Originally Posted by jilanguille (Post 138660)

My mother was one of the phase IIb study participants. At the time of enrollment, she was scoring 89-90% on the activities of daily living scale while medicated. Within months after Spheramine she went into a nursing home unable to walk, bath, dress, toilet or feed herself. She was one of 2 patients enrolled through UCLA. The other patient died.

She suffers from hallucinations and has to be restrained because of them.
My mother has spent almost 2 years in a nursing home, in the dementia ward, in restraints due to spheramine and yet is aware of her situation. I wouldn't wish that experience on any living soul.

The records attribute her decline and hallucinations as certainly due to the procedure and probably due to the spheramine.

The informed consent states if you are injured care will be provided at no cost to you. This is not the case. To date none of the cost of care has been paid.

Originally Posted by BobT (Post 130093)

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.