Diabetes MellitusPhase 1/2ACESO-IHDNCT04776239

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

A Phase 1/2 study testing 100 million Allogeneic Mesenchymal Human Stem Cells in people with Diabetes Mellitus and Ischemic Heart Disease, run by Joshua M Hare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Ischemic Heart Disease
What is being tested?: 100 million Allogeneic Mesenchymal Human Stem Cells
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 16 Aug 2021to 26 Aug 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.

Conditions: Diabetes Mellitus, Ischemic Heart Disease
Being tested: 100 million Allogeneic Mesenchymal Human Stem Cells, Placebo
Keywords: Endothelial dysfunction, Diabetes, Stem cells
Medical subject headings: Diabetes Mellitus, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

100 million Allogeneic Mesenchymal Human Stem CellsDrug
Also called allo-human Mesenchymal Stem Cells (hMSCs), stem cells
1 single intravenous infusion
PlaceboOther
Placebo delivered via peripheral intravenous infusion

Study groups in NCT04776239
Study group	Role	What they receive
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group	Experimental	Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million). Receives: Drug: 100 million Allogeneic Mesenchymal Human Stem Cells
Group B: Placebo Group	Placebo comparator	Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Brachial Artery Flow Mediated Diameter Percentage (FMD%)
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
Measured: Baseline, Week 2, Month 1, Month 3, and Month 6
EPC-CFU Counts
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.
Measured: Baseline, Week 2, Month 1, Month 3, and Month 6

Secondary outcomes (11)

Fractional Flow Reserve (FFR)
Fractional Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
Measured: Baseline, Month 6
Coronary Flow Reserve (CFR)
Coronary Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
Measured: Baseline, Month 6
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale.
Measured: Baseline, Week 2, Month 1, Month 3, and Month 6
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale.
Measured: Baseline, Week 2, Month 1, Month 3, and Month 6
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
TE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 30 sec or with hemodynamic compromise) or atrial fibrillation at 1 month post-infusion. TE-SAEs will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event.
Measured: 1 month post infusion
Number of Participants With Major Adverse Cardiac Events (MACE)
Defined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal myocardial infarction MI at 1 year. MACE will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event.
Measured: 12 months
Number of Participants With Target Vessel Failure
Number of participants with target vessel failure will be reported. Target vessel failure is defined as any participant that encounters revascularization, death, or MI attributed to the target vessel post-PCI (percutaneous coronary intervention). The unit of measure is number of participants.
Measured: 12 months
Number of Participants With Treatment Emergent Adverse Events
The number of participants who experienced a Treatment Emergent Adverse Event (AE), as assessed by study physician, will be reported. The unit of measurement is the number of participants who experienced an event.
Measured: 12 months
Number of Participants With Abnormal Lab Values
Number of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician. The unit of measure is number of participants.
Measured: 12 months
Circulating Angiogenic Marker - VEGF
Vascular Endothelial Growth Factor (VEGF) levels from serum samples. Results are provided in units of pg/mL. Higher levels of VEGF are associated with better cardiovascular health.
Measured: Baseline, Month 1, Month 3, Month 6
Circulating Cytokine Biomarker - TNFα
Circulating Tumor necrosis factor alpha (TNFα) levels from serum samples. Results are provided in units of pg/mL. Lower values are associated with reduced inflammation.
Measured: Baseline, Month 1, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202126 Aug 2025

First posted1 Mar 2021
Study start16 Aug 2021
Primary completion30 Mar 2025
Study completion26 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04776239
Sponsor's protocol ID: 20200874
Other IDs: 1R01HL134558-01
Acronym: ACESO-IHD
Status last verified: Jun 2026
First submitted: 26 Feb 2021
Last updated: 16 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.
ClinicalTrials.gov ID: NCT04776239
Acronym / sponsor ID: ACESO-IHD / 20200874
Conditions: Diabetes Mellitus, Ischemic Heart Disease
Keywords: Endothelial dysfunction, Diabetes, Stem cells
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Joshua M HareUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 16 Aug 2021 (actual)
Primary completion: 30 Mar 2025 (actual)
Study completion: 26 Aug 2025 (actual)
First posted: 1 Mar 2021 (actual)
Results: Posted 16 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group	Experimental	Drug: 100 million Allogeneic Mesenchymal Human Stem CellsParticipants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
Group B: Placebo Group	Placebo comparator	Other: PlaceboParticipants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
100 million Allogeneic Mesenchymal Human Stem CellsAlso: allo-human Mesenchymal Stem Cells (hMSCs), stem cells1 single intravenous infusion	Drug	Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
PlaceboPlacebo delivered via peripheral intravenous infusion	Other	Group B: Placebo Group

Primary outcome

Brachial Artery Flow Mediated Diameter Percentage (FMD%)
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
EPC-CFU Counts
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.

11 secondary outcomes

Fractional Flow Reserve (FFR)
Time frame: Baseline, Month 6
Coronary Flow Reserve (CFR)
Time frame: Baseline, Month 6
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
Time frame: 1 month post infusion
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 12 months
Number of Participants With Target Vessel Failure
Time frame: 12 months
Number of Participants With Treatment Emergent Adverse Events
Time frame: 12 months
Number of Participants With Abnormal Lab Values
Time frame: 12 months
Circulating Angiogenic Marker - VEGF
Time frame: Baseline, Month 1, Month 3, Month 6
Circulating Cytokine Biomarker - TNFα
Time frame: Baseline, Month 1, Month 3, Month 6

Results and safety

Results posted to the registry on 16 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group	13	12
Group B: Placebo Group	13	12

Primary outcome: Brachial Artery Flow Mediated Diameter Percentage (FMD%)

Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6. Mean (Standard Deviation). Unit: percentage

Measure	Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group n = 13	Group B: Placebo Group n = 13
Baseline	5.80 (3.46)	4.28 (2.10)
Week 2	6.98 (3.39)	5.93 (3.13)
Month 1	7.19 (2.84)	5.64 (2.65)
Month 3	7.48 (3.59)	6.20 (2.94)
Month 6	7.2 (2.93)	5.62 (1.79)

Population analysed: Two subjects (1 in each group) were lost to follow up before completing the study.

Primary outcome: EPC-CFU Counts

Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6. Median (Inter-Quartile Range). Unit: CFUs per well

Measure	Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group n = 6	Group B: Placebo Group n = 6
Baseline	4.92 (1.42 to 7.38)	8.67 (7.33 to 12.33)
Week 2	12.16 (4.46 to 17.7)	11.67 (10.67 to 12.5)
Month 1	11.34 (4.59 to 15.75)	10.75 (5.17 to 14.83)
Month 3	7.83 (7 to 9.16)	28.5 (3.17 to 31)
Month 6	3.5 (0.33 to 12.7)	20.83 (4.33 to 33.5)

Population analysed: The number of subjects analyzed are less than the overall totals because the EPC-CFU assay protocol was altered midway through the trial; therefore, only a sub-set of subjects have complete data for this assay.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group	2 of 13 (15.4%)	11 of 13 (84.6%)	0 of 13
Group B: Placebo Group	4 of 13 (30.8%)	9 of 13 (69.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Description: Interdisciplinary Stem Cell Institute at the University of Miami Miller School websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nikolaos Spilias, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 100 million Allogeneic Mesenchymal Human Stem Cells in people with Diabetes Mellitus and Ischemic Heart Disease, run by Joshua M Hare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brachial Artery Flow Mediated Diameter Percentage (FMD%) (time frame: Baseline, Week 2, Month 1, Month 3, and Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04776239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.