Study to Assess the Safety and Effects of Autologous Adipose-Derived SVF Cells in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 > 21. Up to date on all age and gender appropriate cancer screening per American Cancer Society Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Injection and Intanasal infusion of AD-SVF<br>AD-SVF | Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells<br>* The adipose tissue specimen will be collected from the patient's abdomen or applicable region using a liposuction cannula. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for catheter injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior | Improvement in Mentation, Behavior and mood in on and off position | 3 months | 
| Number of participants with adverse events |  | 1 week | 
| UPDRS- Improvement in Activities of Daily Living |  | 3 months | 
| UPDRS- Improvement in motor Examination | Values compared to baseline | 3 months | 
| UPDRS- MODIFIED HOEHN AND YAHR STAGING | Compared to baseline | 3 months | 
| UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE |  | 3 months | 
| UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior | Improvement in Mentation, Behavior and mood in on and off position | 6 months | 
| Number of participants with adverse events |  | 2 weeks | 
| Number of participants with adverse events |  | 4 weeks | 
| UPDRS- Improvement in Activities of Daily Living |  | 6 months | 
| UPDRS- Improvement in motor Examination |  | 6 months | 
| UPDRS- MODIFIED HOEHN AND YAHR STAGING |  | 6 months | 
| UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Parkinson's medications |  | 3 months | 
| Improvement in subjective symptoms: facial expression, gait, and freezing |  | 3 months | 
| Reduction of Parkinson's medications |  | 6 months | 
| Improvement in subjective symptoms: facial expression, gait, and freezing |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposuction, ADSC, ASC, stem cell, Parkinson's Disease, Parkinson's, therapy