Could stem cells mend broken hearts in diabetes?
NCT ID NCT04776239
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether a single infusion of donor stem cells could help repair damaged blood vessels in 26 adults with type 2 diabetes and symptomatic heart disease. Researchers measured blood vessel function and looked for signs of repair in the lab. The goal was to see if this approach is safe and might improve blood flow, not to cure the underlying conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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26 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be ≥ 18 years of age (males and females). 2. Provide written informed consent. 3. Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography. 4. Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) \> 7%, or on medical therapy for diabetes. Exclusion Criteria: 1. Be younger than 18 years of age. 2. Have history of prior myocardial Infarction and revascularization. 3. Have a baseline glomerular filtration rate (GFR) \<30 ml/min 1.73m2 estimated using the Modification of Diet for Renal Disease (MDRD) formula. 4. Have poorly controlled blood glucose levels with hemoglobin A1C \> 8.5% in the previous 3 months. 5. Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment. 6. 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). 7. 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. 8. 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). 9. Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal. 10. Have a bleeding diathesis or coagulopathy (INR \> 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions. 11. Be an organ transplant recipient or have a history of organ or cell transplant rejection. 12. 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. 13. Have a condition that limits lifespan to \< 1 year. 14. Have a history of drug or alcohol abuse within the past 24 months. 15. Be serum positive for HIV, hepatitis B surface antigen (sAg), or viremic hepatitis C. 16. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial. 17. Be pregnant, nursing, or of childbearing potential and not on contraceptive medications. (May participate if on 2 forms of contraceptives). 18. Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up. 19. Coronary lesions with restenosis or heavy calcification.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Miami
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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