if you can find an email or phone number - call them...

Good thing you did ask lfac. Gill didn't use his own pump, he was forced to use a medtronic. In spite of all my time spent on this subject, I don't think I ever realized that Gill never got to use his pump. It wasn't used in Bristol because Amgen was leary for already trying GDNF with injection and had already halted it once before in the 90's. Amgen wouldn't use Gill's for phase II either because it wasn't FDA approved. Here's a link to the GDNF summary on pipeline - clinical trials section includes the different delivery systems.

http://pdpipeline.org/advocacy/gdnf_...ew.htm#monkeys

Monkeys in the Middle [ch 11 and 15] explains the difference in the pumps designed by Gill and another designed at the University of Kentucky. To attempt to put it simply, Gill and the un of K scientists felt that the pump should have some pressure behind it [convection enhanced] to shoot it into the putamen. The pumps they were required to use did not "push" it out and they worried that it would congregate around or reflux back up into the catheter - one explanation for why it worked for some and not others.

Amgen chose a different pump/catheter for phase II, causing one prominent researcher to quit. It was larger, more invasive.

paula

Hi paula,
I checked one of the articles Gill and his colleagues wrote about the phase I study and he did use a Medtronic pump, but he designed the catheter.

" Intraputamenal Infusion of Glial Cell Line–Derived Neurotrophic Factor in PD:

A Two-Year Outcome Study"

Nikunj K. Patel, FRCS,1 Martin Bunnage, MPsych,1

Puneet Plaha, FRCS,1 Clive N. Svendsen, PhD,2

Peter Heywood, FRCP,1 and Steven S. Gill, FRCS1

In Ann Neurol 2005;57:298–302

"Patients and Methods

Five patients with idiopathic PD underwent stereotactic implantation of intraparenchymal catheters (in-house investigational device) into the posterodorsal putamen, which then were connected to SynchroMed pumps (Medtronic, Minneapolis, MN) implanted in the abdominal wall as described."

You're right on about the phase II trial -- Amgen chose to use a different, larger catheter for phase II, causing one prominent researcher to quit.

Also the dosage and method of delivery was different between the phase I and II trials.
This was summarized in "Crossroads in GDNF Therapy for Parkinson’s Disease" (Todd Sherer et al) in Movement Disorders, Vol. 21, No. 2, 2006, pp. 136–141 and discussed further in subsequent artciles by Bristol and Un. of Kentucky researchers, and others. Further research was recommended.

See: http://www.pdpipeline.org/advocacy/g...ch_history.htm

From the Movement Disorders article - Comparison of studies:
Dosage:
Bristol: Not standardized; different patients were dosed differently; range from 14.4 to
42.4
g/day and back
Kenrucky: 3
g/day for 2 months, 10
g/day for 2 months, 30
g/day for 2
months; 1-month washout
Amgen :15
g/putamen/day

Delivery
Bristol: Catheter may have provided convection enhanced delivery, but was not FDA approved

Kentucky: Medtronic multiport catheter; idle phase of delivery followed by
pulses every 6 hours

Amgen: Single-port Medtronic catheter (larger than Bristol catheter)

Thanks Linda! I didn't think about them being separate and was wondering about why I could have sworn Gill used his own.

Neil, I'm throwing your question back to you. Was something said at a meeting recently about Gill and Amgen? I know he was definitely trying to use their GDNF again but it's been awhile.

paula