An Early Phase 1 interventional study of hAESCs treatment and placebo (saline) in Parkinson's Disease, sponsored by Shanghai East Hospital. Status unknown at 1 site in China. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Shanghai East Hospital · Early Phase 1, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Shanghai East Hospital is the lead sponsor of 92 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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.
Biological: hAESCs treatment
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.
Biological: placebo (saline)
Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.
2 times placebo (normal saline) injections as control group
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.
Time frame: 12 Months
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
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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).
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)
Changes of cranial expression of dopamine transporter investigated by PET-MR
Time frame: 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
Time frame: 4 month, 6 month, 12 month
Plan to share: No
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Shanghai East Hospital