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A Study of Bemdaneprocel for Parkinson's Disease

This study is looking at an investigational cell therapy called bemdaneprocel for adults with Parkinson's Disease (PD). Bemdaneprocel is made from human embryonic stem cells and is designed to help with PD symptoms. You might be able to join if you are 45 to 75 years old, have a clear response to your current Parkinson's medication, and were diagnosed with PD 4 to 12 years ago. The study aims to see if bemdaneprocel can improve your "ON-time" (periods when your medication is working well) without troublesome dyskinesia (involuntary movements). This study is currently recruiting about 102 participants.

Study design
This is a Phase 3, randomized, double-blind study where participants will either receive bemdaneprocel or undergo a sham surgery. Approximately 102 adults with Parkinson's Disease will participate.
What's involved
Participants will undergo a procedure (either bemdaneprocel or sham surgery) and will be followed for at least 18 months, and up to five years if they receive bemdaneprocel. The study involves an immunosuppression regimen.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 18 months in the double-blind period, and up to five years if they receive bemdaneprocel.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06944522

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

Recruiting
PHASE3Ages 45–75InterventionalTreatment
BlueRock Therapeutics
~102 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:bemdaneprocelSham surgery

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day
Measured over From baseline to Week 78

Conditions

Parkinsons Disease (PD)

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NCT06944522

Where you'd take part

This study runs at 43 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner Sun Health Research Institute

    Sun City, Arizonastudy coordinator listed

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • CHUM - Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, Canadastudy coordinator listed

    Recruiting

  • Duke Neurological Disorders Clinic

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • EvergreenHealth - Research Department

    Kirkland, Washingtonstudy coordinator listed

    Recruiting

  • Gold Coast Hospital & Health Service

    Southport, Queensland, Australiastudy coordinator listed

    Recruiting

  • Johns Hopkins Hospital - Neurology

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Mayo Clinic Jacksonville - Neurology

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Patient Engagement
[email protected]
1-877-380-3967
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking dayFrom baseline to Week 78