about five weeks apart.
Those trials showed laViv "effectively improved the appearance of nasolabial fold wrinkles," the company said.
In one study, 57 percent of patients on laViv saw an improvement compared to 30 percent who received the placebo treatment, according to a summary of the research published by the New York Times.
In the other, 45 percent of patients receiving laViv thought they looked better afterward, compared to 18 percent in the control group.
Doctors' opinions were more reserved -- 33 percent in the first trial and 19 percent in the second trial said they saw an improvement in their patients from laViv, the report said.
The most common side effects were redness, pain, swelling or bruising at the injection site, the company said.
Further studies are necessary to see how long the treatment lasts. The follow-up studies to date have only spanned six months.
Doctors take a sample of cells from behind a patient's ear and send those cells to a lab where scientists replicate hundreds of millions of fibroblasts and freeze them until they are needed for treatment, a process that takes about 90 days.
"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," said Robert A. Weiss, a clinical professor at Johns Hopkins School of Medicine one of the investigators on the trials.
"Since this is a biological process that works over time, laViv is able to provide gradual and natural-looking results."
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