Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients After Stroke


Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Males and Females between Age 18 and 80 years.
- Symptoms and signs of clinically definite ischemic stroke or hemorrhagic stroke
- DWI-MRI has reliably shown relevant ischemic lesions
- Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability
- The stroke is severe (NIH Stroke Scale >= 8 before procedure)
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria

- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg
- Resting heart rate > 100 bpm;
- Active clinical infection being treated by antibiotics within one week of enrollment.
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Unwilling and/or not able to give written informed consent.