Using patients' own stem cells to treat Parkinson's Disease
Safety and Efficacy of Autologous Induced Neural Stem Cell-derived Dopaminergic Precursor Cells in the Treatment of Parkinson's Disease
This study is testing whether using patients' own stem cells can help improve symptoms of Parkinson's Disease safely.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05901818 on ClinicalTrials.gov |
What this trial studies
This phase I clinical study aims to evaluate the safety and efficacy of transplanting autologous induced neural stem cell-derived dopamine precursor cells into the brains of patients with Parkinson's Disease. The study involves reprogramming patients' peripheral blood mononuclear cells to create dopaminergic neural precursor cells, which are then injected into the striatum using stereotaxic techniques. Participants will be monitored for safety, tolerability, and improvements in Parkinson's symptoms over a period of up to 12 months post-transplantation.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 85 with a diagnosis of Parkinson's Disease for at least three years, who are responsive to levodopa treatment.
Not a fit: Patients with atypical Parkinsonian syndromes, severe psychiatric disorders, or those who have undergone previous brain surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option that may improve symptoms and quality of life for patients with Parkinson's Disease.
How similar studies have performed: While the use of autologous stem cells in treating neurodegenerative diseases is a growing field, this specific approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Ages between 30 and 85 years, males or females; Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria; Disease history over 3 years; Hoehn and Yahr Stage less than or equal to 4 during the medication "on" time; Responsive to levodopa treatment (Maximum rate of improvement in MDS-UPDRS, part 3, is over 30%). Exclusion Criteria: Atypical Parkinsonian syndrome or secondary Parkinsonian syndrome; Accompanied with other central nervous system diseases; With other severe systemic diseases or dysfunction; With severe psychiatric disorders; Subjects are using hormone or cytotoxic drugs and cannot stop taking the drug during the trial; With cognitive disorders (MMSE\<24); With severe dyskinesia (MDS-UPDRS part 4, score in 4.1/4.2 ≥ 2); Subjects have undergone previous brain surgery; Subjects are long-term user of anticoagulant; Subjects have intracranial lesions which may affect the surgery or follow-up studies as assessed by imaging; Subjects are unable to undergo MRI or AV133 PET examination; Pregnancy or in preparation for pregnancy; Not suitable to participate in this clinical trial as assessed by the study investigators/physicians.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhiguo Chen, Ph.D.
- Email: chenzhiguo@gmail.com
- Phone: +86-10-83198889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.