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| Name | Class |
|---|---|
| Hospitales Universitarios Virgen del RocÃo | OTHER |
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The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.
The proposed trial will involve the recruitment of a total of 20 patients.
The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.
The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bone marrow stem cells | Other | Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion on autologous CD34+ stem cells into middle cerebral artery | Procedure | Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of new neurological deficits and adverse effects during the timeframe. | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale. | Duration of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitales Universitarios Virgen del RocÃo | Seville | Andalusia | Spain | |||
| Hospital Universitario Central de Asturias |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22764211 | Derived | Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3. | |
| 22163120 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020244 | Infarction, Middle Cerebral Artery |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Oviedo |
| Principality of Asturias |
| 33006 |
| Spain |
| Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |