RecruitingPhase 3interventionalRules rewrite

Phase 3: testing bemdaneprocel for Parkinsons Disease (PD)

Study BRT-DA01-301 is a Phase 3 multicenter, randomly assigned, sham surgery-controlled, neither you nor the study doctors know who gets the real treatment study to assess how well it works and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).

Official registry: https://clinicaltrials.gov/study/NCT06944522 · BlueRock Therapeutics · enrollment listed as 102

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are bemdaneprocel, or Sham surgery. The registry lists allocation as randomized. Study BRT-DA01-301 is a Phase 3 multicenter, randomly assigned, sham surgery-controlled, neither you nor the study doctors know who gets the real treatment study to assess how well it works and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).

They plan to enroll about 102 people at 43 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: bemdaneprocel, Sham surgery

Primary outcome (registry wording): Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day

Who it is for (from inclusion criteria)

Ages 45 Years to 75 Years
Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society
Robust and clear response to DA therapy as defined by MDS-UPDRS Part III
Must demonstrate responsiveness to levodopa therapy
Receiving medical therapy for the treatment of PD symptoms
≥2.5 hours of daily OFF-time
Vaccinated per current national guidelines or local practice for patients with altered immunocompetence

Who the registry excludes

PD presenting with recurrent falls
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
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
History of gene therapy or cell therapy for a neurological or intercerebral condition
Prior treatment with intrajejunal or subcutaneous infusion therapies for PD
Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI

Public study contact (from the registry)

Patient Engagement

1-877-380-3967

clinicaltrials@bluerocktx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

43 listed

Mayo Clinic Scottsdale - Neurology — Scottsdale, Arizona (recruiting)
Banner Sun Health Research Institute — Sun City, Arizona (recruiting)
University of Arkansas for Medical Sciences — Little Rock, Arkansas (recruiting)
UCLA NeuroTranslational Research Center — Los Angeles, California (recruiting)
UCI Medical Center - Neurology — Orange, California (recruiting)
Stanford Neuroscience Health Center — Palo Alto, California (recruiting)
University of Colorado Hospital - Neurology Clinic — Aurora, Colorado (recruiting)
MedStar Georgetown University Hospital — Washington D.C., District of Columbia (recruiting)
Mayo Clinic Jacksonville - Neurology — Jacksonville, Florida (recruiting)
University of Miami Health System - Neurology — Miami, Florida (recruiting)
USF Parkinson's Disease and Movement Disorders Center — Tampa, Florida (recruiting)
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital — Chicago, Illinois (recruiting)

+ 9 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06944522 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06944522?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06944522?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary