allogeneic mesenchymal human stem cells infusion therapy for endothelial dysfunction in diabetic subjects

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 16 subject trial to demonstrate the safety of allogeneic hmscs administered via infusion therapy for diabetic subjects with endothelial dysfunction.


Eligibility criteria:
inclusion criteria: * be ≥ 21 and \< 90 (inclusive) years of age. * provide written informed consent. * have endothelial dysfunction defined by impaired flow-mediated vasodilation (fmd \<7%). * have an ejection fraction \> 45% by gated blood pool scan, two- dimensional echocardiogram, cardiac mri, cardiac ct or left ventriculogram within the prior 3 months. * have diabetes mellitus type 2 documented by hemoglobin adult type 1 component (a1c) \> 7% or on medical therapy for diabetes. * females of childbearing potential must use two forms of birth control for the duration of the study. female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion. exclusion criteria: in order to participate in this study, a subject must not: * be younger than 21 years or older than 90 years of age. * have a baseline glomerular filtration rate \<35 ml/min 1.73m\^2 estimated using the modification of diet in renal disease (mdrd) formula. * have an ejection fraction \<45% by gated blood pool scan, two-dimensional echocardiogram, cardiac mri, cardiac ct or left ventriculogram within the past year, as documented by medical history. * have poorly controlled blood glucose levels with hemoglobin a1c \> 8.5%. * have a history of proliferative retinopathy or severe neuropathy requiring medical treatment. * have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation. * have liver dysfunction, as evidenced by enzymes (ast and alt) greater than three times the upper limit of normal. * have a bleeding diathesis or coagulopathy (inr \> 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions. * have lymphadenectomy or lymph node dissection in the right arm. * be an organ transplant recipient or have a history of organ or cell transplant rejection. * have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively- treated basal cell or squamous cell carcinoma, or cervical carcinoma. * have a condition that limits lifespan to \< 1 year. * have a history of drug or alcohol abuse within the past 24 months. * be on chronic therapy with immunosuppressant medication, such as corticosteroids or tumor necrosis factor - alpha (tnfα) antagonists. * be serum positive for hiv, syphilis - vdrl (confirmation with fta-abs if needed (syphilis)), hepatitis b surface antigen or viremic hepatitis c. * be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial. * be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. * any other condition that in the judgment of the investigator would be a contraindication to enrollment or follow-up.

Keywords: diabetes endothelial dysfunction stem cells