Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Joshua M Hare
With
National Heart, Lung, and Blood Institute (NHLBI)
Age
21–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.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.
Clareo Health | Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
