Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (ACESO-IHD)

  • STATUS
    Recruiting
  • End date
    Jul 16, 2024
  • participants needed
    30
  • sponsor
    Joshua M Hare
Updated on 26 July 2022
diabetes
angiography
stenosis
coronary artery disease
medical therapy
ejection fraction
hba1c
heart disease
myocardial infarction
infarct
exercise stress test
hemoglobin a1c
stress test

Summary

The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Details
Condition Diabetes Mellitus, Ischemic Heart Disease
Treatment Placebo, 100 million Allogeneic Mesenchymal Human Stem Cells
Clinical Study IdentifierNCT04776239
SponsorJoshua M Hare
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be ≥ 18 years of age (males and females)
Provide written informed consent
Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography
Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) > 7%, or on medical therapy for diabetes

Exclusion Criteria

Be younger than 18 years of age
Have history of prior myocardial Infarction and revascularization
Have a baseline glomerular filtration rate (GFR) <30 ml/min 1.73m2 estimated using the Modification of Diet for Renal Disease (MDRD) formula
Have poorly controlled blood glucose levels with hemoglobin A1C > 8.5% in the previous 3 months
Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment
Have an indication for standard-of-care surgical (including valve surgery, placement of left-ventricular assist device) or percutaneous intervention for the treatment of valvular heart disease (including valvuloplasty)
Have known hypersensitivity or contraindication to aspirin; both heparin and bivalirudin; all available P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor); or any zotarolimus, cobalt, chromium, nickel, tungsten, acrylic, or fluoropolymers; or hypersensitivity to contrast media that cannot be adequately premedicated
Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/microliter (uL) or platelet values < 100,000/uL without another explanation (per investigator discretion)
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
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 serum positive for HIV, hepatitis B surface antigen (sAg), 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 and not on contraceptive medications. (May participate if on 2 forms of contraceptives)
Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up
Coronary lesions with restenosis or heavy calcification
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note