Bemdaneprocel for Parkinson's Disease

(exPDite-2 Trial)

Recruiting at 17 trial locations

Overseen By Patient Engagement

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BlueRock Therapeutics

Must be taking: Levodopa

Must not be taking: Immunosuppressants

Disqualifiers: Epilepsy, Stroke, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of a new treatment called bemdaneprocel for people with Parkinson's Disease. Parkinson's affects movement, often causing tremors and stiffness. Participants will either receive the treatment or undergo a sham surgery, which mimics the real surgery without the actual treatment, to compare results. Suitable candidates have had Parkinson's for 4 to 12 years, are currently on medication, and experience at least 2.5 hours of "OFF-time" daily, when their medication isn’t working well. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be receiving medical therapy for Parkinson's symptoms, it seems likely you can continue your current treatment.

Is there any evidence suggesting that bemdaneprocel is likely to be safe for humans?

Research has shown that bemdaneprocel was safe in earlier studies. Patients with Parkinson's Disease who received this treatment were observed for up to 36 months. During this period, the treatment was generally well-tolerated, and no major safety issues were reported. These studies suggest that bemdaneprocel might be safe for people, based on past patient experiences. However, consulting a healthcare professional before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Bemdaneprocel is unique because it uses stem cell technology to address Parkinson's disease. Unlike the standard treatments like levodopa or dopamine agonists, which primarily manage symptoms by increasing dopamine levels in the brain, Bemdaneprocel aims to replace the lost or damaged dopamine-producing neurons. Researchers are excited about this approach because it has the potential to modify the disease process itself, rather than just alleviating symptoms, offering hope for a more transformative impact on patients' lives.

What evidence suggests that bemdaneprocel might be an effective treatment for Parkinson's Disease?

Research has shown that bemdaneprocel, a treatment under study in this trial for Parkinson's disease, produced promising results in earlier studies. In one 36-month study, patients maintained stable movement abilities, meaning their ability to move either improved or remained unchanged. The treatment was generally safe for patients. This therapy uses special cells to help restore brain function, potentially managing Parkinson's disease symptoms. These findings provide strong reason to believe that bemdaneprocel could effectively treat the condition. Participants in this trial will receive either bemdaneprocel or undergo a sham surgery as part of the study design. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

Adults with Parkinson's Disease are eligible for this trial. Participants must meet certain health criteria, which will be determined by the study team. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am currently on medication for Parkinson's disease symptoms.

I was diagnosed with Parkinson's disease between 4 and 12 years ago.

My condition improves with levodopa treatment.

Exclusion Criteria

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

Receipt of another investigational therapy

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bemdaneprocel or undergo sham surgery on Day 0, followed by an immunosuppression regimen

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bemdaneprocel
• Sham surgery

Trial Overview The trial is testing bemdaneprocel against a sham (fake) surgery to see if it's effective and safe in treating Parkinson's Disease. It's a Phase 3 study where participants are randomly assigned to either the real treatment or placebo, without knowing which they receive.

How Is the Trial Designed?

Group I: Group A Active Control 1 Intervention

Bemdaneprocel will be administered on Day 0

Group II: Group B Placebo Group 1 Intervention

Sham surgery will be performed on Day 0

Who Is Running the Clinical Trial?

BlueRock Therapeutics

Lead Sponsor

Trials

4

Recruited

270+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. bayer.com bayer.com/media/en-us/bluerock-therapeutics-reports-positive-36-month-results-from-phase-i-trial-of-bemdaneprocel-for-treating-parkinsons-disease/

BlueRock Therapeutics reports positive 36-month results ... BlueRock Therapeutics reports positive 36-month results from Phase I trial of bemdaneprocel for treating Parkinson's disease.

2. neurologylive.com neurologylive.com/view/cell-therapy-bemdaneprocel-continues-show-positive-effects-parkinson-disease-36-months

Cell Therapy Bemdaneprocel Continues to Show Positive ... Bemdaneprocel showed a favorable safety profile and stable motor outcomes at 36 months in a phase 1/2 trial for Parkinson's disease. The high- ...

3. bluerocktx.com bluerocktx.com/first-parkinsons-disease-patient-treated-in-bluerocks-pivotal-phase-iii-trial-of-investigational-cell-therapy-bemdaneprocel/

First Parkinson's disease patient treated in BlueRock's ... Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06944522

NCT06944522 | A Study to Investigate the Efficacy and ... A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease (exPDite-2) · Study Overview · Contacts and Locations.

5. nature.com nature.com/articles/s41586-025-08845-y

Phase I trial of hES cell-derived dopaminergic neurons for ... Secondary and exploratory clinical outcomes showed improvement or stability, including improvement in the Movement Disorder Society Unified ...

6. bayer.com bayer.com/en/us/news-stories/bemdaneprocel-for-treating-parkinsons

BlueRock Therapeutics reports positive 36-month results ... Investigational cell therapy bemdaneprocel continues to demonstrate a favorable safety profile at 36 months in Phase I trial participants.

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000208808

Results Through 24 Months From a Phase 1 Study (S37.005) To report the safety of bemdaneprocel and its impact on clinical outcomes in participants with PD through 24 months post transplantation.