Parkinson DiseasePhase 1NCT06821529
Stereotactic Intracerebral Injection of IPSC-DAPs in Patients with Parkinson's Disease
A Phase 1 study testing ICA07 therapy in people with Parkinson Disease, run by iCamuno Biotherapeutics Ltd. at 1 site in China.
Trial summary
Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Read more about this study
- Who is it for?
- Ages 39 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ICA07 therapy
- 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
- 15 May 2025to 30 Sep 2026
- 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 39 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to sign informed consent and comply with the study protocol
- 39-75 years of age, at the time of signing informed consent
- Diagnosed to be Parkinson's disease patients over 5 years
- Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
- At least 3 hours accumulative "off" time per day
- Hoehn and Yahr Stage 2.5 - 4 in the off state at screening
- Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale
Who cannot join
- Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack
- Patient with unstable vital sign at screening and/or prior to the surgery:
- Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
- Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- Hematologic abnormality: hemoglobin <10 mg/dL or platelet count < 100,000/mL
- International normalized ratio (INR) ≥ 1.3 not due to a reversible cause
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- Patients with autoimmune disorders
- Patients with HIV and/or active HBV or HCV
- Patients who are unable to undergo MRI and PET/CT
- Patients with an expected life expectancy of <1 year
- Patients who have had active malignancies
- Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment
- Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery
- Received cell or gene therapy (autologous or allogeneic) within the previous 12 months
- Participation in an investigational therapeutic or device trial within 30 days of consent
- Women who are pregnant or breast-feeding
- Other conditions that researchers consider not suitable to participate in this 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
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Stereotactic Intracerebral Injection of Autologous Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients with Parkinson's Disease
Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.
Read the detailed description
Patients with Parkinson's disease will be treated with autologous induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.
- Conditions
- Parkinson Disease
- Being tested
- ICA07 therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICA07 therapyBiological
4 million iPSC-DAPs will be administrated into the putamen on each side of the brain
| Study group | Role | What they receive |
|---|---|---|
| ICA07 therapy | Experimental | Stereotactic Intracerebral Injection of 4 million iPSC-DAPs into the putamen on each side of the brain . Receives: Biological: ICA07 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and servility of Treatment-Emergent Adverse Events
Incidence of adverse event (AE), serious adverse event(SAE) is defined as the composite of number and severity of adverse events, regardless of causality, clinical laboratory abnormalities, clinical meaningful changes from baseline
Measured: From baseline to 12 months post surgery
Secondary outcomes (5)
changes in motor function
Changes in motor function that measured by Movement and Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III. TheMDA- UPDRS Part III score ranges from 0 to 132, with higher score indicating greater disability
Measured: From baseline to 12 months post surgery
Changes in the Hoehn and Yahr scale
Hoehn and Yahr scale is used to provide a general estimate of clinical function of PD patients, combining functional deficits (disability) and objective signs (impairment). The Hoehn and Yahr score ranges from 0 to 5, with higher score indicating higher dysfunction of PD patients
Measured: From baseline to 12 months post surgery
Changes in quality of life (QoL)
Measured by Parkinson's Disease Quality of Life Rating Scale (PDQ-39) from baseline to 12 months post surgery.
PDQ-39 score ranges from 0 to 156 and provides the evidence of the quality of life of a PD patient. The higher the score, the lower the quality of life of PD patients.
Measured: From baseline to 12 months post surgery
Change in PD medication usage
Change in the Parkinson's disease medication usage as defined by the levodopa equivalent daily dose (LEDD)
Measured: From baseline to 12 months post surgery
18-F DAT PET uptake
Changes in putamen 18F DAT PET uptake that measured by PET/CT
Measured: Baseline, 6 and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start15 May 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iCamuno Biotherapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baorong Zhang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineGao Chen, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821529
- Sponsor's protocol ID
- (2025)LSYD(0172)H
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Intracerebral Injection of Autologous Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06821529
- Acronym / sponsor ID
- (2025)LSYD(0172)H
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- iCamuno Biotherapeutics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.
Detailed description
Patients with Parkinson's disease will be treated with autologous induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICA07 therapy | Experimental | Biological: ICA07 therapyStereotactic Intracerebral Injection of 4 million iPSC-DAPs into the putamen on each side of the brain . |
Who may qualify
- Ages
- 39 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to sign informed consent and comply with the study protocol
- 39-75 years of age, at the time of signing informed consent
- Diagnosed to be Parkinson's disease patients over 5 years
- Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
- At least 3 hours accumulative "off" time per day
Key exclusion criteria (17 listed)
- Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack
- Patient with unstable vital sign at screening and/or prior to the surgery:
- Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
- Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- Hematologic abnormality: hemoglobin <10 mg/dL or platelet count < 100,000/mL
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 |
|---|---|---|
| ICA07 therapy4 million iPSC-DAPs will be administrated into the putamen on each side of the brain | Biological | ICA07 therapy |
Primary outcome
Incidence and servility of Treatment-Emergent Adverse Events
Time frame: From baseline to 12 months post surgery
Incidence of adverse event (AE), serious adverse event(SAE) is defined as the composite of number and severity of adverse events, regardless of causality, clinical laboratory abnormalities, clinical meaningful changes from baseline
5 secondary outcomes
changes in motor function
Time frame: From baseline to 12 months post surgery
Changes in the Hoehn and Yahr scale
Time frame: From baseline to 12 months post surgery
Changes in quality of life (QoL)
Time frame: From baseline to 12 months post surgery
Change in PD medication usage
Time frame: From baseline to 12 months post surgery
18-F DAT PET uptake
Time frame: Baseline, 6 and 12 months post surgery
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 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Baorong Zhang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Gao Chen principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 ICA07 therapy in people with Parkinson Disease, run by iCamuno Biotherapeutics 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 7 inclusion and 17 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 12 Feb 2025. 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 Jiali Pu, PhD (+86 13989468062, jialipu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and servility of Treatment-Emergent Adverse Events (time frame: From baseline to 12 months post surgery). 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 12 Feb 2025.