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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01453803
• Other study ID #: AD-US-PK-001
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2011
• Last updated: November 21, 2017
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior	Improvement in Mentation, Behavior and mood in on and off position	3 months
Primary	Number of participants with adverse events		1 week
Primary	UPDRS- Improvement in Activities of Daily Living		3 months
Primary	UPDRS- Improvement in motor Examination	Values compared to baseline	3 months
Primary	UPDRS- MODIFIED HOEHN AND YAHR STAGING	Compared to baseline	3 months
Primary	UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE		3 months
Primary	UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior	Improvement in Mentation, Behavior and mood in on and off position	6 months
Primary	Number of participants with adverse events		2 weeks
Primary	Number of participants with adverse events		4 weeks
Primary	UPDRS- Improvement in Activities of Daily Living		6 months
Primary	UPDRS- Improvement in motor Examination		6 months
Primary	UPDRS- MODIFIED HOEHN AND YAHR STAGING		6 months
Primary	UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE		6 months
Secondary	Reduction of Parkinson's medications		3 months
Secondary	Improvement in subjective symptoms: facial expression, gait, and freezing		3 months
Secondary	Reduction of Parkinson's medications		6 months
Secondary	Improvement in subjective symptoms: facial expression, gait, and freezing		6 months