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 with Renal Failure
and clinical outcomes
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 NCT01453816
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.
Chronic Kidney Disease(CKD) patients of stage III, IV, or V
Patient should be afebrile 24 hours prior to procedure.
Up to date on all age and gender appropriate cancer screening per American Cancer Society.
Acute Renal Failure
Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
Hemoglobin level below 6g/dl or at the discretion of the physician depending on patient's overall condition.
Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
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. Patients known to have tested positive for Human immunodeficiency virus (HIV), Human T-lymphotropic virus(HTLV), Hepatitis B
(HBV),Hepatitis C (HCV), Cytomegalovirus (CMV) and/or syphilis will be evaluated by an expert as to patient 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 200mmHg
Resting heart rate > 100 bpm;
Active clinical infection 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 NCT01453816
Tijuana, Baja California, Mexico, 22010
View full eligibility
Tris trial is registered with FDA with number: NCT01453816. 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 Renal Artery and Intravenously in Patients With Renal Failure
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