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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Allogeneic Mesenchymal Human Stem Cells for heart disease in diabetics?

Research suggests that mesenchymal stem cells (a type of cell that can develop into different types of cells) have shown potential benefits in treating heart conditions and diabetic complications. They have anti-inflammatory and heart-protective properties, which may help improve heart health in diabetics. ^{1 2 3 4 5}

Is stem cell therapy safe for humans, especially for diabetics?

Research indicates that mesenchymal stem cell therapy is generally well tolerated in humans, including those with diabetes. Studies have shown that both autologous (from the same person) and allogeneic (from a donor) stem cell treatments are safe, with no major safety concerns reported in diabetic patients. ^{3 6 7 8 9}

How is the treatment with Allogeneic Mesenchymal Human Stem Cells different from other treatments for heart disease in diabetics?

This treatment uses mesenchymal stem cells, which are special cells that can transform into different types of cells and help repair damaged heart tissue. Unlike traditional treatments, these stem cells can potentially improve heart function by directly regenerating heart tissue, which is particularly beneficial for diabetics whose heart repair mechanisms are often impaired. ^{2 3 4 5 6}

Research Team

Carlos E Alfonso, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Effects of mesenchymal stromal cells on diabetic cardiomyopathy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Stable Oxidative Cytosine Modifications Accumulate in Cardiac Mesenchymal Cells From Type2 Diabetes Patients: Rescue by α-Ketoglutarate and TET-TDG Functional Reactivation. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Impaired cardioprotective function of transplantation of mesenchymal stem cells from patients with diabetes mellitus to rats with experimentally induced myocardial infarction. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperglycemia inhibits cardiac stem cell-mediated cardiac repair and angiogenic capacity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cell-based therapies for diabetic complications. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Concise review: Mesenchymal stem cell treatment of the complications of diabetes mellitus. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Type 2 diabetes mellitus duration and obesity alter the efficacy of autologously transplanted bone marrow-derived mesenchymal stem/stromal cells. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy on glycemic control and safety of mesenchymal stem cells in patients with diabetes mellitus: Systematic review and meta-analysis of RCT data. [2022]