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

Study Overview
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Brief Summary
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The intent of this clinical study is to answer the questions: Is the proposed treatment safe Is treatment effective in improving the disease pathology of patients with diffuse brain lesions and clinical outcomes.

Detailed Description
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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.

Official Title
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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

Conditions
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Brain Lesion (General)

Intervention / Treatment
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* Procedure: harvesting and implantation of adipose derived stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diffuse brain lesion