RECRUITING

A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

Conditions

Parkinsons Disease (PD)exPDite-2 Cell Therapy Cellular Therapy Dopaminergic Neuronal Cell Therapy Parkinsons Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).

Official Title

exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinson's Disease

Quick Facts

Study Start:2025-05

Study Completion:2032-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06944522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Individual of any sex ≥45 to ≤75 years of age at informed consent 2. Diagnosis of clinically established PD 3. ≥4 and \<12 years from time of PD diagnosis at informed consent 4. Must demonstrate responsiveness to levodopa therapy 5. Receiving medical therapy for the treatment of PD symptoms 6. ≥2.5 hours of daily OFF-time	1. PD presenting with recurrent falls 2. Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia 3. Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment 4. History of gene therapy or cell therapy 5. Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery 6. Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs 7. Current or previously active malignant disease within the past 5 years 8. Chronic immunosuppressive therapy 9. Receipt of another investigational therapy 10. Pregnancy or breastfeeding

Inclusion Criteria

Exclusion Criteria

1. Individual of any sex ≥45 to ≤75 years of age at informed consent
2. Diagnosis of clinically established PD
3. ≥4 and \<12 years from time of PD diagnosis at informed consent
4. Must demonstrate responsiveness to levodopa therapy
5. Receiving medical therapy for the treatment of PD symptoms
6. ≥2.5 hours of daily OFF-time

1. PD presenting with recurrent falls
2. Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia
3. Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment
4. History of gene therapy or cell therapy
5. Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
6. Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs
7. Current or previously active malignant disease within the past 5 years
8. Chronic immunosuppressive therapy
9. Receipt of another investigational therapy
10. Pregnancy or breastfeeding

Contacts and Locations

Study Contact

Patient Engagement

CONTACT

1-877-380-3967

clinicaltrials@bluerocktx.com

Study Locations (Sites)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160-8500

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696

United States

Quest Research Institute

Farmington Hills, Michigan, 48334

United States

New York Presbyterian/Weill Cornell Medical Center

New York, New York, 10065

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Collaborators and Investigators

Sponsor: BlueRock Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2032-03

Study Record Updates

Study Start Date2025-05

Study Completion Date2032-03

Terms related to this study

Keywords Provided by Researchers

exPDite-2
Cell Therapy
Cellular Therapy
Dopaminergic Neuronal Cell Therapy
Parkinsons Disease

Additional Relevant MeSH Terms

Parkinsons Disease (PD)