Use of Isolagen, Cultured Autologenous Fibroblasts for Wrinkle Reduction.

Authors: Mentz H, Ruiz A, Patronella C, Newall G, Mentz G., Clift V.

The first plastic surgeon to present data on Isolagen (the use of a patient’s own fibroblast cells for wrinkle reduction and acne scar improvement. Dr. Mentz was the only US plastic surgeon to host the phase 2 and 3 FDA studies for design and safety), presented at America’s most prestigious plastic surgery society.

Mentz H, Ruiz A, Patronella C, Newall G, Isolagen, Cultured Autologenous Fibroblasts for Wrinkle Reduction. Podium presentation.

Annual Meeting, American Society of Plastic Surgeons, Philadelphia, Pennsylvania October 12, 2004.

Abstract

Autologous cellular therapy is a process whereby a patient’s own cells are extracted, reproduced and then reintroduced to the patient for specific cosmetic and medical applications.

Present the preliminary results of the clinical Phase III FDA protocol undertaken with Isolagen Technologies, Inc. with the use of cultured autologous fibroblasts for the correction of facial rhytids and facial scars.

The study was conducted at ten (10) sites in the United States. 154 patients enrolled for treatment and a total of 146 patients were evaluated. Of the 154 patients, 107 were treated for facial rhytids (27 received placebo) and 47 were treated for facial scars like acne and traumatic scars (14 received placebo). These patients were 90.5% female and 9.5% male and were a mean age of 46.8 years old. 91.5% were Caucasian, 4.4% Asian, 1.9% Hispanic, and 1.9% Black. The three (3) mm postauricular biopsies were sent to the manufacturer’s lab and fibroblasts were extracted and grown over a six week period. A 1.2 cc vial of fibroblasts was sent in culture broth (20 million cells/ml) to the treating physician for injection into the dermal defect at three intervals over 3 to 6 weeks. Placebo injections were administered in this random double blind study in 25% of cases.

Assessments were planned at 1, 2, 4, 6, 9 and 12 months by physician and patient evaluation on a 7 level photo scale for each area and a visual analog scale.

We present the data for 1, 2, 4 and 6 months. The results for 9 and 12 months are pending. Patients who improved 2 or more levels on the 7 level photo scale were considered responders. The average placebo response was subtracted from responders in order to underscore the response results. The injected fibroblasts improved facial rhytids and scars, and the results improved with time. At 1 month 57% responded more than 2 levels, at 2 months 79.6%, at 4 months 77.1% and at 6 months 81.6% (Fisher Exact Test <.0001 at 2, 4, and 6 months). There were no serious adverse effects. Other events that did occur included bruising and /or swelling at the injected site.

We feel very optimistic with the initial results. Cultured fibroblast therapy appears to be both safe and effective. The 9 and 12 month evaluations will be completed shortly and we hope to be able to recommend this modality for soft tissue regeneration. Additional research is being conducted to further investigate this modality. The application of this therapy to other soft tissue defects including periodontal disease, stretch marks, and nerve trauma is also being studied.

Slide Presentation (outline)

Use of Cultured Fibroblasts for Facial Rejuvenation

American Society of Plastic Surgeons

Mentz H, Ruiz A, Patronella C, Newall G, Mentz G., Clift V.