Status:
COMPLETED
Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Lead Sponsor:
Mayo Clinic
Conditions:
Hemorrhagic Stroke
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Ther...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03371329
Start Date
December 12 2017
End Date
October 9 2020
Last Update
December 21 2020
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224