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Bemdaneprocel for motor symptoms in adults with Parkinson's disease

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

Phase 3 Interventional BlueRock Therapeutics · NCT06944522

This Phase 3 study will test whether bemdaneprocel, a dopaminergic cell therapy, can improve motor symptoms in adults aged 45–75 with Parkinson's disease compared with sham surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment102 (estimated)
Ages45 Years to 75 Years
SexAll
SponsorBlueRock Therapeutics Industry-sponsored
Drugs / interventionsradiation
Locations39 sites (Sun City, Arizona and 38 other locations)
Trial IDNCT06944522 on ClinicalTrials.gov

What this trial studies

The BRT-DA01-301 Phase 3 trial is a multicenter, randomized, sham surgery-controlled, double-blind study enrolling about 102 adults with Parkinson's disease who meet specific levodopa- and dopamine-responsiveness criteria. Participants are randomized 2:1 to receive either bemdaneprocel (with an immunosuppression regimen) or sham surgery with placebo-equivalent procedures to maintain blinding. The primary outcome focuses on change in motor symptoms, and secondary outcomes include motor function, quality of life, non-motor symptoms, disease severity, and use of PD medications or therapies. Participants are followed for at least 18 months in the double-blind period and may be followed up to five years if they receive bemdaneprocel.

Who should consider this trial

Good fit: Ideal candidates are adults 45–75 years old, diagnosed with clinically established PD 4–12 years earlier, who have a clear response to levodopa/dopamine therapy, experience at least 2.5 hours of daily OFF-time, and can undergo immunosuppression and surgical procedures.

Not a fit: Patients with recurrent falls, signs of other neurodegenerative disorders, major excluded comorbidities, poor levodopa responsiveness, or outside the specified age and disease-duration window are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, bemdaneprocel could restore dopaminergic function enough to reduce OFF time and improve motor function and quality of life for people with mid-stage Parkinson's disease.

How similar studies have performed: Prior early-phase cell-therapy studies and related dopaminergic cell transplant approaches have shown promising signals but remain experimental and have not yet produced definitive phase 3–level evidence of long-term clinical benefit.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society
* Individual of any sex ≥45 to ≤75 years of age at informed consent
* Robust and clear response to DA therapy as defined by MDS-UPDRS Part III
* ≥4 and \<12 years from time of PD diagnosis at informed consent
* 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

Exclusion Criteria:

* 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
* 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
* Any active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, or tuberculosis) or condition that, in the opinion of the investigator could put the participant at significant risk from immunosuppression or impact the participant's ability to perform study assessments
* Current or previously active malignant disease within the past 5 years
* Chronic immunosuppressive therapy
* Receipt of another investigational therapy within 5 half-lives of the active treatment
* Pregnancy or breastfeeding

Where this trial is running

Sun City, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Parkinsons DiseaseexPDite-2Cell TherapyCellular TherapyDopaminergic Neuronal Cell Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.