Donor cell injections reduce tremor
- Trial ID
- NCT06978920
- Official Title
- A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
- Goal
- Donor cell injections reduce tremor
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 48 participants
- Conditions
- Parkinson Disease
- Interventions
- Allogeneic dopaminergic neural precursor cell(NCR201)
Plain-Language Summary
A Phase 1 effort to see if giving lab-made, donor-derived dopamine progenitor cells can be safely tolerated and show early signs of replacing the lost dopamine neurons that cause Parkinson's symptoms. The treatment is an injection of human induced pluripotent stem cell derived dopaminergic precursor cells, meant to engraft in the brain and produce dopamine to supplement existing levodopa or other dopamine therapies, with the main goals of checking safety, tolerability, and any initial benefit. The trial seeks people 40 to 75 years old with Parkinson's for more than five years who are on a stable dose of dopamine medication and can have PET/CT/MRI, and excludes those with prior brain surgery, prior stem cell therapy, significant cognitive or psychiatric problems, serious systemic illness, or a history of metastatic cancer.
Locations
- The First Affiliated Hospital of USTC, Hefei, Anhui, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Allogeneic dopaminergic neural precursor cell(NCR201). A Phase 1 effort to see if giving lab-made, donor-derived dopamine progenitor cells can be safely tolerated and show early signs of replacing the lost dopamine neurons that cause Parkinson's symptoms. The treatment is an injection of human induced pluripotent stem cell derived dopaminergic precursor cells, meant to engraft in the brain and produce dopamine to supplement existing levodopa or other dopamine therapies, with the main goals of checking safety, tolerability, and any initial benefit. The trial seeks people 40 to 75 years old with Parkinson's for more than five years who are on a stable dose of dopamine medication and can have PET/CT/MRI, and excludes those with prior brain surgery, prior stem cell therapy, significant cognitive or psychiatric problems, serious systemic illness, or a history of metastatic cancer.
- Who can participate?
- Participants must be between 40 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 1 month.