Dear Listfriends,
Dr. Lieberman has requested the following information be passed on:
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Research Continues for NeuroCellTM-PD Porcine Fetal Neural
Cell For Transplantation for Parkinson’s Disease
Genzyme Corporation and Diacrin, Inc. are continuing clinical research
for NeuroCellTM-PD (porcine fetal neural cells for transplantation) for
the treatment of advanced Parkinson’s disease (PD). The Phase I trial,
in
which twelve patients received implanted cells on one side of the brain,
has followed patients regularly for over two years. Some
improvements were noted at twelve months and efficacy data
continues to be collected. Dr. Samuel Ellias of Boston University
Medical Center presented the two-year clinical results from this trial
at
the Parkinson’s Study Group meeting last October in Seattle, WA.
The study will continue to monitor these patients for a total of five
years to measure the safety of the product and any changes in PD
symptoms.
The enrollment of patients for a Phase II/III trial was
completed last August. Enrollment for an open Phase III trial is planned
to begin during the first half of the Year 2000. Both studies will
evaluate the safety and efficacy of the NeuroCellTM-PD product for
periods of twelve months.
Parkinson’s disease results from a loss of nerve tissue in the
brain. In PD, this nerve damage occurs in areas in the brain that
control
movement and can result in a variety of debilitating motor symptoms,
including tremors, falls, rigidity, slowed movement, and difficulty with
speech.
NeuroCellTM-PD is an injection of fetal pig neural cells
which, when implanted, are intended to replace the function of brain
cells lost in the disease process. NeuroCellTM-PD is being studied to
determine its
effect on reversing or delaying the progression of some of the
disabilities caused by Parkinson’s disease.
For several decades, the drug L-dopa has been used to treat
Parkinson’s patients. By increasing brain levels of dopamine, the brain
chemical deficient in PD patients, treatment with L-dopa can result in
nearly complete control of symptoms in early-stage patients, but it
does not stop progression of the underlying disease. L-dopa begins to
lose its effectiveness after six to twelve years of treatment because of
the continuing loss of nerve cells in the brain. The drug has also been
known to produce serious side effects in some patients.
NeuroCellTM-PD is a surgical therapy that may be useful for those
patients whose symptoms are no longer adequately controlled by
standard anti-parkinson's medications (including L-dopa).
A total of 18 patients have been enrolled in a currently
blinded Phase II/III double-blind trial of NeuroCellTM-PD
transplantation, in which approximately nine patients have received
NeuroCellTM-PD cells and
the rest underwent imitation surgery. Anti-PD medications such as
L-dopa will continue for all of the patients. This trial will evaluate
the
safety and effectiveness of a higher dose of cells, four times the dose
used in the Phase I study, implanted on both sides of the brain.
Patients in this study will be followed for twelve months for any
changes in their PD symptoms and tested regularly for safety during the
study.
Enrollment of patients for an open, Phase III clinical trial
for
NeuroCellTM-PD is planned to begin during the first half the Year
2000. The Phase III study will measure improvements in motor
functions and quality of life after the implantation of NeuroCellTM-PD
cells into patients with advanced Parkinson’s disease and who
continue to receive standard medical therapy, compared with a control
group receiving only standard medical therapy. Patients will be
evaluated for safety and any changes in their PD symptoms during
follow-up visits for twelve months.
The NeuroCellTM-PD treatment carries some risks to the
patient,
including the risks inherent with any minimally invasive brain
surgery. In order to prevent the rejection of the pig cells, transplant
recipients will be required to take cyclosporine, a drug that suppresses
the immune system. The risk of infection with porcine endogenous
retrovirus (PERV) or other infectious agents derived from transplanted
pig cells is unknown. To date, no patients transplanted with
NeuroCellTM-PD
cells have tested positive for PERV or any other pig-derived infectious
agent. These results are consistent with a recent report that evaluated
160 patients worldwide who had been treated up to 12 years
previously with living pig tissue and demonstrated no evidence of
PERV infection. (Science 1999; 285:1236).
Diacrin, Inc. is developing transplantable cells for the
treatment of human diseases that are characterized by cell dysfunction
or cell death and for which current therapies are either inadequate or
nonexistent. Products under development for the treatment of
neurological
disorders include: NeuroCell-FE (porcine fetal neural cells for
transplantation) for focal epilepsy, porcine neural cells for stroke and
intractable pain, and spinal cord cells for spinal cord injury. Also
under
development are hepatocytes for alcoholic hepatitis and cirrhosis,
myoblasts for cardiac disease, and retinal epithelial cells for macular
degeneration.
Genzyme Corporation is a developer of cell therapies and
biological products for the treatment of unmet medical needs. In 1996,
Diacrin and Genzyme Corporation, General Division, formed a joint
venture,
Diacrin/Genzyme LLC, to develop and commercialize NeuroCellä
-PD and NeuroCellä -HD (porcine fetal neural cells for
transplantation) for the treatment of Parkinson’s and
Huntington’s disease, respectively. For more information regarding the
NeuroCellä -PD product, call Diacrin/Genzyme at (800) 285-2556 or visit
the website: www.genzyme.com/neurocell.
--
Kathrynne Holden, MS, RD
Medical nutrition therapy for Parkinson's disease
Author: "Eat well, stay well with Parkinson's disease"
"Parkinson's disease: assessing and managing unique nutrition needs;"
"Risk for malnutrition and bone fracture in Parkinson'sdisease,"
J Nutr Elderly. V18:3;1999.
http://www.nutritionucanlivewith.com/
