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