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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:
Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting and Isolation of Stem Cells | Procedure | This will be an open-label, non-randomized multi-center patient sponsored study of 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 implanted into the Internal Carotid Artery and intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months | 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. | 1 week |
| Number of participants with adverse events at 2 weeks | two weeks | |
| Number of participants with adverse events at 4 weeks | 4 weeks | |
| Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months | 6 months | |
| Number of participants with adverse events at 3 weeks | 3 weeks | |
| Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months | 3 months | |
| Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months | 3 months |
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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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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months | 3 months |
| Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months | 6 months |
| Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months | 6 months |
| Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months | 6 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |