Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hemorrhagic Stroke
- Sponsor
- Mayo Clinic
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Occurrence of adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Abba C. Zubair, M.D., Ph.D.
medical Director
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Occurrence of adverse events
Time Frame: 1 year
Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.
Secondary Outcomes
- Changes in neurological function test(Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180)