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This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.
All subjects who received BRT-DA01 transplantation in Study MSK-DA01-101 (ie, parent study) will be asked to enroll in Study BRT-DA01-501. Subjects enrolled in this study are to be monitored for safety and clinical outcomes through 5 years post-BRT-DA01 transplantation. For individual participating subjects, the Baseline visit for the BRT-DA01-501 study will be defined as the last observation recorded in the parent study.
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| Measure | Description | Time Frame |
|---|---|---|
| Total SAEs and total number of subjects with at least 1 SAE | Total SAEs and total number of subjects with at least 1 SAE related to cellular drug product | Baseline through 5 years post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in striatal 18F-DOPA uptake using positron emission tomography (PET) | Change in striatal 18F-DOPA uptake using positron emission tomography (PET) | Baseline through 5 years post-transplantation |
| Change in Hauser PD diary measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | AEs related to the cellular drug product | Baseline through 5 years post-transplantation |
| Change in modified Schwab and England Activities of Daily Living (mSEADL) scale | Change in mSEADL |
Inclusion Criteria:
Exclusion Criteria:
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Advanced Parkinson's Disease who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101
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| Name | Affiliation | Role |
|---|---|---|
| Nauman Abid, MD | BlueRock Therapeutics LP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Orange | California | 92868 | United States | ||
| Weill Cornell Medical College |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Biomarkers for PD may be explored
Change in Hauser PD diary measurements
| Baseline through 5 years post-transplantation |
| Change in the International Parkinson and Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS) | Change in the MDS-UPDRS | Baseline through 5 years post-transplantation |
| Change in levodopa equivalent daily dose (LEDD) | Change in LEDD | Baseline through 5 years post-transplantation |
| Change in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index | Change in PDQ-39 | Baseline through 5 years post-transplantation |
| Change in the Unified Dyskinesia Rating Scale (UDysRS) | Change in UDysRS | Baseline through 5 years post-transplantation |
| Baseline through 5 years post-transplantation |
| Change in brain atrophy using MRI | Change in brain atrophy using MRI | Baseline through 5 years post-transplantation |
| Subjects using alternative advanced treatment options in Parkin's Disease | Number of subjects using alternative advanced treatment options in PD (eg, CSAI, LCIG, DBS, focused ultrasound ablation) | Baseline through 5 years post-transplantation |
| New York |
| New York |
| 10065 |
| United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |