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Hello all -

A major teaching hospital in Boston (In my humble opinion the medical center
of the world) is seeking applicants to participate in a new cellular surgical
therapy trial for Parkinson's.  This project is similar to the so-called "pig
cell" study.

It is known as the STEPS Trial.  This study is designed to test the safety
and efficacy of a cell therapy called Spheramine.  Like the embryonic pig cell
transplantation experiment, cells that make dopamine are surgically implanted
into a PD patient's brain in the area called the putamen.  The cells used in
the Spheramine trial are obtained from the eyes of human cadavers and are called
Retinal Pigment epithelial cells (RPE Cells).  The cells are first processed
so that they are on the surface of microscopic gelatin spheres.  They are not
stem cells, are not cells from embryos and are not from animals.

Spheramine has already been tested in monkeys and the cells produced dopamine
after being transplanted.

Spheramine has already been tested in 6 PD patients in an open label trial.
In this initial safety trial all patients received transplantation of
Spheramine into 1 side of the brain.  And all were improved in 3 to 9 months.  This
study was reported by Dr. Ray Watts at the American Academy of Neurology this
past year.  None of the patients had any side effects and none were treated with
immuno-supression drugs.

Since the first trial demonstrated safety, a second trial (the STEPS trial)
has been started to test the efficacy of Spheramine.  This trial is a larger,
double-blind, multi-center study.  In this particular study participants will
either receive transplantation of Spheramine into both sides of the brain OR
undergo "sham" (mock) surgery.  If this technique proves to be safe and
effective, the patients in the mock group will be given the opportunity to receive the
"real" therapy.

Some of the requirements include the following:

Patients must be between 30 and 70 years old.

They must have had PD for a minimum of 5 years.

Also, they must exhibit a response, either good or bad, to Parkinson's
medications.

The patient and their caregiver must be willing and able to travel to have
the surgery performed and must be able to undergo MRI scanning.

Additionally, the patient must NOT have had any prior brain surgery, strokes,
seizures, or severe depression or dementia.

Recruiting of patients is going on now.  If you are aware of any patients who
would be interested in participating in this study they can contact Cathi
Thomas at Boston University Medical Center - Neurology - Tel (617) 638-7737.
Feel free to mention my name.

If I can answer any questions you might have please E-mail me directly.

Warmly -

Jim Finn

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