This study is accepting new patients by invitation only

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

a study on Parkinson's Disease Neurodegenerative Disease

Summary

Eligibility
for people ages 50-78 (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Claire Henchcliffe

Description

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.

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

Details

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.

Keywords

Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases

Eligibility

You can join if…

Open to people ages 50-78

  • 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

You CAN'T join if...

  • No exclusion criteria

Locations

  • University of California, Irvine
    Orange California 92868 United States
  • Toronto Western Hospital
    Toronto Ontario M5T 2S8 Canada
  • Weill Cornell Medical College
    New York New York 10065 United States

Lead Scientist at UC Irvine

  • Claire Henchcliffe
    Clinical Professor, Neurology, School of Medicine. Authored (or co-authored) 84 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
BlueRock Therapeutics
ID
NCT05897957
Study Type
Observational
Participants
Expecting 12 study participants
Last Updated