Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 50 years — 78 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01, a Human Embryonic Stem Cell-Derived Midbrain Dopaminergic Neuronal Cell Therapy
Overview
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.
Detailed description
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.
Primary outcome measures
- Total SAEs and total number of subjects with at least 1 SAE [Time frame: Baseline through 5 years post-transplantation]
Secondary outcome measures (6)
- Change in striatal 18F-DOPA uptake using positron emission tomography (PET) [Time frame: Baseline through 5 years post-transplantation]
- Change in Hauser PD diary measurements [Time frame: Baseline through 5 years post-transplantation]
- Change in the International Parkinson and Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS) [Time frame: Baseline through 5 years post-transplantation]
- Change in levodopa equivalent daily dose (LEDD) [Time frame: Baseline through 5 years post-transplantation]
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index [Time frame: Baseline through 5 years post-transplantation]
- Change in the Unified Dyskinesia Rating Scale (UDysRS) [Time frame: Baseline through 5 years post-transplantation]
Eligibility criteria
Inclusion criteria
- Subject received BRT-DA01 in Study MSK-DA01-101 (ie, parent study) and will have completed or discontinued the parent study
- Subject must be willing and able to provide written informed consent for the BRT-DA0-501 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures
Exclusion criteria
- No exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of California, Irvine — Orange
- Weill Cornell Medical College — New York
Canada · 1 center
- Toronto Western Hospital — Toronto
Identifiers
NCT: NCT05897957 · BRT-DA01-501