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

NCT ID: NCT03059355

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2021-02-11

Brief Summary

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).

Conditions

Endothelial Dysfunction; Metabolic Syndrome; Chronic Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pilot Phase: Group 1 (UCMSCs - 20 million)

Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.

Group Type: EXPERIMENTAL

UCMSCs

Intervention Type: BIOLOGICAL

Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)

Pilot Phase: Group 3 (UCMSCs - 100 million)

Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.

Group Type: EXPERIMENTAL

UCMSCs

Intervention Type: BIOLOGICAL

Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)

Pilot Phase: Group 2 (BMMSCs - 20 million)

Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.

Group Type: EXPERIMENTAL

BMMSCs

Intervention Type: BIOLOGICAL

Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)

Pilot Phase: Group 4 (BMMSCs -100 million)

Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.

Group Type: EXPERIMENTAL

BMMSCs

Intervention Type: BIOLOGICAL

Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)

Group A (UCMSCs - 100 million)

Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.

Group Type: EXPERIMENTAL

UCMSCs

Intervention Type: BIOLOGICAL

Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)

Group B (BMMSCs - 100 million)

Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.

Group Type: EXPERIMENTAL

BMMSCs

Intervention Type: BIOLOGICAL

Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)

Group C (Placebo)

Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

a single administration of placebo delivered via peripheral intravenous infusion.

Interventions

UCMSCs

Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)

Intervention Type: BIOLOGICAL

BMMSCs

Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)

Intervention Type: BIOLOGICAL

Placebo

a single administration of placebo delivered via peripheral intravenous infusion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent
• Subjects age > 21 and < 95 years at the time of signing the Informed Consent Form.
• Each subject must have endothelial dysfunction.

Endothelial dysfunction Criteria:

Impaired flow-mediated vasodilation (FMD <7%)

• 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:

• Waist circumference - US defined: ≥ 102 cm (males) or ≥ 88 cm (females)
• Elevated triglycerides - ≥ 150 mg/dL (1.7 mM)
• Reduced HDL-C - Males: <40 mg/dL (1.0 mM) Females: <50 mg/dL (1.3 mM)
• Elevated blood pressure - Systolic ≥ 130 mm Hg and/or Diastolic ≥ 85 mm Hg
• Elevated fasting glucose - ≥ 100 mg/dL

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 a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior enrollment) bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
• 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.
• History of drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months.
• Be serum positive for HIV, hepatitis B surface antigen or Viremic hepatitis C, and/or Syphilis.
• Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
• Patients with Ejection Fraction <45% (heart failure patients).
• Glomerular Filtration Rate < or equal to 35 (chronic kidney disease stage 3 or higher).
• Liver disease (elevated Liver Function Tests 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Marcus Foundation

OTHER

Sponsor Role: collaborator

Joshua M Hare

OTHER

Sponsor Role: lead

Responsible Party

Joshua M Hare

Director of ISCI, Louis Lemberg Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joshua M Hare, MD

Role: PRINCIPAL_INVESTIGATOR

ISCI / University of Miami Miller School of Medicine

Locations

ISCI / University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://isci.med.miami.edu

Interdisciplinary Stem Cell Institute at the University of Miami Miller School website

Other Identifiers

20170095

Identifier Type: -

Identifier Source: org_study_id