Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage

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.

- 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.