August 7, 2022

Prescriptions: F.D.A. Approves Cell Therapy for Wrinkles

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.

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