Brain Lesion (General)
Conditions
Keywords
diffuse brain lesion
Brief summary
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.
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.
Interventions
PROCEDUREharvesting 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.
Sponsors
Instituto de Medicina Regenerativa
Ageless Regenerative Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | up to 6 months | 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 compared to baseline | 6 months | — |
| Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline | 3 months | — |
| Improvement in standardized Gross Motor Function Measure evaluation compared to baseline | 3 months | — |
| Improved cognitive function as measured by the mini mental state exam | 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved quality of life scores compared to baseline | 3 months |
| number of brain lesions by MRI compared to baseline | 3 months |
Countries
Mexico
Outcome results
None listed