| ID | Type | Description | Link |
|---|---|---|---|
| 305405 | Other Identifier | Company Internal |
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Study was completed, only life long extended follow-up phase was discontinued after 12 years.
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| Name | Class |
|---|---|
| Titan Pharmaceuticals | INDUSTRY |
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The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spheramine (BAY86-5280) | Biological | Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery | 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total UPDRS in ON and OFF at 12 months post surgery | 12 months post surgery | |
| Change in UPDRS Part III in ON at 12 months post surgery | 12 months post surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21565557 | Derived | Gross RE, Watts RL, Hauser RA, Bakay RA, Reichmann H, von Kummer R, Ondo WG, Reissig E, Eisner W, Steiner-Schulze H, Siedentop H, Fichte K, Hong W, Cornfeldt M, Beebe K, Sandbrink R; Spheramine Investigational Group. Intrastriatal transplantation of microcarrier-bound human retinal pigment epithelial cells versus sham surgery in patients with advanced Parkinson's disease: a double-blind, randomised, controlled trial. Lancet Neurol. 2011 Jun;10(6):509-19. doi: 10.1016/S1474-4422(11)70097-7. Epub 2011 May 10. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Procedure | Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain. |
|
| Amount of L-dopa reduction at 12 months post surgery |
| 12 months post surgery |
| Activities of Daily Living subscore of the UPDRS at 12 months post surgery | 12 months post surgery |
| Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery | 12 months post surgery |
| Percent time spent in ON and OFF at 12 months post surgery | 12 months post surgery |
| Los Angeles |
| California |
| 90095 |
| United States |
| Tampa | Florida | 33606 | United States |
| Atlanta | Georgia | 30329 | United States |
| Chicago | Illinois | 60612 | United States |
| Kansas City | Kansas | 66160 | United States |
| Boston | Massachusetts | 02118 | United States |
| New York | New York | 10029-6574 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Houston | Texas | 77030 | United States |
| Marburg | Hesse | 35039 | Germany |
| Homburg | Saarland | 66424 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Hamburg | 22307 | Germany |
| Barcelona | 08036 | Spain |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |