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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.
Subjects will undergo surgical transplantation of the dopamine-producing cells under general anesthesia into a part of the brain called the putamen. Subjects then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. Safety, tolerability, evidence of cell survival (using MRI and PET scans of the brain), and effect on Parkinson's disease symptoms are assessed for 2 years post-transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSK-DA01 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSK-DA01 | Biological | MSK-DA01 is an experimental product derived from human embryonic stem cells. The stem cells were converted into brain cells that produce dopamine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The incidence of Serious Adverse Events (SAEs) at 1 year post-transplant. or abnormal tissue overgrowth related to presence of transplanted cells; | Baseline to 1 Year Post-Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Cell Survival | Change in 18F-DOPA uptake using positron emission tomography (PET) from baseline to 1 and 2 years | Baseline to 1 Year Post-Transplant and Baseline to 2 Years Post-Transplant |
| Changes in Motor Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| Weill Cornell Medical College |
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| MSK-DA01 Cell Delivery Device | Device | A device that is used for injection of fluids into the brain will be used. Some minor modifications have been made to the device to allow delivery of MSK-DA01 cells. |
|
Changes in MDS-Unified Parkinson's Disease Rating Scale (UPDRS) motor sub-score in the "off" state from baseline to 2 years post-transplant.
| Baseline to 1 Year Post-Transplant and Baseline to 2 Years Post-Transplant |
| Changes in Waking Hours in "Off" State | Changes in number of waking hours in the "off" state from baseline to 2 years post-transplant. | Baseline to 1 Year Post-Transplant and Baseline to 2 Years Post-Transplant |
| Continued Safety and Tolerability | Incidence of SAEs at 2 years post-transplant and incidence and type of AEs at 1 and 2 years post-transplant. | Baseline to 1 Year Post-Transplant and Baseline to 2 Years Post-Transplant |
| New York |
| New York |
| 10065 |
| United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |