Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.



Status:Recruiting
Conditions:Cardiology, Endocrine
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:21 - 95
Updated:2/24/2019
Start Date:April 12, 2018
End Date:June 2026
Contact:Joshua M Hare, MD
Email:jhare@med.miami.edu
Phone:305-243-5579

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A Phase I/II, Randomized, Placebo-controlled Comparative Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Bone Marrow (BM) Derived MSCs to Evaluate Cytokine Suppression in Patients With Chronic Inflammation Due to Metabolic Syndrome.

This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered
intravenously in patients to evaluate cytokine suppression in patients with chronic
inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37
patients in two phases (Pilot and Randomized).

In this Study, cells administered via intravenous infusion (IV) will be tested in 37 patients
in two phases (Pilot and Randomized):

The pilot phase will consist of 12 subjects and the randomized phase will consist of 25
subjects.

Subjects in each pilot phase group (Group 1, 2, 3 and 4) will not be treated less than 5 days
apart and will each undergo full evaluation post infusion to demonstrate there is no evidence
of treatment emergent SAE's prior to proceeding with the treatment of further subjects.

For subjects randomized to Group 3, 4, C and D (BMMSCs); the cells will be derived from a
sample of the subject's bone marrow (obtained by iliac crest aspiration) approximately 4-6
weeks prior to infusion.

Duration of Study Participation will be 12 months (Follow-up will be at 2 weeks, 1 Month, 3,
6, and 12 months.)

Inclusion Criteria:

- Provide written informed consent

- Subjects age >21(greater than or equal to 21) and < 85 (less than or equal to 85 years
at the time of signing the Informed Consent Form.

- Show signs of cytokine suppression

- Each subject must have endothelial dysfunction.

- At the time of enrollment, each subject must meet at least 3 out of the 5 criteria
under the harmonized definition of the metabolic syndrome, consisting of the
following:

- Hypertension

- Elevated triglycerides

- Reduced high-density lipoprotein (HDL) levels

- Elevated fasting glucose

- Apple shaped adiposity

Exclusion Criteria:

- Be a female who is pregnant, nursing, or of childbearing potential while not
practicing effective contraceptive methods. Female subjects must undergo a blood or
urine pregnancy test at screening and within 36 hours prior to infusion.

- Inability to perform any of the assessments required for endpoint analysis.

- Active listing (or expected future listing) for transplant of any organ.

- Clinically important abnormal screening laboratory values, as determined by the P.I.

- Serious comorbid illness or any other condition that, in the opinion of the
investigator, may compromise the safety or compliance of the subject or preclude
successful completion of the study.

- Have known allergies to penicillin or streptomycin.

- Hypersensitivity to dimethyl sulfoxide (DMSO).

- Be an organ transplant recipient.

- Have a clinical history of malignancy within 3 years (i.e., subjects with prior
malignancy must be disease free for 3 years), except curatively- treated basal cell
carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma, if
recurrence occurs.

- Have a non-pulmonary condition that limits lifespan to < 1 year.

- Have a history of drug or alcohol abuse within the past 24 months.

- Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C, and/or Syphilis -
VDRL (Confirmation with FTA-ABS if needed (Syphilis)).

- Be currently participating (or participated within the previous 30 days) in an
investigational therapeutic or device trial.

- Patients with EF<45% (heart failure patients).

- GFR < or equal to 35 (chronic kidney disease stage 3 or higher).

- Liver disease (elevated LFTs greater than 3x normal limit).

- Advanced pulmonary disease (requiring home oxygen and/or less than 1 expected life
span).

- Proliferative diabetic retinopathy

- Hemoglobin A1C greater than 7.
We found this trial at
1
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Miami, Florida 33136
Principal Investigator: Joshua M Hare, MD
Phone: 305-243-5579
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