Parkinson's DiseasePhase 2NCT00226460
Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients With Parkinson's Disease.
A Phase 2 study testing Fetal porcine cells, Neurocell-PD in people with Parkinson's Disease, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the differences in safety and efficacy between Parkinson's disease patients who either received transplantation of fetal porcine cells or placebo treatment. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Fetal porcine cells, Neurocell-PD
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1997to Jan 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has idiopathic Parkinson's disease. a) with bradykinesia and either rest tremor or rigidity, b) history of asymmetry of Parkinson's disease signs, c) history of progression of Parkinson's disease signs, d) no other suspected cause of Parkinson's disease, e) the patient is L-DOPA responsive (based on the Treating Investigator's clinical judgment, the patient demonstrates a predictable ON response after the first daily dose of L-DOPA)
- The patient has had Parkinson's disease for at least 5 years (from onset of symptoms).
- The patient demonstrates unequivocal Clinical Off periods.
- Patient has been on a stable regimen of L-DOPA and any other anti-Parkinsonian medications for at least one month prior to start of screening.
- The patient demonstrates L-DOPA-or dopamine agonist-induced dyskinesias.
- The patient's age is 40-70.
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- The patient is currently under "optimal medical therapy", as determined by the Treating Investigator.
- The patient has had a UPDRS assessment as per a modified CAPIT protocol at screening and the total UPDRS score in the defined OFF state was at least 60.
- If the patient is a woman of child bearing potential, she must not be nursing and an adequate form of birth control must be used for the duration of this trial.
- The patient has a normal chest x-ray and does not exhibit any signs or symptoms of coronary artery disease (on exam or on EKG) dysrhythmia (in order for surgery to be safely performed).
- The patient is able to understand and is willing to comply with study requirements; this may include travel within or outside the United States for neuroimaging testing and surgery. It will be necessary for a companion to travel with the patient.
- The patient is able to provide written informed consent.
- The patient understands that the Sponsor recommends that all patients in this trial avoid pregnancy and minimize the sharing of secretions with sexual partners.
- The patient is willing to participate in the life-long xenotransplantation registry.
Who cannot join
- The patient has a likely alternative diagnosis for Parkinsonism based on history, physical examination or laboratory testing. Atypical Parkinsonian variants (such as Shy-Drager, olivopontocerebellar atrophy, progressive supranuclear palsy and striatonigral degeneration) and secondary Parkinsonism (e.g., secondary to trauma or metabolic abnormalities; history of encephalitis, oculogyric crises or use of dopaminergic antagonists/depleting drugs) will be excluded.
- The patient has had a prior cranial neurosurgical procedure.
- The patient has MRI or CT evidence of abnormalities which could lead to Parkinsonism or make the patient an unsuitable neurosurgical candidate.
- The patient has a history of intracranial pathology (e.g., tumor, vascular malformation) that might make the patient an unsuitable neurosurgical candidate.
- The patient has a pre-existing medical condition that may interfere with the evaluation of the safety and/or effectiveness of the study agent or prevent study completion (e.g.:, symptomatic cardiac disease, impaired renal function or seizure disorder).
- The patient has a known sensitivity to products of porcine origin (e.g. pork).
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- The patient has a known steroid or cyclosporine intolerance.
- The patient has significant cognitive impairment; specifically, a MMSE score of < 25, and, in the investigators judgment, the patient is demented.
- The patient has a Hamilton Depression score of > 16.
- The patient has hallucinations, delusions, psychosis or chronic psychiatric illness, with the exception of mild, L-DOPA induced hallucinations, or those caused by concomitant medications, which resolve with dose adjustment.
- The patient has a positive response to a tuberculin skin test (with the exception of patients who have either been inoculated for TB, or treated for the disease in the past).
- The patient has been treated during the 6 months prior to Screening with dopaminergic antagonists.
- (Females only) The patient is nursing or pregnant.
- The patient has taken tolcapone within 6 weeks of the Screening UPDRS exam.
Trial locations and contacts
1 site in 1 country.
United States1 site
PD and Movement Disorders, University of South Florida
Tampa, Florida, 33606
About this study
The purpose of this study was to evaluate the differences in safety and efficacy between Parkinson's disease patients who either received transplantation of fetal porcine cells or placebo treatment.
- Conditions
- Parkinson's Disease
- Being tested
- Fetal porcine cells, Neurocell-PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal porcine cells, Neurocell-PDDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in UPDRS
Secondary outcomes (1)
change in PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startAug 1997
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Diacrin/Genzyme Corporation LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226460
- Sponsor's protocol ID
- PD96-1101
- Status last verified
- Mar 2015
- First submitted
- 23 Sep 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00226460
- Acronym / sponsor ID
- PD96-1101
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Diacrin/Genzyme Corporation LLC
- Study start
- Aug 1997
- Study completion
- Jan 2001
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the differences in safety and efficacy between Parkinson's disease patients who either received transplantation of fetal porcine cells or placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient has idiopathic Parkinson's disease. a) with bradykinesia and either rest tremor or rigidity, b) history of asymmetry of Parkinson's disease signs, c) history of progression of Parkinson's disease signs, d) no other suspected cause of Parkinson's disease, e) the patient is L-DOPA responsive (based on the Treating Investigator's clinical judgment, the patient demonstrates a predictable ON response after the first daily dose of L-DOPA)
- The patient has had Parkinson's disease for at least 5 years (from onset of symptoms).
- The patient demonstrates unequivocal Clinical Off periods.
- Patient has been on a stable regimen of L-DOPA and any other anti-Parkinsonian medications for at least one month prior to start of screening.
- The patient demonstrates L-DOPA-or dopamine agonist-induced dyskinesias.
Key exclusion criteria (14 listed)
- The patient has a likely alternative diagnosis for Parkinsonism based on history, physical examination or laboratory testing. Atypical Parkinsonian variants (such as Shy-Drager, olivopontocerebellar atrophy, progressive supranuclear palsy and striatonigral degeneration) and secondary Parkinsonism (e.g., secondary to trauma or metabolic abnormalities; history of encephalitis, oculogyric crises or use of dopaminergic antagonists/depleting drugs) will be excluded.
- The patient has had a prior cranial neurosurgical procedure.
- The patient has MRI or CT evidence of abnormalities which could lead to Parkinsonism or make the patient an unsuitable neurosurgical candidate.
- The patient has a history of intracranial pathology (e.g., tumor, vascular malformation) that might make the patient an unsuitable neurosurgical candidate.
- The patient has a pre-existing medical condition that may interfere with the evaluation of the safety and/or effectiveness of the study agent or prevent study completion (e.g.:, symptomatic cardiac disease, impaired renal function or seizure disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal porcine cells, Neurocell-PD | Drug | – |
Primary outcome
change in UPDRS
1 secondary outcome
change in PET scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fetal porcine cells, Neurocell-PD in people with Parkinson's Disease, run by Genzyme, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in UPDRS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.