NCT02886884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 11, 2022

Completed
Last Updated

May 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

August 29, 2016

Results QC Date

December 8, 2021

Last Update Submit

April 18, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesEndothelial dysfunctionStem cells

Outcome Measures

Primary Outcomes (1)

  • Number of Treatment Emergent Serious Adverse Events (TE-SAEs)

    TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.

    Up to one month (post infusion)

Secondary Outcomes (6)

  • EPC-CFU Levels

    At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365

  • CRP Marker Levels

    At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365

  • Circulating Angiogenic Factor Levels

    At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365

  • Flow Mediated Diameter Percentage (FMD%)

    At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365

  • Circulating Inflammatory Marker Levels

    At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365

  • +1 more secondary outcomes

Study Arms (4)

Pilot Phase 20 million allogeneic hMSCs

EXPERIMENTAL

Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)

Drug: 20 million Allogeneic Mesenchymal Human Stem Cells

Pilot Phase 100 million hMSCs

EXPERIMENTAL

Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)

Drug: 100 million Allogeneic Mesenchymal Human Stem Cells

Randomized Phase 20 million allogeneic hMSCs

EXPERIMENTAL

Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)

Drug: 20 million Allogeneic Mesenchymal Human Stem Cells

Randomized Phase 100 million allogeneic hMSCs

EXPERIMENTAL

Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)

Drug: 100 million Allogeneic Mesenchymal Human Stem Cells

Interventions

20 million Allogeneic Mesenchymal Human Stem CellsDRUG

1 single intravenous infusion

Also known as: allo-hMSCs, stem cells
Pilot Phase 20 million allogeneic hMSCsRandomized Phase 20 million allogeneic hMSCs
100 million Allogeneic Mesenchymal Human Stem CellsDRUG

1 single intravenous infusion

Also known as: allo-hMSCs, stem cells
Pilot Phase 100 million hMSCsRandomized Phase 100 million allogeneic hMSCs

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Joshua M. Hare, MD
Organization
University of Miami
jhare@med.miami.edu
305-243-5579

Study Officials

  • Joshua M Hare, MD

    ISCI / University of Miami Miller School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Pilot phase is open label. Randomized phase is blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor - Investigator

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

October 20, 2017

Primary Completion

August 26, 2019

Study Completion

September 3, 2020

Last Updated

May 11, 2022

Results First Posted

May 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)