Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain

This study is currently recruiting participants. (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:
NCT01453777
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 diffuse brain lesions and clinical outcomes.

Condition Intervention Phase
Brain Lesion (General)
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 Via Catheter Into the Internal Carotid Artery and Intravenously in Patients With Diffuse Lesions in the Brain

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in standardized Gross Motor Function Measure evaluation compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 6 months ] [ 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.

  • Improved cognitive function as measured by the mini mental state exam [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in standardized Gross Motor Function Measure evaluation compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improved cognitive function as measured by the mini mental state exam compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of brain lesions by MRI compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improved quality of life scores compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improved quality of life scores compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • number of brain lesions by MRI compared to baseline [ 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
    Adipose-Derived Stem cells will be derived from the patient's fat 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 internal carotid artery and intravenously.
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 internal carotid 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 Diffuse Brain Lesions with cognitive and/or functional impairment
  • MRI not showing gross atrophy or any other pathology of brain.
  • Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

  • Contraindication for MRI
  • General medical contraindications for minor surgery or angiography
  • 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 will have an expert consulted as to patient 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;
  • Resting heart rate > 100 bpm;
  • Active clinical infection 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: NCT01453777

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       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: NCT01453777     History of Changes
Other Study ID Numbers: ADI-ME-DL-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:
diffuse brain lesion

ClinicalTrials.gov processed this record on September 18, 2014