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

This study is currently recruiting participants.
Verified October 2013 by Ageless Regenerative Institute
Sponsor:
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01453803
First received: October 3, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Parkinson's Disease
Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Vertebral Artery and Intravenously in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in Mentation, Behavior and mood in on and off position

  • Number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • UPDRS- Improvement in Activities of Daily Living [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • UPDRS- Improvement in motor Examination [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Values compared to baseline

  • UPDRS- MODIFIED HOEHN AND YAHR STAGING [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compared to baseline

  • UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in Mentation, Behavior and mood in on and off position

  • Number of participants with adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • UPDRS- Improvement in Activities of Daily Living [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • UPDRS- Improvement in motor Examination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • UPDRS- MODIFIED HOEHN AND YAHR STAGING [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of Parkinson's medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in subjective symptoms: facial expression, gait, and freezing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Reduction of Parkinson's medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in subjective symptoms: facial expression, gait, and freezing [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453803

Contacts
Contact: Kristin Comella 813 390 9874 kcomella@agelessregen.com

Locations
Mexico
Hospital Angeles Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Jesus A Perez, MD       jesus.perez.md@gmail.com   
Contact: Javier Lopez, MD         
Principal Investigator: Victor D Morales, MD         
Principal Investigator: Clemente Zuñiga, MD         
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Investigators
Principal Investigator: Victor D Morales, MD Instituto de Medicina Regenerativa
Principal Investigator: Clemente Zuñiga, MD Instituto de Medicina Regenerativa
  More Information

No publications provided

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01453803     History of Changes
Other Study ID Numbers: ADI-ME-PK-001
Study First Received: October 3, 2011
Last Updated: October 28, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Ageless Regenerative Institute:
Liposuction
ADSC
ASC
stem cell
Parkinson's Disease
Parkinson's
therapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 16, 2014