Parkinson DiseaseEarly Phase 1NCT06583291
iDAP Injection in the Treatment of Parkinson's Disease
A Early Phase 1 study testing Allogeneic dopaminergic neural precursor cell(iDAP) in people with Parkinson Disease, run by Anhui Provincial Hospital.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Allogeneic dopaminergic neural precursor cell(iDAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Early 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 45 and 75 years;
- Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria;
- Disease history 4-20 years;
- Hoehn and Yahr Stage 2-4;
- Stable dose of dopamine for more than 3 months;
- Improvement of MDS-UPDRS part III;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Center, Open-label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Allogeneic Dopaminergic Neural Precursor Cell(iDAP) Injection in the Treatment of Parkinson's Disease
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients.
Read the detailed description
Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.
- Conditions
- Parkinson Disease
- Being tested
- Allogeneic dopaminergic neural precursor cell(iDAP)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic dopaminergic neural precursor cell(iDAP)Drug
Bilateral implantation
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | MRI-guided bilateral stereotactic cell implantation Receives: Drug: Allogeneic dopaminergic neural precursor cell(iDAP) |
| High dose | Experimental | MRI-guided bilateral stereotactic cell implantation Receives: Drug: Allogeneic dopaminergic neural precursor cell(iDAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events.
Safety and tolerability
Measured: Within 24 months post-transplantation
Secondary outcomes (8)
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
Measured: Within 24 months post-transplantation
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.
Higher scores mean a worse outcome.
Measured: Within 24 months post-transplantation
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Measured: Within 24 months post-transplantation
Assessment of changes in Mini-mental State Examination (MMSE), Hamilton Depression Scale (HAMD)-17 and Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Measured: Within 24 months post-transplantation
Assessment of changes in Activity of Daily Living Scale (ADL) in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in activity of daily living.
Measured: Within 24 months post-transplantation
Brain network connectivity patterns as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
Evidence of cell survival
Measured: Within 24 months post-transplantation
Brain DAT intake index as demonstrated on PET dopamine transporter(DAT) compared with baseline in the 'off' state.
Evidence of cell survival
Measured: Within 24 months post-transplantation
Patient L-dopa equivalent dose compared with baseline.
Measure of dopaminergic drug dose.
Measured: Within 24 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (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.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583291
- Sponsor's protocol ID
- NCR201-1001
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 4 Sep 2024
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Allogeneic Dopaminergic Neural Precursor Cell(iDAP) Injection in the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06583291
- Acronym / sponsor ID
- NCR201-1001
- Conditions
- Parkinson Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Sep 2024 (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.
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients.
Detailed description
Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Allogeneic dopaminergic neural precursor cell(iDAP)MRI-guided bilateral stereotactic cell implantation |
| High dose | Experimental | Drug: Allogeneic dopaminergic neural precursor cell(iDAP)MRI-guided bilateral stereotactic cell implantation |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages between 45 and 75 years;
- Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria;
- Disease history 4-20 years;
- Hoehn and Yahr Stage 2-4;
- Stable dose of dopamine for more than 3 months;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Allogeneic dopaminergic neural precursor cell(iDAP)Bilateral implantation | Drug | High dose, Low dose |
Primary outcome
Incidence and severity of adverse events.
Time frame: Within 24 months post-transplantation
Safety and tolerability
8 secondary outcomes
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Mini-mental State Examination (MMSE), Hamilton Depression Scale (HAMD)-17 and Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Activity of Daily Living Scale (ADL) in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Brain network connectivity patterns as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
Time frame: Within 24 months post-transplantation
Brain DAT intake index as demonstrated on PET dopamine transporter(DAT) compared with baseline in the 'off' state.
Time frame: Within 24 months post-transplantation
Patient L-dopa equivalent dose compared with baseline.
Time frame: Within 24 months post-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 4 Sep 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allogeneic dopaminergic neural precursor cell(iDAP) in people with Parkinson Disease, run by Anhui Provincial Hospital.
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 6 inclusion and 6 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jiong Shi, M.D (6228 3114, Jshi2022@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events. (time frame: Within 24 months post-transplantation). 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 4 Sep 2024.