Study to Assess the Safety and Effects of Autologous Adipose-Derived SVF Cells in Patients With Parkinson's Disease
NCT ID: NCT01453803
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-05-31
2017-12-31
Brief Summary
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1. Is the proposed treatment safe
2. Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous Injection and Intanasal infusion of AD-SVF
AD-SVF
Harvesting and Implantation of Adipose-Derived Stem Cells
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.
Interventions
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Harvesting and Implantation of Adipose-Derived Stem Cells
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Ageless Regenerative Institute
INDUSTRY
Responsible Party
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Principal Investigators
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Sharon McQuillan, MD
Role: PRINCIPAL_INVESTIGATOR
Ageless Regenerative Institute
Locations
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Ageless Regenerative Institute LLC
Aventura, Florida, United States
Countries
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Other Identifiers
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AD-US-PK-001
Identifier Type: -
Identifier Source: org_study_id