Hi Erich,
I donated blood for the development of the assay. I flew from California to Boston on my own dime because I believe in this work. While I was there in mid-March, the Phase 1 clinical trial was beginning. It is a double blind study and of course it is being done with very exacting standards. The Phase 1 recruited volunteers with a maximum age of 45. If you do a little digging a la Google, you will find that many are watching this study like a hawk. It is necessary that the study be done with very carefully .
Complications do not necessarily exclude a person from one of the clinical trials, although the use of some drugs or diseases can--also because of the exacting standards. They may actually choose certain types of complications as a qualifier for later studies. It is the aim of this treatment to cure even long-standing diabetes, rather than just treat the symptoms. The Phase II clinical trial is scheduled to begin in about 18 months.
The current clinical trials are to determine how much and in what order the BCG should be given. It has been known for a long time that one dose of BCG doesn't do the job on diabetes as it does in tuberculosis. There is also a factor in the success of the treatment process regarding blood sugar control during the drug's administration. This is all on the faustmanlab.com website. Also, their newest newsletter has just been released and may be posted on the website also.
The broader aim of this project os to find a way to stop other auto-immune conditions also. If these trials are able to get rid of any of the killer T cells and stop even one auto-immune condition it will be a success, although not the one we are all hoping for. If it eliminates the killer T cells that are destroying our beta cells as they form, even old timers like me may have a chance of re-growing them. It is a good avenue to explore.
Dr Faustman is a very smart,friendly and energetic person. She took time to discuss the study with my husband (who went as my "control" and also gave blood) and me, and make sure all of our questions were answered. Her staff was also friendly and helpful. The study will need more blood donations but because of recent publicity they are getting calls from all around the world. When I was there, appointments were signed up through early 2009.
Don't hesitate to donate blood. They also need non-diabetic control blood for the assays. Donations must be taken at Massachusetts General Hospital in Dr Faustman's lab and cannot be sent by your local lab.
Faustman Lab
Mich
