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Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients After Stroke

This study is not yet open for participant recruitment. (see Contacts and Locations)
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:
NCT01453829
First received: October 3, 2011
Last updated: March 19, 2014
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 after Stroke and clinical outcomes?

Condition Intervention Phase
Stroke
Procedure: Harvesting and Isolation of 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 Internal Carotid Artery and Intravenously in Patients After Stroke

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.

  • Number of participants with adverse events at 2 weeks [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2014
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 Isolation of Stem Cells
    This will be an open-label, non-randomized multi-center patient sponsored study of 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 implanted into the Internal Carotid Artery and intravenously.
Detailed Description:

Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

  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.
  • Symptoms and signs of clinically definite ischemic stroke or hemorrhagic stroke
  • DWI-MRI has reliably shown relevant ischemic lesions
  • Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability
  • The stroke is severe (NIH Stroke Scale >= 8 before procedure)
  • Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria:

  • 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 and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
  • Any illness which, in the Investigator's judgment, 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 or greater than 180mmHg
  • 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 five years.
  • Unwilling and/or not able to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453829

Contacts
Contact: Kristin Comella 813 390 9874 comella_5@yahoo.com

Locations
Mexico
Hospital Angeles Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Jesus Perez, MD       jesus.perez.md@gmail.com   
Contact: Javier Lopez, MD       jjlopezg@ulam.net   
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: NCT01453829     History of Changes
Other Study ID Numbers: ADI-ST-ME-001
Study First Received: October 3, 2011
Last Updated: March 19, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014