The intent of this clinical study is to answer the questions:
1. Is the proposed treatment safe
2. Is treatment effective in improving the disease pathology of patients after Stroke and
Procedure: Harvesting and Isolation of Stem Cells
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01453829
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01453829
Tijuana, Baja California, Mexico, 22010
View full eligibility
Tris trial is registered with FDA with number: NCT01453829. The sponsor of the trial is Ageless Regenerative Institute and it is looking for 0 volunteers for the current phase.
Official trial title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Internal Carotid Artery and Intravenously in Patients After Stroke
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