I have seen a number of reports re. implanting RPE cells (retinal pigment epithelial cells). The one below is being researched at the university of Arizona:

http://www.wistv.com/Global/story.asp?S=6844641

and allegedly a stem cell based option is all but here:

http://news.bbc.co.uk/1/hi/health/6721685.stm

Does anyone know how this relates to Spheramine (RPE cell transplant) and are the parties concerned talking ?

Neil.

Neil,

I live in Arizona and have met Dr. Brian McKay. He is an eye specialist/researcher at the University of Arizona.

A few weeks ago he gave a presentation at the U of A about implanting retinal cells in pwp. (I'll find that link and post it) From his presentation, it sounded like he is also a consultant for Spheramine (Titan / Bayer) because he talked about his association with ongoing trials using retinal cells.

Here is the link to his talk:

http://streaming.biocom.arizona.edu/event/?id=20780


Also I spoke to him a few months ago at a MJ Fox Science Roundtable here in Arizona and he proposes to do something slightly different from Spheramine - he would still use retinal cells, but autologous - use the patient's own retinal cells so there will be no risk of rejection.

A local PD association tried desperately to get funding for his research this year. But unfortunately the timing for getting an application submitted and through the approval process was bad, so to our great disappointment, he did not get funding this year.

He is still testing on animals. But I'm following this closely. Whenever / If ever there is a phase I trial - I would be interested in it - and glad to find such promising research so close to my home.

where else could you get such informed info so quickly.

Neil.

Neil

As you know I saw my neurologist recently and he said that there were currently around 150 PD cell and gene research projects ongoing worldwide with spheramine & Cere120 being two of the more high profile because they are at an advanced clinical trials stage.

Chris

Avoid spheramine. It can cause inflamation, increased imbalance and severe hallucinations and lead to immediate and permanent nursing home residence; wheelchair, diaper, restraints.

Please explalin further or give a url where the information can be found if it is not too personal.

Thanks thelma

Our friend Peggy Willocks swears by hers, she was one of the original recipients. Is this one person we are talking about??

If it is, it sounds like this poor soul had a stroke , or possibly an allergic reaction(?) during or immediately after their surgery.

I would not pass judgement on spheramine based on one person's experience. Be it good or bad.

Charlie

only one of the original six has had major problems (results on Phase II are not in), and that one was diagnosed with MSA (Parkinson's Plus).

Where did you hear this? It is possible - we were told about one brain bleed with the surgery, but he totally recovered from it.

And although I'm now having problems from my one untreated side, i've had iss pretty good for seven years. but as Charlie says, you can''t assess a treatmet based on one report.

please - be open - no names - just facts, please

Peggy

i am a spheramine patient. While results are not complete periodic updates are sent to FDA. At the time of my surgery the results of 55 had been reported with 13 still in process. According to my documents dated August 2006, the first surgery was April 2003, the last June 2007.
Attached is results of 55 in phase 2 directly from my consent form
What follows is only 2 of 17 pages related to spheramine. whie you may see severe reactions by a few, procedure changes resulted. As in anything some will only see the negatives, others a future. there are no edits.........................
A total of 10 sobjects experienced serious side affects possibly related to the study treatment (surgery or spheramine)
Two subjects died. On subject died from cancer of the esophagas, which was considered entirly unrelated to sphermine treatment. The subject also had bleeding in the brain with temporary weakness of one body side, speech problems and seizures, which was thought to be related to study surgery.. Before he died from cancer he had recovered from symptoms of bleeding from the brain. One subject had a fall, broke a rib and acquired pulmonary infection and empyema and died. This subject also had transient confusion after surgery for one day. He then improved and then had markedly better UPDRS scores (by 23%), but later experienced mental and physical deterioration. Brain autoposy from this subject is available, it demonstrated vital hRPE cells on microcarriers in the brain.

One more subject had bleeding in the brain with temporary weakness of one body side, speech problems, and seizure. He also had a low blood pressure (hypotension) and required artificial respiration. These symptoms have meanwhile resolved, but required prolonged rehabilitation. After surgery and changes in the medication, another subject had dyskinesia (violent involentary movement) and difficulty breathing (asthma attack) taht required artificial respiration for a short period. This subject also had minor bleeding on the brain surface which was not thought to cause any symptoms. Two weeks later, this subject had a dilusional episode (period of confusion) accompanied by suicidal thoughts. these events resolved after adjustment of the subject's antiparkinsonian medication.

Another subject had transient (1day) weakness of one arm and an epileptic seizure resulting from the temporary occlusion of a brain vein. The subject recovered completely after one week.

One subject had experienced brief periods of confusion (lasting up to 5 days), which prelonged her post-surgical hospital stay. The confusion occured at the same time as thinking disorders and dystonia. She had additional temporary weakness lasting up to 7 days. She recovered from these symptoms and improved in her PD symptoms, however later in that course of the trial, the neurological status of this subject worsened including mental deterioration. She is living in a nursing home and needs a wheelchair and feeding by a tube going through her nose to the stomach. The causal relationship of this deterioration with Spheramine treatment is unclear.

One subject experienced worsening of dyskinesia one day after study surgery, which prolonged the post-surgical hospital stay. The symptoms resolved.

One subject experienced paranoid delusions and agitation during the night after surgery. Several weeks later, this subject developed depression. His symptoms are completely resolved.

Two subjects required a hospital stay due to paranoid thoughts and delusion that occured several months after surgery, one 14 months and one 5 months after study treatment. It is uncertain if these problems were related to study drug or would also have occured in the natural course of their disease. One of these two subjects was recovered after 3 weeks, one is recovering.

Another subject experienced neck pain since surgery. It was found that he had a broken neck vertebra, however it was unclear if this was related to surgery since he was known to have had neck surgery in 1995, and the fracture was not fresh when it was detected 6 months after surgery.

Based on the findings of an Independent Data Monitoring Committee (IDMC) comprised of internationally recognized Parkinson's Disease experts, the severity and frequency of these serious side effects are in line with the complications that could normally be expected after this type of intervention. In particular, it is not to be expected that such events will occur in association with sham "placebo" operations. Following recommendation of the Chairman of the IDMC, a number of additonal safety measures have been implemented in the study protocol.

In addition, the following non-serious events seen in study subjects were considered to be possibly, probably, or definitely related to surgery and/or to study drug (Spheramine or Placebo). Common events that occured in 5 or more (or >10%) of 52 subjects were: nausea, violent involuntary movement, altered muscle tone, hallucination and headache. The common AEs occuring in 3 or more (or >5%) of subjects were: slow heart beat, weakness, pain, impaired healing, blood pressure increased, balance disorder, disturbance in attention, slow reflexes, confusional state, depression, insomnia, high blood pressure and low blood pressure.

for that. No one said it was going to be easy.

GO HARD........... SCIENCE