An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously and Intranasally in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- UPDRS- Improvement in motor Examination
研究概览
简要总结
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes.
详细描述
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the Vertebral Artery and intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between Age 18 and 80 years.
- •Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.
- •Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.
- •PD of Stage 2.5, 3 & 4 of HOEHN & YAHR staging.
- •Stable Parkinsonian medications for the 60 days prior to the surgical therapy.
- •MRI not showing gross atrophy or any other pathology of brain.
- •Patients with score less than 19 for the Montgomery-Asberg Rating Scale (MADRS) for Depression.
- •NO Significant cognitive impairment.MMSE >
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society
排除标准
- •History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
- •History of psychiatric disorders like schizophrenia or psychotic disorders.
- •History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
- •Contraindication for MRI
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgement, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Systolic blood pressure (supine) ≤90 mmHg;
- •Resting heart rate > 100 bpm;
- •Active clinical infection being treated by antibiotics within one week of enrollment.
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
- •Unwilling and/or not able to give written informed consent.
研究组 & 干预措施
Intravenous Injection and Intanasal infusion of AD-SVF
AD-SVF
干预措施: Harvesting and Implantation of Adipose-Derived Stem Cells (Procedure)
结局指标
主要结局
UPDRS- Improvement in motor Examination
时间窗: 6 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
时间窗: 6 months
Number of participants with adverse events
时间窗: 4 weeks
UPDRS- Improvement in Activities of Daily Living
时间窗: 6 months
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior
时间窗: 6 months
Improvement in Mentation, Behavior and mood in on and off position
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior
时间窗: 3 months
Improvement in Mentation, Behavior and mood in on and off position
UPDRS- MODIFIED HOEHN AND YAHR STAGING
时间窗: 6 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
时间窗: 3 months
Number of participants with adverse events
时间窗: 2 weeks
Number of participants with adverse events
时间窗: 1 week
UPDRS- Improvement in Activities of Daily Living
时间窗: 3 months
UPDRS- Improvement in motor Examination
时间窗: 3 months
Values compared to baseline
UPDRS- MODIFIED HOEHN AND YAHR STAGING
时间窗: 3 months
Compared to baseline
次要结局
- Reduction of Parkinson's medications(6 months)
- Improvement in subjective symptoms: facial expression, gait, and freezing(6 months)
- Reduction of Parkinson's medications(3 months)
- Improvement in subjective symptoms: facial expression, gait, and freezing(3 months)