Parkinsons Disease study: Bemdaneprocel
Official title A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
ClinicalTrials.gov ID: NCT06944522
What this study is testing
What is bemdaneprocel?
an investigational cell therapy being studied as a potential treatment for Parkinson's disease is designed to replace lost dopamine‑producing neurons in the brain
Also referred to as MSK-DA01, BRT-DA01.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether bemdaneprocel is effective and safe for people with Parkinson's disease.
- Who it's for
- Adults diagnosed with Parkinson's disease who meet the study’s eligibility criteria.
- What's involved
- Participants will be randomly assigned to receive either bemdaneprocel or a sham (placebo) surgery, and neither they nor the doctors will know which they get. Follow‑up visits and assessments will be done during the trial.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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
You likely can't join if
- PD presenting with recurrent falls
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease...
- Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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
- Any history or evidence of infection with HBV or HIV; any active infection with HCV, CMV, syphilis, or latent tuberculosis
- 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
- Unable to comply with study requirements for any reason
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Sun City, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Farmington Hills, Michigan, United States
- Buffalo, New York, United States
- New York, New York, United States
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Sun City, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States and 33 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.