Isolagen (http://www.isolagen.com) is a company that extracts a tiny sample of gum tissue from behind the wisdom teeth, expands the sample in a lab over a 6 week period, and then injects these naturally produced autologous (patient's own) gum cells back into the patient.
This process is currently in Phase 2 trials. There are 2 separate P2 trials going on - one for deep pocket disease and the other for papilla regeneration. Papillas are the triangle shaped gum tissues between the teeth - if they are missing or blunted, an ugly "black hole" appears.
Here are some of the recent press releases regarding the progress of clinical trials:
Isolagen Completes Phase I Dental Study And Begins Phase II Dental Study
http://www.isolagen....20PR-Dental.pdf
Isolagen Announces Additional Support for Results in Phase I Dental Study
http://www.isolagen......20- FINAL.pdf
Isolagen Announces Positive Results in Phase I Dental Study
http://www.isolagen......20- FINAL.pdf
Here is an exert from their website regarding the initial phase 1 trial:
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.
I'm guessing that the Phase 3 trial will begin sometime in the spring of 2005.
- Bryan Hall
bryan8266@earthlink.net
