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| Name | Class |
|---|---|
| Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hAESCs treatment | Biological | Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingwen Wu, Dr | Contact | 18916111526 | wujingwendongfang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingwen Wu, Dr | Shanghai East Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jingwen Wu | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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The study plans to recruit 12 patients who meet the criteria. 50 millions hAESCs will be transplanted to participants with PD.
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| placebo (saline) | Biological | 2 times placebo (normal saline) injections as control group |
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| 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. | 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. | 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. | 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. | 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). | 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 | 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 | 4 month, 6 month, 12 month |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D017670 |
| Sodium Compounds |