gum recession treatment

[danya]

isolagen may be useful to treat gum recession...

Isolagen Shows Positive Results in the Dental Study
Wednesday December 3, 9:01 am ET


HOUSTON, Dec. 3 /PRNewswire-FirstCall/ -- Isolagen, Inc. (Amex: ILE - News), a biopharmaceutical company specializing in the development and commercialization of autologous cellular therapy for hard and soft tissue regeneration, is pleased to announce that it has received preliminary positive results from the Isolagen Dental Study conducted at the University of Texas Health Science Center Dental Branch ("UTHSC").

The Isolagen Dental Study is being conducted at UTHSC with 21 patients. Dr. Otis Bouwsma, associate professor at UTHSC, was the principal investigator in Isolagen's Dental clinical study. Dr. Otis Bouwsma stated, "On a preliminary review of the data of the triple blind study, it is clear the patients we assume received Isolagen have had significant improvements in the two areas of treatment: the deep pocket areas and in the gingival recession areas. A benefit of up to 4 mm was seen is some of the deep pocket areas. This autologous cellular treatment may potentially play a huge role in the way gum recession is treated in the future. The blind on this study will be lifted at the end of December 2003 so a full quantitative data analysis and report will be available in the first quarter of 2004. With what I have seen from a clinical perspective from administrating the procedures chair-side, I am highly encouraged by these preliminary results."

Mike Macaluso, CEO of Isolagen, stated, "Though the UTHSC observations are preliminary, we are very encouraged by these observations and we plan to move forward to start the design of what we hope will be our final Phase III dental study to the United States Food and Drug Administration ("FDA")."

About Isolagen, Inc.

Isolagen, Inc. is the parent company of Isolagen Technologies, Inc., which was founded in 1995. Isolagen has focused its efforts in the development of autologous cellular technology that has specific applications in cosmetic dermatology and is exploring applications for periodontal disease, reconstructive dentistry and other health-related markets.

[Marilyn]

What is the present status of isolagen? Is it yet available in USA or elsewhere in world? Is it being used to re-build dental bone? Is it possible to be included in their research trials? If so, how would one access this project?

[danya]

this is from the isolagen website:

Clinical Trials

Dental
Isolagen is engaged in a Phase I exploratory trial to illustrate the therapeutic uses of autologous fibroblasts for various types of gingival disease (gum disease). Modern dentistry has been successful in conserving and straightening teeth, but has fewer options available for the treatment of gum disease. Good dental hygiene and modern periodontal practices have been successful in preventing and palliating the progression of gingivitis to a certain degree. Based on anecdotal observation using Isolagen for the treatment of gum disease, the present trial was designed to objectively establish the therapeutic effect of Isolagen on gum recession associated with excessive brushing, dental papillae loss and increasing pocket depth. The study involved the evaluation of the height of the gum and depth of the pocket in matched treatment areas. The areas for treatment are randomly assigned to the placebo or treatment group. Since each patient may have multiple sites treated, each patient acts as their own control. Twenty-one patients are enrolled in the dental study. Data collected includes pocket depth measurements, photograph assessments and radiology evaluations. The primary end point of the study is at six months with all patients monitored for twelve months. Analysis of the monitored data will occur during the first quarter of 2004.
Phase II Dermal
As part of the regulatory path to the biological license agreement, Isolagen conducted a Phase II dose ranging trial on forty patients using a placebo and three dose concentrations. Previous experience with the use of Isolagen from the years of 1995-1999 and present day commercial application in the United Kingdom and Australia demonstrated the efficacy of the existing dose regiment. The trial had multiple goals which included the standardization of the injection technique, evaluation of a photo guide assessment, design of case report forms, logistics of cell production, patient evaluation and cell transport. The primary end point was four months with all patients being monitored for twelve months. At the end of the four months, patients who received a placebo or the lowest therapeutic dose (believed to be sub-therapeutic) were offered treatment with the full therapeutic dose. These patients are to be followed for an additional twelve months. Results to date have identified the need for extending the photo training procedure which highlights the differences between the Isolagen therapy and other filler materials.

Phase III Dermal
This is a double blinded placebo controlled trial to determine the therapeutic dose. The trial is being conducted at multiple centers with ten sites across the continental United States. The trial is divided between dermatologists and plastic surgeons with the assessment of eight types of facial lesions. The primary end point is at four months with a cross over of patients. All patients are monitored for twelve months after receiving the initial injection. One hundred fifty-two patients were enrolled in the trial. Data collection is in progress and the acute phase is finished with analysis of the primary end point expected in February or March.

Isolagen is planning further dental studies, in addition to studies involving the assessment of vocal cord lesion therapy and wound treatment.