Hemorrhagic Stroke, Intracerebral Hemorrhage
Conditions
Keywords
mesenchymal stem cell, stroke, intracerebral hemorrhage, cell therapy
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.
Interventions
BIOLOGICALMSC
bone marrow derived cultured MSC (mesenchymal stem cell)
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | 1 year | Number of adverse events at each Mesenchymal Stem Cell (MSC) dose and following infusions up to one year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neurological function test | Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180 | 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. |
Countries
United States
Outcome results
None listed