Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01

BlueRock Therapeutics

Status: Invitation-only

Conditions: Parkinson Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05897957

BRT-DA01-501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 50 to 78 years old

Volunteers: No Healthy Volunteers

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