PARKINSON DISEASE (Disorder)Phase 1NCR201-2004NCT07896187
A Phase 1 Study of NCR201 in Parkinson's Disease Patients With Prior DBS
A Phase 1 study testing NCR201 in people with PARKINSON DISEASE (Disorder) and Cell Therapy, run by Nuwacell Biotechnologies Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Cell Therapy, Human Induced Pluripotent Stem Cells
- What is being tested?
- NCR201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Nov 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 26 and 70 years (inclusive), male or female.
- Diagnosed with primary Parkinson's disease (consistent with Chinese Parkinson's Disease Diagnostic Criteria, 2016 version). The subject has previously undergone intracranial deep brain stimulation (DBS) implantation surgery, with disease duration ≥ 5 years.
- Modified Hoehn-Yahr stage 3-4 (inclusive) in the DBS ON and medication OFF state.
- MDS-UPDRS Part III score ≥30 in the DBS ON and medication OFF state; a positive Madopar challenge test (improvement rate of MDS-UPDRS Part III score ≥30%), and on a stable anti-Parkinsonian medication.
Who cannot join
- Atypical or secondary Parkinsonism.
- Subjects with persistent active infection, cerebrospinal fluid leak, or unhealed wounds in the previous brain surgical area; malfunction of implanted devices, electrode displacement, or other conditions judged by the investigator to pose significant risks to the subject or interfere with study assessments; subjects who are unable to safely complete protocol-specified MRI examinations under the conditions specified in the DBS system instructions and study site SOP (including but not limited to device/lead combinations that do not meet scanning requirements or other MRI contraindications); subjects with any contraindication to surgery or anesthesia as assessed by the investigator; or subjects with other prior surgical conditions deemed by the investigator to interfere with study participation.
- Head CT/MRI demonstrating brain trauma, cerebrovascular malformation, hydrocephalus, brain tumor, basal ganglia cerebral infarction lesions or other brain injuries, severe cerebral atrophy, or imaging abnormalities in the striatum or other brain regions that substantially increase surgical risk.
- Subjects with active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to signing the informed consent form, or subjects who cannot discontinue antiplatelet agents or other anticoagulant agents for at least 5 days prior to surgery.
- Subjects with any of the following: positive human immunodeficiency virus (HIV) antibody; positive Treponema pallidum antibody; positive hepatitis C virus (HCV) antibody with HCV RNA copy number greater than the lower limit of the assay normal range; positive hepatitis B virus (HBV) surface antigen with HBV DNA copy number greater than the lower limit of the assay normal range; active tuberculosis; or other active infections judged by the investigator that may interfere with subject participation or study outcomes.
- Subjects with dementia or severe cognitive impairment at screening.
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- Subjects with a significant history of psychiatric disorders at screening, or suffering from severe depression.
- Subjects who have participated in clinical trials of stem cell therapy or gene therapy for Parkinson's disease.
- History of severe allergy or hypersensitivity reactions.
- Subjects with alcohol addiction, or positive drug abuse screening test.
- Lactating women; female subjects with pregnancy or oocyte donation plans from study initiation through the follow-up period; male subjects (or their partners) with fertility or sperm donation plans from study initiation through the follow-up period and refuse to take contraceptive measures.
- Subjects with severe dyskinesia in the medication ON state.
- Other conditions that, in the investigator's opinion, would render the subject unsuitable for this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Jianguo Zhang, MD, +86 13601294613, zjguo73@126.com
About this study
Official title: A Phase 1, Open-Label, Single-Arm, 3+3 Dose-Escalation Clinical Trial of NCR201 Injection in Patients With Moderate-to-Advanced Primary Parkinson's Disease Previously Treated With Deep Brain Stimulation
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.
Read the detailed description
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.
- Conditions
- PARKINSON DISEASE (Disorder), Cell Therapy, Human Induced Pluripotent Stem Cells, Deep Brain Stimulation, Phase 1 Clinical Trial, Dopaminergic Progenitor Cells
- Being tested
- NCR201
- Keywords
- Parkinson Disease, Cell therapy, Human induced pluripotent stem cells, Deep brain stimulation, Phase 1 clinical trial, Hypoimmune dopaminergic progenitor cells, Putaminal injection, Hypoimmune cell product
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCR201Biological
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℃.
| Study group | Role | What they receive |
|---|---|---|
| NCR201 Treatment Group | Experimental | All enrolled participants will receive stereotactic putaminal injection of NCR201. This is a dose-escalation design. Receives: Biological: NCR201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Within 12 months after NCR201 transplantation
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a multi-center, open-label, sequential-assignment, dose-escalation Phase 1 trial following a standard 3+3 design. Participants are enrolled into successive dose cohorts. Two dose levels will be assessed: 4×10\^6 cells per side and 8×10\^6 cells per side. All participants will receive a single stereotactic bilateral putaminal injection of NCR201. The dose-limiting toxicity (DLT) observation period is 8 weeks post-dosing. A safety review must be completed before advancing to the next higher-dose cohort. No intra-participant dose escalation is permitted. Planned total enrollment is 6-12 participants.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianguo Zhang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896187
- Sponsor's protocol ID
- NCR201-2004
- Acronym
- NCR201-2004
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared externally, to protect participant privacy and comply with the requirements of the institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Arm, 3+3 Dose-Escalation Clinical Trial of NCR201 Injection in Patients With Moderate-to-Advanced Primary Parkinson's Disease Previously Treated With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT07896187
- Acronym / sponsor ID
- NCR201-2004 / NCR201-2004
- Conditions
- PARKINSON DISEASE (Disorder), Cell Therapy, Human Induced Pluripotent Stem Cells, Deep Brain Stimulation, Phase 1 Clinical Trial, Dopaminergic Progenitor Cells
- Keywords
- Parkinson Disease, Cell therapy, Human induced pluripotent stem cells, Deep brain stimulation, Phase 1 clinical trial, Hypoimmune dopaminergic progenitor cells, Putaminal injection, Hypoimmune cell product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-center, open-label, sequential-assignment, dose-escalation Phase 1 trial following a standard 3+3 design. Participants are enrolled into successive dose cohorts. Two dose levels will be assessed: 4×10^6 cells per side and 8×10^6 cells per side. All participants will receive a single stereotactic bilateral putaminal injection of NCR201. The dose-limiting toxicity (DLT) observation period is 8 weeks post-dosing. A safety review must be completed before advancing to the next higher-dose cohort. No intra-participant dose escalation is permitted. Planned total enrollment is 6-12 participants.
| Arm | Type | Receives |
|---|---|---|
| NCR201 Treatment Group | Experimental | Biological: NCR201All enrolled participants will receive stereotactic putaminal injection of NCR201. This is a dose-escalation design. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 26 and 70 years (inclusive), male or female.
- Diagnosed with primary Parkinson's disease (consistent with Chinese Parkinson's Disease Diagnostic Criteria, 2016 version). The subject has previously undergone intracranial deep brain stimulation (DBS) implantation surgery, with disease duration ≥ 5 years.
- Modified Hoehn-Yahr stage 3-4 (inclusive) in the DBS ON and medication OFF state.
- MDS-UPDRS Part III score ≥30 in the DBS ON and medication OFF state; a positive Madopar challenge test (improvement rate of MDS-UPDRS Part III score ≥30%), and on a stable anti-Parkinsonian medication.
Key exclusion criteria (13 listed)
- Atypical or secondary Parkinsonism.
- Subjects with persistent active infection, cerebrospinal fluid leak, or unhealed wounds in the previous brain surgical area; malfunction of implanted devices, electrode displacement, or other conditions judged by the investigator to pose significant risks to the subject or interfere with study assessments; subjects who are unable to safely complete protocol-specified MRI examinations under the conditions specified in the DBS system instructions and study site SOP (including but not limited to device/lead combinations that do not meet scanning requirements or other MRI contraindications); subjects with any contraindication to surgery or anesthesia as assessed by the investigator; or subjects with other prior surgical conditions deemed by the investigator to interfere with study participation.
- Head CT/MRI demonstrating brain trauma, cerebrovascular malformation, hydrocephalus, brain tumor, basal ganglia cerebral infarction lesions or other brain injuries, severe cerebral atrophy, or imaging abnormalities in the striatum or other brain regions that substantially increase surgical risk.
- Subjects with active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to signing the informed consent form, or subjects who cannot discontinue antiplatelet agents or other anticoagulant agents for at least 5 days prior to surgery.
- Subjects with any of the following: positive human immunodeficiency virus (HIV) antibody; positive Treponema pallidum antibody; positive hepatitis C virus (HCV) antibody with HCV RNA copy number greater than the lower limit of the assay normal range; positive hepatitis B virus (HBV) surface antigen with HBV DNA copy number greater than the lower limit of the assay normal range; active tuberculosis; or other active infections judged by the investigator that may interfere with subject participation or study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCR201NCR201 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℃. | Biological | NCR201 Treatment Group |
Primary outcome
Incidence of Adverse Events
Time frame: From the time of cell infusion up to 12 months after NCR201 transplantation
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).
Maximum Tolerated Dose (MTD) of NCR201
Time frame: Within 12 months after NCR201 transplantation
Change from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection.
9 secondary outcomes
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
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
Time frame: Baseline, 6 months and 12 months after NCR201 transplantation
Change in UPDRS Part II Activities of Daily Living Score
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Change in levodopa equivalent daily dose (LEDD)
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
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Incidence of anti-NCR201 alloantibody formation
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
Time frame: Baseline, 6 months and 12 months after NCR201 transplantation
Change in dyskinesia rating scale score
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Duration of on-time without troublesome dyskinesia
Time frame: Baseline, 3 months, 6 months and 12 months after NCR201 transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be shared externally, to protect participant privacy and comply with the requirements of the institutional review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianguo Zhang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NCR201 in people with PARKINSON DISEASE (Disorder) and Cell Therapy, run by Nuwacell Biotechnologies Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruidong Zhang (+86 18132430187, rdzhang@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: From the time of cell infusion up to 12 months after NCR201 transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.