NCT04802733CompletedPhase 1
Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease
Phase 1 Study To Assess the Safety and Tolerability of Human Embryonic Stem Cell-Derived Midbrain Dopamine Neuron Cell Therapy (MSK-DA01) For Advanced Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 1 Nov 2024
Brief summary (registry, in English)
This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 12 Mar 2021
- Start date
- 3 May 2021
- Primary completion date
- 18 May 2023
- Lead sponsor
- BlueRock Therapeutics
- Diseases
- Parkinson disease
- NCT number
- NCT04802733
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 3 May 2021 to the primary completion date, 18 May 2023
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior Deep Brain Stimulation , lesion therapy, or gene therapy for PD
- Prior surgical or radiation therapy to the brain or spinal cord
- Previous or currently active malignant disease within the past 5 years, except basal cell carcinoma or in situ uterine cervical carcinoma that have been treated
- Contraindication to surgery or general anesthesia
Other illness
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease
- Any medical condition resulting in high risk of immunosuppressive drugs, including any active infectious disease
- Severe obesity (\>350 lbs) or any condition that prevents use of PET/MRI
- In the opinion of the investigator, any other condition regarded as making subject unsuitable for trial
Lab values
- Inability to temporarily stop anti-platelet agents or other anti-coagulant medications without serious risk
Other
- Pregnancy or breastfeeding
Who the study is looking for
- Age 50-78 years old (Canada)
- Age 60-78 years old (United States)
- Diagnosis of Parkinson's Disease made between 3 to 20 years ago
- Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
- Able to participate in all study visits and evaluations, including brain MRI and PET scan
- Existence of a study partner who may act as potential surrogate over long term for ongoing consent
Age in the registry: 50 years to 78 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.