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| Name | Class |
|---|---|
| Instituto de Medicina Regenerativa | INDUSTRY |
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The intent of this clinical study is to answer the questions:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| harvesting and implantation of adipose derived stem cells | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor D Morales, MD | Instituto de Medicina Regenerativa | Principal Investigator |
| Clemente Zuñiga, md | Instituto de Medicina Regenerativa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Angeles | Tijuana | Estado de Baja California | 22010 | Mexico |
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| 6 months |
| number of brain lesions by MRI compared to baseline | 6 months |