Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Study Overview
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Brief Summary
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The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

Detailed Description
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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.

Official Title
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Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Conditions
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Hemorrhagic Stroke, Intracerebral Hemorrhage

Intervention / Treatment
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* Biological: MSC


Participation Criteria
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Eligibility Criteria
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Age range: 18 years or older Gender: Male or female Acute spontaneous supratentorial ICH documented by head CT with ICH Score between 2 - 4 inclusive Stable ICH hematoma volume 60mL or less as measured by ABC2 method by 24-72hrs Ability to be enrolled within 72 hours of onset of stroke symptoms Ability to provide written personal or surrogate consent. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR50. Subject must have adequate renal function; creatinine <1.5g/dl. Subject must be available for all specified assessments at the study site through the completion of the study. Subject must provide written ICF and authorization for use of and disclosure of PHI.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 MSC dose .5 x 10^6/kg IV<br>Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for 3 participants. | Biological: MSC<br>* bone marrow derived cultured MSC (mesenchymal stem cell)<br>|
| Experimental: Group 2 MSC dose 1 x 10^6/kg IV<br>Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10^6/kg for next 3 participants. | Biological: MSC<br>* bone marrow derived cultured MSC (mesenchymal stem cell)<br>|
| Experimental: Group 3 MSC dose 2 x 10^6/kg IV<br>Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10^6/kg for next 3 participants. | Biological: MSC<br>* bone marrow derived cultured MSC (mesenchymal stem cell)<br>|
| Experimental: Group 4 MSC dose 0.5 x 10^6/kg I<br>Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10^6/kg for final 3 participants. | Biological: MSC<br>* bone marrow derived cultured MSC (mesenchymal stem cell)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesenchymal stem cell, stroke, intracerebral hemorrhage, cell therapy