Trials / Enrolling By Invitation
Enrolling By InvitationNCT05897957
Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01
Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01, a Human Embryonic Stem Cell-Derived Midbrain Dopaminergic Neuronal Cell Therapy
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (estimated)
- Sponsor
- BlueRock Therapeutics · Industry
- Sex
- All
- Age
- 50 Years – 78 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Timeline
- Start date
- 2023-05-16
- Primary completion
- 2027-05-01
- Completion
- 2027-09-01
- First posted
- 2023-06-12
- Last updated
- 2024-04-12
Locations
3 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT05897957. Inclusion in this directory is not an endorsement.