Restore dopamine to improve walking
- Trial ID
- NCT05901818
- Official Title
- Safety and Efficacy of Autologous Induced Neural Stem Cell-derived Dopaminergic Precursor Cells in the Treatment of Parkinson's Disease
- Goal
- Restore dopamine to improve walking
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Xuanwu Hospital, Beijing
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson's Disease
- Interventions
- Autologous induced neural stem cell-derived DA precursor cells
Summary For Families
They want to see if transplanting a patient’s own reprogrammed neural stem cells can safely replace the dopamine-producing neurons lost in Parkinson's, with the hope of improving movement and lowering medication needs. The team makes induced neural stem cells from the patient, grows them into dopaminergic precursor cells, and implants them into the brain so they can survive, make dopamine, and integrate into circuits; because the cells come from you there is less risk of immune rejection, and patients will initially stay on levodopa while doctors watch how the graft affects symptoms and medication. Enrollment is for people aged 30 to 85 who have had Parkinson's for more than 3 years, are Hoehn and Yahr stage 4 or less when medicated, and show at least a 30% motor improvement with levodopa. People with atypical or secondary parkinsonism, major other brain or systemic illnesses, significant cognitive impairment, severe dyskinesia, prior brain surgery, long-term anticoagulant use, MRI or PET contraindications, or pregnancy are excluded.
Locations
- Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Autologous induced neural stem cell-derived DA precursor cells. They want to see if transplanting a patient’s own reprogrammed neural stem cells can safely replace the dopamine-producing neurons lost in Parkinson's, with the hope of improving movement and lowering medication needs. The team makes induced neural stem cells from the patient, grows them into dopaminergic precursor cells, and implants them into the brain so they can survive, make dopamine, and integrate into circuits; because the cells come from you there is less risk of immune rejection, and patients will initially stay on levodopa while doctors watch how the graft affects symptoms and medication. Enrollment is for people aged 30 to 85 who have had Parkinson's for more than 3 years, are Hoehn and Yahr stage 4 or less when medicated, and show at least a 30% motor improvement with levodopa. People with atypical or secondary parkinsonism, major other brain or systemic illnesses, significant cognitive impairment, severe dyskinesia, prior brain surgery, long-term anticoagulant use, MRI or PET contraindications, or pregnancy are excluded.
- Who can participate?
- Participants must be between 30 Years and 85 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 2 years and 7 months.
- 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.