Dopamine Neuron Transplantation for Parkinson's Disease
Trial Summary
What is the purpose of this trial?
This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell (iPSC)-derived dopamine neurons. This research study is a single-center Phase 1 clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot be on chronic anticoagulation medication (blood thinners) and should not have poorly controlled blood pressure or diabetes. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease?
Research shows that transplanting dopamine neurons derived from a patient's own cells can lead to motor improvements in animal models of Parkinson's disease, with successful neuron survival and growth. Additionally, a pioneering study demonstrated the feasibility of this approach in a human patient, suggesting potential for effective treatment.12345
Is dopamine neuron transplantation for Parkinson's disease safe in humans?
Preclinical studies in animals, including mice and primates, show that dopamine neuron transplantation using induced pluripotent stem cells (iPSCs) does not cause tumors or toxicity and is considered safe. These studies support the potential for safe use in humans, although long-term human data is still needed.12678
How is the treatment of autologous iPSC-derived dopamine neuron transplantation unique for Parkinson's disease?
Eligibility Criteria
This trial is for individuals with Parkinson's Disease who are eligible to undergo a surgical procedure where investigational cells will be injected into their brain. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive autologous iPSC-derived dopamine neuron transplantation into the putamen
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in Parkinson's disease symptoms
Treatment Details
Interventions
- Autologous iPSC-Derived Dopamine Neuron Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Penelope J. Hallett, Ph.D.
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Oryon Cell Therapies
Collaborator