Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
NCT ID: NCT03371329
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2017-12-12
2020-10-09
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Group 1 MSC dose .5 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose .5 x 10\^6/kg for 3 participants.
MSC
bone marrow derived cultured MSC (mesenchymal stem cell)
Group 2 MSC dose 1 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 1 x 10\^6/kg for next 3 participants.
MSC
bone marrow derived cultured MSC (mesenchymal stem cell)
Group 3 MSC dose 2 x 10^6/kg IV
Intravenous infusion of MSC (mesenchymal stem cell) dose 2 x 10\^6/kg for next 3 participants.
MSC
bone marrow derived cultured MSC (mesenchymal stem cell)
Group 4 MSC dose 0.5 x 10^6/kg I
Intraventricular infusion of MSC (mesenchymal stem cell) dose .5 x 10\^6/kg for final 3 participants.
MSC
bone marrow derived cultured MSC (mesenchymal stem cell)
Interventions
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MSC
bone marrow derived cultured MSC (mesenchymal stem cell)
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Abba C. Zubair, M.D., Ph.D.
medical Director
Principal Investigators
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Abba C Zubair
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-003524
Identifier Type: -
Identifier Source: org_study_id