Stem Cell Therapy for Heart Disease in Diabetics

(ACESO-IHD Trial)

Overseen By Russell G Saltzman, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Joshua M Hare

Must not be taking: Anticoagulants, P2Y12 inhibitors

Disqualifiers: Myocardial infarction, GFR <30, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a special stem cell therapy for individuals with heart disease and type 2 diabetes. Researchers aim to determine if allogeneic mesenchymal human stem cells can repair the heart’s blood vessels more effectively than a placebo. Individuals with type 2 diabetes and heart disease, experiencing symptoms like chest pain or shortness of breath, may qualify for this study. Participants will receive either the stem cell treatment or a placebo, which has no active therapeutic effect. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using mesenchymal stem cells (MSCs) from donors is generally safe. One study found that individuals with diabetes and blood vessel function issues tolerated MSCs well, with no major safety concerns reported. These cells can improve certain heart functions without causing serious side effects.

Another study discovered that MSCs can reduce inflammation, a common issue in many diseases. This ability to lower inflammation might help prevent negative reactions in the body.

Overall, early research suggests that MSCs are safe and could benefit those with heart problems, especially individuals with diabetes. However, as this trial is in the early stages, further research is needed to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for heart disease in diabetics, which often include medications like beta-blockers, ACE inhibitors, and lifestyle changes, allogeneic mesenchymal stem cell (MSC) therapy offers a novel approach. This treatment uses stem cells derived from human donors to potentially repair and regenerate damaged heart tissue. Researchers are excited because MSCs have a unique ability to reduce inflammation and promote tissue healing, which could lead to improved heart function and outcomes for patients. Additionally, the treatment involves a single intravenous administration, which could offer a more convenient and less invasive option compared to current long-term treatment regimens.

What evidence suggests that this treatment might be an effective treatment for heart disease in diabetics?

Research has shown that Allogeneic Mesenchymal Stem Cells (MSCs) can improve heart function. Studies have found that MSC therapy enhances heart pumping ability in people with heart disease. In this trial, some participants will receive a single intravenous dose of allogeneic human Mesenchymal Stem Cells (hMSCs). For individuals with type 2 diabetes, MSCs can also help control blood sugar, lower HbA1c levels, and reduce insulin needs. These cells aid in heart repair and decrease harmful effects like cell death and scar tissue formation. Overall, MSCs hold promise for managing heart disease, especially in those with diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Nikolaos Spilias, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes and symptomatic ischemic heart disease needing coronary angiography. Participants must have an HbA1C > 7% or be on diabetes medication, but not pregnant, nursing, or without contraception if of childbearing potential. Exclusions include organ transplant recipients, certain infections like HIV/hepatitis, recent participation in other trials, severe kidney/liver/blood conditions, allergies to specific medications used in the study.

Inclusion Criteria

I have type 2 diabetes with an HbA1C over 7% or I am on medication for it.

I have heart disease symptoms and need a heart vessel check.

I have heart disease symptoms and need a heart vessel check.

Exclusion Criteria

You have low red blood cell, white blood cell, or platelet counts without a clear reason.

I am not pregnant, nursing, or if capable of becoming pregnant, I am on two forms of contraception.

You have a medical condition that is expected to shorten your life to less than one year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Allogeneic Mesenchymal Human Stem Cells

Trial Overview The ACESO-IHD trial is testing whether injecting 100 million allogeneic Mesenchymal Human Stem Cells can repair blood vessel lining better than a placebo in diabetic patients with heart issues due to blocked arteries. The stem cells are thought to help fix bone marrow cells that aid healing.

How Is the Trial Designed?

Group I: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group Experimental Treatment 1 Intervention

Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).

Group II: Group 2: Placebo Group Experimental Treatment 1 Intervention

Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.

Who Is Running the Clinical Trial?

Joshua M Hare

Lead Sponsor

Trials

17

Recruited

430+

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12131437/

Mesenchymal stem cell-based therapy for type 1 & 2 ... Mesenchymal stem cell-derived therapy is an efficacious glycemia-lowering modality agent compared to conventional therapy in T1DM and T2DM patients.

2. ahajournals.org ahajournals.org/doi/10.1161/circresaha.117.311827?doi=10.1161/CIRCRESAHA.117.311827

Dose Comparison Study of Allogeneic Mesenchymal Stem ... Allogeneic hMSCs therapy improved cardiac function in ICM patients as assessed by cardiac CT scan, with an increase in EF in the 100 million and scar size ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0040816625003234

Mesenchymal stem cell therapy for diabetes: An umbrella ... MSC therapy demonstrated significant improvements in glycemic control, particularly in T2DM, with reductions in HbA1c (up to 1.45%) and insulin requirements.

4. mdpi.com mdpi.com/2073-4409/11/2/240

Mesenchymal Stem Cell Therapy in Diabetic ... Therapy with mesenchymal stem cells has been shown to be a promising approach for the prevention of DCM because of their anti-apoptotic, anti-fibrotic and anti ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12322349/

Impact of mesenchymal stem cell therapy on cardiac function ... This meta-analysis evaluated the efficacy of mesenchymal stem cell (MSC) treatment on cardiovascular function and major adverse cardiac ...

6. ahajournals.org ahajournals.org/doi/10.1161/circ.144.suppl_1.9813

Abstract 9813: A Randomized, Double Blind, Clinical Trial ... Conclusion: Peripheral infusion of allo-MSCs for patients with DM and endothelial dysfunction is safe. Allo-MSCs improve EPCs and FMD within 14 ...

7. nature.com nature.com/articles/s41392-025-02313-9

Mesenchymal stem cells in treating human diseases MSCs have been shown to reduce the inflammatory response through various mechanisms, which causes a decrease in proinflammatory cytokines and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352320425000483

Navigating mesenchymal stem cells doses and delivery ... Moreover, allogeneic MSCs have been shown to be more effective than autologous MSCs in improving endothelial function in patients with heart diseases [40].

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04466007

NCT04466007 | Safety and Efficacy of Allogeneic Adipose ... Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia. ClinicalTrials.gov ID NCT04466007.