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

N/AEnrolling By InvitationNCT05897957

BlueRock Therapeutics12 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Parkinson Disease

Eligibility

Sex: ALLMin age: 50 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (3)

University of California, Irvine

Orange, California, United States

Weill Cornell Medical College

New York, New York, United States

Toronto Western Hospital

Toronto, Ontario, Canada