Idiopathic Parkinson's DiseasePhase 1NCT05691114
Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
A Phase 1 study testing hAESCs in people with Idiopathic Parkinson's Disease, run by Shanghai East Hospital at 1 site in China.
Trial summary
This is a single-center, single-arm, dose escalation study, to explore the safety, tolerability and efficacy of human amniotic epithelial stem cells (hAESCs) for idiopathic Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- hAESCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Feb 2023to Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 40-70 years old, with more than 5 years of idiopathic PD history
- UPDRS-III off-time scores ≤49
- MMSE scores ≥24
- HAMD-17 scores < 25
- H-Y on-time scores ≤4
- reactive to levodopa or dopa agonists
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- PD medication dose is stable for more than 2 months
- no general anesthesia contraindications, no stereotactic surgery contraindications or other conditions that interfere with clinical evaluation
- no abnormalities affecting cell transplantation by cranial MRI
- no participation of other clinical trials 3 months before signing the informed consent
Who cannot join
- secondary PD or Parkinson's syndrome
- subcutaneous apomorphine treatment
- scoring ≥ 2 on UPDRS-I item 2, or ≥ 2 on UPDRS-II item 13; or ≥ 3 on UPDRS-II item14
- history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consent
- history of seizures or prophylactic application of antiepileptic drugs
- other serious central nervous system disorders
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- history of stem cell therapy
- subject who had undergone a major surgery within 3 months and will undergo a major surgery within the next 6 months prior to signing informed consent
- autoimmune disease or current use of Immunosuppressants
- subjects with comorbid cardiac disease, for example, but not limited to, ischemic heart disease, congestive heart failure, significant arrhythmias or cardiac conduction block
- poorly controlled hypertension, diabetes mellitus, or comorbid endocrine system disorders, pulmonary disorders, gastrointestinal system disorders, serious infections, malignancies, etc.
- positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or Treponema pallidum antibody
- abnormalities in liver or kidney function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) or creatinine(Cr) are less than 1.5 times the upper limit of normal, or serum albumin < 30.0 g/L
- abnormalities in hematologic test: coagulation disorders or ongoing anticoagulation therapy; moderate to severe anemia; platelet count < 80 × 10^9/L
- inability to undergo MRI and positron emission tomography (PET) examinations
- subject with severe allergies
- women of childbearing potential (WOCBP) or subject is a man with a WOCBP partner, who are unwilling to take contraception during the trial
- pregnant or lactating females
- other conditions deemed by the investigator to be inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
Jingwen Wu, M.D., 18916111526, wujingwendongfang@163.com
About this study
This is a single-center, single-arm, dose escalation study, to explore the safety, tolerability and efficacy of human amniotic epithelial stem cells (hAESCs) for idiopathic Parkinson's disease (PD).
Read the detailed description
hAESCs will be administration through the Ommaya reservoir implanted into the lateral ventricle of subjects with idiopathic PD.
This dose escalation will be followed by an exploratory expansion phase in 3 cohorts.
- Dose A (5×10^7 cells/dose)
- Dose B (1.0×10^8 cells/dose)
- Dose C (1.5×10^8 cells/dose).
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- hAESCs
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAESCsBiological
human Amniotic Epithelial Stem Cells
| Study group | Role | What they receive |
|---|---|---|
| hAESCs treatment | Experimental | hAESCs will be administration through Ommaya reservoir implanted into the lateral ventricle.
The tolerability, safety, and efficacy will be examined of 4 monthly doses of hAESCs for 3 months followed by 2 doses every 3 months in dose escalation through 3 cohorts.
* Dose A (5×10^7 cells/dose)
* Dose B (1.0×10^8 cells/dose)
* Dose C (1.5×10^8 cells/dose). Receives: Biological: hAESCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
The occurrence of DLT.
Measured: 12 months
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest (AESI)
According to CTCAE V5.0, AE, SAE and AESI evaluated by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions.
AESI is defined as intracranial infection, hemorrhage, rejection, edema, as well as acute allergic reactions and ectopic mass formation associated with the therapy.
Measured: 12 Months
Secondary outcomes (9)
Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Measured: 12 months
Change from baseline in the UPDRS off-time total scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Measured: 12 months
Change from baseline in the UPDRS on-time total scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Measured: 12 months
Change from baseline in sum of the UPDRS-II and UPDRS-III scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Measured: 12 months
Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores
The PDQ-39 is a self-completed questionnaire assessing how often people with Parkinson's experience difficulties across 8 dimensions of daily living with 39 questions . Questions are answered using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each scores range from 0 = never have difficulty to 100 = always have difficulty.The higher the score, the lower the quality of life of PD patients.
Measured: 12 months
Changes in the Hamilton Depression-17 (HAMD-17) Scale scores
The HAMD-17 Scale is the most widely used scale in clinical evaluation of depression in PD patients. This project takes 8 points as the critical value of depression, and the total score over 35 points is considered as severe depression, more than 20 points is likely to be diagnosed with depression, less than 8 points is not depressed.
Measured: 12 months
Change from baseline in the Parkinson's Disease Sleep Scale (PDSS) scores
The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1), sleep onset and maintenance insomnia (items 2 and 3), nocturnal restlessness (items 4 and 5), nocturnal psychosis (items 6 and 7), nocturia (items 8 and 9), nocturnal motor symptoms (items 10-13), sleep refreshment (item 14) and daytime dozing (item 15). Scores range from 0 (poorly or often) to 10 (very good or never), with a total score of <90 indicating sleep disturbance, with higher scores indicating better sleep quality.
Measured: 12 months
Changes from baseline in the Hoehn and Yahr scale (H-Y)
The 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: 12 months
Changes from baseline in the Mini-Mental State Examination (MMSE)
The total score of tne MMSE ranges from 0 to 30, with a higher score indicating better function for Cognitive assessment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Principal investigator, Jingwen WU, Shanghai East Hospital
- Investigators
- Jingwen Wu, M.D., Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691114
- Sponsor's protocol ID
- SA-HAES-102
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 17 Feb 2023
- 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 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05691114
- Acronym / sponsor ID
- SA-HAES-102
- Conditions
- Idiopathic Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Jan 2023 (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 single-center, single-arm, dose escalation study, to explore the safety, tolerability and efficacy of human amniotic epithelial stem cells (hAESCs) for idiopathic Parkinson's disease (PD).
Detailed description
hAESCs will be administration through the Ommaya reservoir implanted into the lateral ventricle of subjects with idiopathic PD.
This dose escalation will be followed by an exploratory expansion phase in 3 cohorts.
- Dose A (5×10^7 cells/dose)
- Dose B (1.0×10^8 cells/dose)
- Dose C (1.5×10^8 cells/dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hAESCs treatment | Experimental | Biological: hAESCshAESCs will be administration through Ommaya reservoir implanted into the lateral ventricle. The tolerability, safety, and efficacy will be examined of 4 monthly doses of hAESCs for 3 months followed by 2 doses every 3 months in dose escalation through 3 cohorts. * Dose A (5×10^7 cells/dose) * Dose B (1.0×10^8 cells/dose) * Dose C (1.5×10^8 cells/dose). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 40-70 years old, with more than 5 years of idiopathic PD history
- UPDRS-III off-time scores ≤49
- MMSE scores ≥24
- HAMD-17 scores < 25
- H-Y on-time scores ≤4
Key exclusion criteria (19 listed)
- secondary PD or Parkinson's syndrome
- subcutaneous apomorphine treatment
- scoring ≥ 2 on UPDRS-I item 2, or ≥ 2 on UPDRS-II item 13; or ≥ 3 on UPDRS-II item14
- history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consent
- history of seizures or prophylactic application of antiepileptic drugs
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 |
|---|---|---|
| hAESCshuman Amniotic Epithelial Stem Cells | Biological | hAESCs treatment |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 12 months
The occurrence of DLT.
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest (AESI)
Time frame: 12 Months
According to CTCAE V5.0, AE, SAE and AESI evaluated by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions. AESI is defined as intracranial infection, hemorrhage, rejection, edema, as well as acute allergic reactions and ectopic mass formation associated with the therapy.
9 secondary outcomes
Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores
Time frame: 12 months
Change from baseline in the UPDRS off-time total scores
Time frame: 12 months
Change from baseline in the UPDRS on-time total scores
Time frame: 12 months
Change from baseline in sum of the UPDRS-II and UPDRS-III scores
Time frame: 12 months
Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores
Time frame: 12 months
Changes in the Hamilton Depression-17 (HAMD-17) Scale scores
Time frame: 12 months
Change from baseline in the Parkinson's Disease Sleep Scale (PDSS) scores
Time frame: 12 months
Changes from baseline in the Hoehn and Yahr scale (H-Y)
Time frame: 12 months
Changes from baseline in the Mini-Mental State Examination (MMSE)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- 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. This study is not recruiting at the moment.
Jingwen Wu, M.D. principal investigator
Shanghai East 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 hAESCs in people with Idiopathic Parkinson's Disease, run by Shanghai East Hospital 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 10 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Wu, M.D. (021-38804518, wujingwendongfang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 12 months). 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 17 Feb 2023.