A Phase 1 interventional study of NCR201 in PARKINSON DISEASE (Disorder), Cell Therapy and Human Induced Pluripotent Stem Cells, sponsored by Nuwacell Biotechnologies Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Nuwacell Biotechnologies Co., Ltd. · Phase 1, Interventional, and Treatment
This is a Phase 1 clinical trial to evaluate the safety and tolerability of a new cell therapy called NCR201. The study will enroll adults with moderate-to-advanced primary Parkinson's disease who have previously undergone deep brain stimulation (DBS) surgery.
NCR201 is an investigational cell therapy derived from hypoimmune human induced pluripotent stem cells (iPSCs). Participants will receive a one-time surgical injection of NCR201 directly into a specific brain region (the putamen) on both sides. The study will use a standard "3+3" design to test two different doses: a low-dose group (4 million cells per side) and a high-dose group (8 million cells per side).
The primary goal of this study is to check for any severe, dose-limiting side effects within the first 8 weeks after surgery, and to determine the maximum tolerated dose or the recommended dose for future Phase 2 studies. Researchers will also look for any initial signs of clinical benefit. Participants will be closely monitored through regular safety and symptom assessments for up to 96 weeks, with an optional long-term safety follow-up lasting an additional 3 to 5 years.
Parkinson's disease (PD) is a progressive neurodegenerative disease caused by the loss of dopaminergic neurons in the substantia nigra of the brain. Current treatments, including oral levodopa medication and deep brain stimulation (DBS), can only relieve symptoms but cannot restore the damaged dopaminergic neurons. For patients with moderate-to-advanced primary PD whose symptoms continue to progress after DBS surgery, there remains a critical unmet clinical need.
NCR201 is an off-the-shelf, hypoimmune dopaminergic progenitor cell product derived from human induced pluripotent stem cells. Preclinical studies demonstrated that NCR201 cells can survive in the brain, differentiate into functional dopaminergic neurons, and secrete dopamine, with no evidence of tumorigenic risk. Previous investigator-initiated clinical data showed favorable safety signals and symptom improvement in PD subjects, including patients with prior DBS.
This is a multi-center trial planned to enroll 6-12 participants. Eligible subjects must have a confirmed diagnosis of primary PD for at least 5 years, and their DBS surgery must have been performed at least 3 years before study consent. After stereotactic bilateral intraputaminal cell injection, participants will receive a 6-month immunosuppressive regimen to prevent graft rejection. Existing anti-Parkinson medications may be maintained and adjusted as needed during the trial, while DBS settings will be kept stable whenever possible.
Study assessments include motor and non-motor symptom scales, daily OFF/ON time, dyskinesia evaluation, quality of life questionnaires, and brain MRI and ¹⁸F-DOPA PET-CT scans. Safety surveillance will focus on adverse events including intracranial hemorrhage, brain infection, seizure, and graft overgrowth. The trial will also collect exploratory data on immune responses and changes in the levodopa equivalent daily dose.
4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Nuwacell Biotechnologies Co., Ltd. is the lead sponsor of 10 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
All enrolled participants will receive stereotactic putaminal injection of NCR201. This is a dose-escalation design.
Biological: NCR201
NCR201 is human induced pluripotent stem cell (iPSC)-derived hypoimmune dopaminergic progenitor cell injection. It is administered via single stereotactic putaminal injection at dose level of either 4x10\^6 cells per side or 8x10\^6 cells per side. Product specification: 2.4x10\^7 cells /0.3 mL per vial, stored and transported under 2-8℃.
Incidence of Adverse Events
To evaluate the safety and tolerability of stereotactic intracerebral injection of NCR201 by assessing the type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: From the time of cell infusion up to 12 months after NCR201 transplantation
Maximum Tolerated Dose (MTD) of NCR201
Change from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection.
Time frame: Within 12 months after NCR201 transplantation
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
Change from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection.
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Survival and engraftment of grafted cells assessed by brain PET/MRI imaging
Brain PET and MRI imaging to evaluate the survival, location and engraftment of transplanted NCR201 dopaminergic progenitor cells in the putamen.
Time frame: Baseline, 6 months and 12 months after NCR201 transplantation
Change in UPDRS Part II Activities of Daily Living Score
Change from baseline in UPDRS Part II score to assess activities of daily living in Parkinson's subjects after NCR201 treatment.
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Change in levodopa equivalent daily dose (LEDD)
Change from baseline in levodopa equivalent daily dose (LEDD) to assess reduction of anti-parkinson medication requirement.
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Change in UPDRS Part I Non-motor Experiences of Daily Living Score
Change from baseline in UPDRS Part I score to evaluate non-motor symptoms in Parkinson's patients receiving NCR201.
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Incidence of anti-NCR201 alloantibody formation
Detection of anti-donor alloantibodies in peripheral blood to assess immune response against transplanted NCR201 cells.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months after NCR201 transplantation
Change in Parkinson's Disease Questionnaire (PDQ-39) quality of life score
Change from baseline in PDQ-39 total score to evaluate health-related quality of life after NCR201 cell transplantation.
Time frame: Baseline, 6 months and 12 months after NCR201 transplantation
Change in dyskinesia rating scale score
Change from baseline in dyskinesia rating scale to assess the severity of levodopa-induced dyskinesia.
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Duration of on-time without troublesome dyskinesia
Assessment of daily "on" time without troublesome dyskinesia based on patient diaries after NCR201 treatment.
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Plan to share: No — The individual participant data will not be shared externally, to protect participant privacy and comply with the requirements of the institutional review board.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
Of 124 industry-sponsored phase 1 interventional studies under Parkinson Disease, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 23 months is above that.
Counting every sponsor, half of 201 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Nuwacell Biotechnologies Co., Ltd.