Parkinson's DiseaseEarly Phase 1NCT05435755
Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.
A Early Phase 1 study testing hAESCs treatment in people with Parkinson's Disease, run by Shanghai East Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- hAESCs treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2022to 30 Aug 2023
- Phase
- Early 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-70 years old, with more than 5 years primary Parkinson's disease history, male or female;
- The "off-age" UPDRS exercise score is between 38 and 70 points, two times before the operation, the "down period" UPDRS exercise score was stable, that is, (high value - low value) / high value ≤ 10%;
- The Parkinson treatment is stable for more than 3 months;
- Levodopa treatment was effective;
- No general anesthesia contraindications, no contraindications to stereotactic surgery and other conditions that interfere with clinical evaluation;
- No abnormalities affecting cell transplantation were found through the cranial MRI;
- Patients shall be properly cared during treatment, and caregivers can provide transplantation situations and assistance to the researcher if necessary.
Who cannot join
- Atypical Parkinson's disease, such as Parkinson's syndrome, secondary Parkinson's disease;
- Only having tremor syndrome;
- "off period" or "on period" has serious movement disorders and cannot complete any routine exercise tasks;
- Symptoms of severe neurological deficits caused by other diseases;
- Severe mental symptoms or dementia;
- Patients are unwilling to cooperate or incapable of completing self-evaluation, and cannot complete the evaluator with the help of a doctor;
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- History of striatum or extrapyramidal surgery, including deep brain stimulation (DBS);
- Injecting apomorphine treatment;
- Abnormal blood coagulation or ongoing anticoagulation therapy;
- Women of childbearing age who do not take effective contraception;
- Pregnant or lactation;
- Patients who have participated in other clinical studies of drugs or medical devices within 3 months;
- Botox toxin, phenol, subarachnoid injection of baclofen or interventional therapy for the treatment of dystonia or spasticity within 6 months;
- History of seizures or prophylactic anti-epileptic drugs;
- Alcohol or drug abuse;
- Severe cognitive impairment, depression, or behavioral disorder, defined as the Mini-Mental State Assessment Scale (MMSE) of less than 26 points, and the Hamilton Depression Rating Scale (HAMD) of greater than 35 points;
- Malignant tumor or active infection within 5 years;
- Serum virology showed positive results for hepatitis C virus (HCV) , treponema pallidum (TP) or HIV; Active hepatitis B (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive, and peripheral blood HBV DNA titer ≥1×10^3 IU/ mL);
- Abnormal liver and kidney function tests in the laboratory, liver and kidney function is defined as Alanine aminotransferase（ALT), Aspartate aminotransferase（AST) is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) and Creatinine（Cr) are less than the upper limit of normal.
- Other conditions considered ineligible for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Jingwen Wu
Shanghai, Shanghai Municipality, 200000
Jingwen Wu, Dr, 18916111526, wujingwendongfang@163.com
About this study
Official title: The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease.
The purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD.
Read the detailed description
The study plans to use randomized controlled trial and recruit 12 participants with Idiopathic Parkinson's disease. The trial will be divided into two groups, hAESCs treatment group and control group, each group 6 subjects. Through surgical robot technology, hAESCs will be precisely multiple transplanted into the lateral ventricles, that is two times consolidation hAESCs treatments or placebo were added to the four times basic hAESCs treatments. Therapeutic safety and effectiveness of multiple treatments of hAESCs on PD will be evaluated to further develop the optimal stem cell treatment strategy.
- Conditions
- Parkinson's Disease
- Being tested
- hAESCs treatment, placebo (saline)
- Keywords
- Parkinson's Disease; stem cell
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAESCs treatmentBiological
Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.
placebo (saline)Biological
2 times placebo (normal saline) injections as control group
| Study group | Role | What they receive |
|---|---|---|
| hAESCs treatment | Experimental | A total of 6 times hAESCs transplants will be performed. 50 million (in 2ml) hAESCs will be transplanted into the ventricle of participants through the Ommaya sac (set as day 0 at the beginning of the trial). Subsequently, hAESCs ventricle transplants will be performed at 1 month ±5 days, 2 months ±5 days, 3 months ±5 days, 6 months ±5 days, and 9 months ±5 days after the first cell transplantation, with a volume of 50 million cells (in 2 ml) each time. Receives: Biological: hAESCs treatment |
| Control group | Placebo comparator | Four times hAESCs transplants and two times placebo (cell preservation solution) injections will be performed by Ommaya sac. 50 million (in 2ml) hAESCs will be transplanted into the ventricle of participants (set as day 0 at the beginning of the trial). Subsequently, hAESCs will be transplanted into the ventricle for 3 times, respectively, at 1 month ±5 days , 2 months±5 days , and 3 months ±5 days after the first cell transplantation, with a volume of 50 million cells (in 2 ml) each time. Ventricle injection of 2 ml placebo (cell preservation solution) will be performed at 6 months ±5 days and 9 months ±5 days after the first cell transplantation. Receives: Biological: placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest(AESI)
AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after Ommaya sac installation by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study.
AESI is defined as intracranial infection, hemorrhage, rejection, and edema within 7 days after Ommaya sac installation, as well as acute allergic reactions and ectopic mass formation associated with study therapy.
Measured: 12 Months
Secondary outcomes (8)
Changes in Unified Parkinson's Disease Rating Scale (UPDRS) in OFF state between the experimental group and the control group at 12 months after the first hAESCs treatment
UPDRS is used for evaluating the impairment and disability associated with Parkinson's Disease (PD). It consists of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.
The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Measured: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
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: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Schwab and England score
The Schwab and England score develop a scale that describes the capacity of daily living shown by a PD patients. It measures the following three areas: dependence, abilities, and awareness. The Schwab and England score range from o% to 100%, with higher scores indicating greater healthy status.
Measured: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Parkinson's Disease Questionnaire (PDQ-39)
PDQ-39 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: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Hamilton Depression (HAMD) Scale
HAMD 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: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Differences in biochemical indicators of cerebrospinal fluid
Cerebrospinal fluid indicator tests include biochemical indicators and the following parameters: Dopamine (DA), high vanillic acid (HVA), 5-hydroxytryptamine (5-HT), 5-hydroxyindoleacetic acid (5-HIAA), norepinephrine (MHPG), α synuclein (α-synuclein), amyloid deposition (Aβ42), Tau protein (Tau) Protein, Neurofilament light (NF-L), and yKL-40 (YKL-40).
Measured: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Cranial dopamin transporter measured by positron emission tomography (PET)- magnetic resonance imaging (MRI)
Changes of cranial expression of dopamine transporter investigated by PET-MR
Measured: 4 month, 6 month, 12 month
Glucose metabolism measured by 18F-Fluoro-2-deoxy-glucose (FDG) PET scan
Changes of cranial glucose metabolism investigated by PET-MR
Measured: 4 month, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start2 Dec 2022 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study plans to recruit 12 patients who meet the criteria. 50 millions hAESCs will be transplanted to participants with PD.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- Sponsor
- Investigators
- Jingwen Wu, Dr, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435755
- Sponsor's protocol ID
- 2020YFA0112600
- Status last verified
- Oct 2022
- First submitted
- 15 Mar 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05435755
- Acronym / sponsor ID
- 2020YFA0112600
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease; stem cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- 2 Dec 2022 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 28 Jun 2022 (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 purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD.
Detailed description
The study plans to use randomized controlled trial and recruit 12 participants with Idiopathic Parkinson's disease. The trial will be divided into two groups, hAESCs treatment group and control group, each group 6 subjects. Through surgical robot technology, hAESCs will be precisely multiple transplanted into the lateral ventricles, that is two times consolidation hAESCs treatments or placebo were added to the four times basic hAESCs treatments. Therapeutic safety and effectiveness of multiple treatments of hAESCs on PD will be evaluated to further develop the optimal stem cell treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study plans to recruit 12 patients who meet the criteria. 50 millions hAESCs will be transplanted to participants with PD.
| Arm | Type | Receives |
|---|---|---|
| hAESCs treatment | Experimental | Biological: hAESCs treatmentA total of 6 times hAESCs transplants will be performed. 50 million (in 2ml) hAESCs will be transplanted into the ventricle of participants through the Ommaya sac (set as day 0 at the beginning of the trial). Subsequently, hAESCs ventricle transplants will be performed at 1 month ±5 days, 2 months ±5 days, 3 months ±5 days, 6 months ±5 days, and 9 months ±5 days after the first cell transplantation, with a volume of 50 million cells (in 2 ml) each time. |
| Control group | Placebo comparator | Biological: placebo (saline)Four times hAESCs transplants and two times placebo (cell preservation solution) injections will be performed by Ommaya sac. 50 million (in 2ml) hAESCs will be transplanted into the ventricle of participants (set as day 0 at the beginning of the trial). Subsequently, hAESCs will be transplanted into the ventricle for 3 times, respectively, at 1 month ±5 days , 2 months±5 days , and 3 months ±5 days after the first cell transplantation, with a volume of 50 million cells (in 2 ml) each time. Ventricle injection of 2 ml placebo (cell preservation solution) will be performed at 6 months ±5 days and 9 months ±5 days after the first cell transplantation. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 30-70 years old, with more than 5 years primary Parkinson's disease history, male or female;
- The "off-age" UPDRS exercise score is between 38 and 70 points, two times before the operation, the "down period" UPDRS exercise score was stable, that is, (high value - low value) / high value ≤ 10%;
- The Parkinson treatment is stable for more than 3 months;
- Levodopa treatment was effective;
- No general anesthesia contraindications, no contraindications to stereotactic surgery and other conditions that interfere with clinical evaluation;
Key exclusion criteria (20 listed)
- Atypical Parkinson's disease, such as Parkinson's syndrome, secondary Parkinson's disease;
- Only having tremor syndrome;
- "off period" or "on period" has serious movement disorders and cannot complete any routine exercise tasks;
- Symptoms of severe neurological deficits caused by other diseases;
- Severe mental symptoms or dementia;
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 |
|---|---|---|
| hAESCs treatmentPrecise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease. | Biological | hAESCs treatment |
| placebo (saline)2 times placebo (normal saline) injections as control group | Biological | Control group |
Primary outcome
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest(AESI)
Time frame: 12 Months
AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after Ommaya sac installation by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study. AESI is defined as intracranial infection, hemorrhage, rejection, and edema within 7 days after Ommaya sac installation, as well as acute allergic reactions and ectopic mass formation associated with study therapy.
8 secondary outcomes
Changes in Unified Parkinson's Disease Rating Scale (UPDRS) in OFF state between the experimental group and the control group at 12 months after the first hAESCs treatment
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Hoehn and Yahr scale
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Schwab and England score
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Changes in the Hamilton Depression (HAMD) Scale
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Differences in biochemical indicators of cerebrospinal fluid
Time frame: day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.
Cranial dopamin transporter measured by positron emission tomography (PET)- magnetic resonance imaging (MRI)
Time frame: 4 month, 6 month, 12 month
Glucose metabolism measured by 18F-Fluoro-2-deoxy-glucose (FDG) PET scan
Time frame: 4 month, 6 month, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- 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, Dr 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 Early Phase 1 study testing hAESCs treatment in people with 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 7 inclusion and 20 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 28 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Wu, Dr (18916111526, wujingwendongfang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest(AESI) (time frame: 12 Months). 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 28 Oct 2022.