Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
- Conditions
- Hemorrhagic StrokeIntracerebral Hemorrhage
- Registration Number
- NCT03371329
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Occurrence of adverse events 1 year Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.
- Secondary Outcome Measures
Name Time Method Changes in neurological function test Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180 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.
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Florida🇺🇸Jacksonville, Florida, United States