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)
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.