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Enrolling by Invitation

NCT Number: NCT05897957

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies

Age range

50 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital, Toronto, Ontario, Canada

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About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total SAEs and total number of subjects with at least 1 SAE

    Time frame: Baseline through 5 years post-transplantation

    Total SAEs and total number of subjects with at least 1 SAE related to cellular drug product

Secondary outcomes

  1. Change in striatal 18F-DOPA uptake using positron emission tomography (PET)

    Time frame: Baseline through 5 years post-transplantation

    Change in striatal 18F-DOPA uptake using positron emission tomography (PET)

  2. Change in Hauser PD diary measurements

    Time frame: Baseline through 5 years post-transplantation

    Change in Hauser PD diary measurements

  3. 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 the MDS-UPDRS

  4. Change in levodopa equivalent daily dose (LEDD)

    Time frame: Baseline through 5 years post-transplantation

    Change in LEDD

  5. Change in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index

    Time frame: Baseline through 5 years post-transplantation

    Change in PDQ-39

  6. Change in the Unified Dyskinesia Rating Scale (UDysRS)

    Time frame: Baseline through 5 years post-transplantation

    Change in UDysRS

Other outcomes

  1. Adverse Events

    Time frame: Baseline through 5 years post-transplantation

    AEs related to the cellular drug product

  2. Change in modified Schwab and England Activities of Daily Living (mSEADL) scale

    Time frame: Baseline through 5 years post-transplantation

    Change in mSEADL

  3. Change in brain atrophy using MRI

    Time frame: Baseline through 5 years post-transplantation

    Change in brain atrophy using MRI

  4. Subjects using alternative advanced treatment options in Parkin's Disease

    Time frame: Baseline through 5 years post-transplantation

    Number of subjects using alternative advanced treatment options in PD (eg, CSAI, LCIG, DBS, focused ultrasound ablation)

Sponsors and collaborators

Lead sponsor

BlueRock Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2023
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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