NCR201 dopaminergic cell therapy for people with Parkinson's disease
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
PHASE1 · Nuwacell Biotechnologies Co., Ltd. · NCT06978920
This trial will try giving an allogeneic dopaminergic neural precursor cell treatment called NCR201 to people aged 40–75 with Parkinson's disease of more than five years who are on stable dopamine medication to see if it is safe and shows early benefit.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Nuwacell Biotechnologies Co., Ltd. (industry) |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06978920 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, interventional trial testing allogeneic dopaminergic neural precursor cells (NCR201) in people with Parkinson's disease to characterize safety, tolerability, and signals of preliminary efficacy. Eligible participants are 40–75 years old with a clinical diagnosis of Parkinson's disease for over five years, on a stable dose of dopaminergic medication, and able to undergo PET/CT/MRI imaging. Participants with prior brain surgery, prior stem cell therapy, cognitive impairment, serious systemic disease, or metastatic cancer are excluded. Outcomes will focus on adverse events, tolerability measures, and exploratory clinical and imaging markers of dopaminergic function.
Who should consider this trial
Good fit: Ideal candidates are people aged 40–75 with Parkinson's disease for more than five years who are on a stable dopamine regimen and are fit for brain imaging and cell therapy without major comorbidities.
Not a fit: Patients with cognitive impairment, a history of brain surgery, prior stem cell treatments, serious systemic illness, metastatic cancer, or atypical parkinsonism are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, NCR201 could offer a cell-based approach to replace lost dopaminergic function and potentially improve motor symptoms and quality of life.
How similar studies have performed: Related dopaminergic cell-transplant approaches have shown encouraging signals in preclinical work and small clinical series but remain experimental with mixed clinical outcomes to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages between 40 and 75 years; * Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria; * Disease history over 5 years; * Stable dose of dopamine treatment; * Able to undergo PET/CT/MRI detection; Exclusion Criteria: * Patients who have previously undergone brain surgery; * Past use of stem cell therapy or participation in stem cell clinical research; * Cognitive impairment; * History of mental disorders; * Patients with other serious systemic diseases; * Past or current metastatic malignant tumors.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of USTC — Hefei, Anhui, China (RECRUITING)
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.
Conditions: Parkinson Disease