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

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

The intent of this clinical study is to answer the questions:

1. Is the proposed treatment safe
2. Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson's Disease
• Intervention / Treatment: Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Aventura, Florida, United States, 33180
      • Ageless Regenerative Institute LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Injection and Intanasal infusion of AD-SVF; AD-SVF	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events		4 weeks
Number of participants with adverse events		1 week
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior	Improvement in Mentation, Behavior and mood in on and off position	3 months
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
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	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

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson's Disease; stem cell; ASC; therapy; Parkinson's; ADSC; Liposuction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: AD-US-PK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED