Status:
UNKNOWN
Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.
Lead Sponsor:
Shanghai East Hospital
Collaborating Sponsors:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-70 years
Phase:
EARLY_PHASE1
Brief 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.
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,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05435755
Start Date
December 2 2022
End Date
August 30 2023
Last Update
October 28 2022
Active Locations (1)
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1
Jingwen Wu
Shanghai, Shanghai Municipality, China, 200000