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The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.
The overall clinical development strategy of this project is to conduct this Phase I dose escalation study entitled "A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients with Recent Intracerebral Hemorrhage". This study will be performed under this current IND application and will be limited to the proposed 12 subjects (3 IV and 1 IT dose groups).
In this application the investigators are proposing to evaluate safety and feasibility of allogeneic, bone marrow (BM) derived mesenchymal stem cells (MSC) to induce neuroregeneration, improve neurological function and alleviate inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 MSC dose .5 x 10^6/kg IV | Experimental | Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants. |
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| Group 2 MSC dose 1 x 10^6/kg IV | Experimental | Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants. |
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| Group 3 MSC dose 2 x 10^6/kg IV | Experimental | Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants. |
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| Group 4 MSC dose 0.5 x 10^6/kg I | Experimental | Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC | Biological | bone marrow derived cultured MSC (mesenchymal stem cell) |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in neurological function test | The NIH Stroke Scale will be used to assess stroke-related neurologic deficits. A trained observer rates the patient's ability to perform tasks and answer questions. Ratings for each item are scored with 3 to 5 grades with 0 as normal. | Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180 |
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| Name | Affiliation | Role |
|---|---|---|
| Abba C Zubair | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38114796 | Derived | Durand NC, Kim HG, Patel VN, Turnbull MT, Siegel JL, Hodge DO, Tawk RG, Meschia JF, Freeman WD, Zubair AC. Mesenchymal Stem Cell Therapy in Acute Intracerebral Hemorrhage: A Dose-Escalation Safety and Tolerability Trial. Neurocrit Care. 2024 Aug;41(1):59-69. doi: 10.1007/s12028-023-01897-w. Epub 2023 Dec 19. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| D002543 | Cerebral Hemorrhage |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Dose escalation study
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |