Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - 90
Updated:9/27/2018
Start Date:October 20, 2017
End Date:September 2024
Contact:Ivonne Schulman, MD
Email:ISchulman@med.miami.edu
Phone:305-243-3583

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A Phase I/II, Randomized, Double Blind, Pilot Trial to Evaluate the Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects

This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via
infusion therapy for diabetic subjects with endothelial dysfunction.

Sixteen (16) diabetic subject with endothelial dysfunction will be scheduled to undergo a
peripheral intravenous infusion after meeting all inclusion/exclusion criteria at baseline.

Eight (8) subjects will be treated with 20 million (2 x 10^7) allogeneic hMSC's and eight (8)
subjects will be treated with 100 million (100 x 10^6) allogeneic hMSC's

Follow up: Subjects will be followed at 3, 7, 14, 28 days, and 3 month post-infusion to
complete all safety and efficacy assessments and at 6 and 12 months post-infusion to complete
safety assessments.

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 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.
We found this trial at
1
site
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Phone: 305-243-7444
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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