NCT03371329

Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhagic Stroke
• Intracerebral Hemorrhage

Interventions

Type	Name	Description
BIOLOGICAL	MSC	bone marrow derived cultured MSC (mesenchymal stem cell)

Timeline

• Start date: 2017-12-12
• Primary completion: 2020-10-09
• Completion: 2020-10-09
• First posted: 2017-12-13
• Last updated: 2020-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study