Individual Patient Expanded Access IND to Evaluate the Safety and Preliminary Efficacy of Autologous HB-adMSCs for the Treatment of Stroke

This is an Individual Patient Expanded Access IND of autologous adipose derived Mesenchymal Stem Cells with the primary goal of treating 1 individual with Stroke who has exhausted all current treatment options and whose condition has not improved. There are no FDA approved, fully restorative treatments for his condition. We propose to administer 6 autologous HB-adMSCs intravenous infusion of 200 million (2 x 10^8 cells) cells approximately every 28 days.

A protocol amendment to administer additional HB-adMSCs infusions/injections may be submitted to IRB for approval depending on the patients' response, AE/SAEs, and cell expansion characteristics.

This expanded access IND was created at the request of the subject and his physician. After receiving approvals from Western IRB and FDA, the subject will be contacted and provided with a copy of the informed consent for review. The PI will meet with the patient in person or by telephone and explain the study procedures (including the HB-adMSCs administration), and safety assessment procedures), follow-up visits, potential risks and benefits of the study, alternatives, and the voluntary nature of participation. Ample time will be given for the patient to ask questions and decide about participation. If consent is obtained, a schedule of study events and a copy of the signed informed consent document will be provided to the patient. The informed consent process will be documented in the appropriate Source Documents and will include the discussion points mentioned above.

The subject will go through a screening process that will last up to 14 days. During this time the Clinical Investigator will review labs and diagnostic test results to confirm study eligibility. Abnormal test results (i.e., ongoing infection), may require follow-up before proceeding with the treatment. This screening period will start with the "Screening Visit", which will include the following procedures:

1. Informed Consent will be obtained.
2. Demographics
3. Review of inclusion and exclusion criteria
4. Review of medical history and concomitant medications
5. Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
6. Physical exam
7. Height and weight
8. Blood samples will be collected for safety assessments: