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

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2014

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • UPDRS (UNIFIED PARKINSON’S DISEASE RATING SCALE)-Behavior
    • Time Frame: 3 months
      Safety Issue?: No
  • Number of participants with adverse events
    • Time Frame: 1 week
      Safety Issue?: Yes
  • UPDRS- Improvement in Activities of Daily Living
    • Time Frame: 3 months
      Safety Issue?: No
  • UPDRS- Improvement in motor Examination
    • Time Frame: 3 months
      Safety Issue?: No
  • UPDRS- MODIFIED HOEHN AND YAHR STAGING
    • Time Frame: 3 months
      Safety Issue?: No
  • UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
    • Time Frame: 3 months
      Safety Issue?: No
  • UPDRS (UNIFIED PARKINSON’S DISEASE RATING SCALE)Behavior
    • Time Frame: 6 months
      Safety Issue?: No
  • Number of participants with adverse events
    • Time Frame: 2 weeks
      Safety Issue?: Yes
  • Number of participants with adverse events
    • Time Frame: 4 weeks
      Safety Issue?: Yes
  • UPDRS- Improvement in Activities of Daily Living
    • Time Frame: 6 months
      Safety Issue?: No
  • UPDRS- Improvement in motor Examination
    • Time Frame: 6 months
      Safety Issue?: No
  • UPDRS- MODIFIED HOEHN AND YAHR STAGING
    • Time Frame: 6 months
      Safety Issue?: No
  • UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
    • Time Frame: 6 months
      Safety Issue?: No

Secondary Measures

  • Reduction of Parkinson’s medications
    • Time Frame: 3 months
      Safety Issue?: No
  • Improvement in subjective symptoms: facial expression, gait, and freezing
    • Time Frame: 3 months
      Safety Issue?: No
  • Reduction of Parkinson’s medications
    • Time Frame: 6 months
      Safety Issue?: No
  • Improvement in subjective symptoms: facial expression, gait, and freezing
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Ageless Regenerative Institute
  • Collaborator
    • Instituto de Medicina Regenerativa, S.A. de C.V.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Victor D Morales, MD, Principal Investigator, Instituto de Medicina Regenerativa
    • Clemente Zuñiga, MD, Principal Investigator, Instituto de Medicina Regenerativa
  • Overall Contact(s)
    • Kristin Comella, 813 390 9874, kcomella@agelessregen.com

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01453803