Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

Mayo Clinic9 enrolled

Overview

The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemorrhagic Stroke Intracerebral Hemorrhage

Interventions

MSCBIOLOGICAL

bone marrow derived cultured MSC (mesenchymal stem cell)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Occurrence of adverse events

Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year.

Time frame: 1 year

Secondary Outcomes

Changes in neurological function test

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.

Time frame: Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180

Data from ClinicalTrials.gov

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