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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Brain Lesion (General)
• Intervention / Treatment: Procedure: harvesting and implantation of adipose derived stem cells

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Hospital Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline		3 months
Number of participants with adverse events	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.	up to 6 months
Improved cognitive function as measured by the mini mental state exam		3 months
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline		6 months
Improved cognitive function as measured by the mini mental state exam compared to baseline		6 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline		3 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline		6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of brain lesions by MRI compared to baseline	3 months
Improved quality of life scores compared to baseline	3 months
Improved quality of life scores compared to baseline	6 months
number of brain lesions by MRI compared to baseline	6 months

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute
• Collaborators: Instituto de Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: diffuse brain lesion
• Other Study ID Numbers: ADI-ME-DL-001