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Mesenchymal Stem Cell Therapy

Stem Cell Therapy for Heart Disease in Diabetics (ACESO-IHD Trial)

Phase 1 & 2
Recruiting
Led By Mauricio G Cohen, MD
Research Sponsored by Joshua M Hare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) > 7%, or on medical therapy for diabetes
Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography
Must not have
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 liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial will test whether stem cells can help repair heart damage in type 2 diabetics with symptomatic heart disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions at the injection site, immune response against the infused stem cells leading to inflammation or fever, and possible impacts on blood sugar control due to underlying diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes with an HbA1C over 7% or I am on medication for it.
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I have heart disease symptoms and need a heart vessel check.
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I have heart disease symptoms and need a heart vessel check.
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I am 18 years old or older.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery or a procedure for heart valve disease.
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My liver tests are more than three times the normal limit.
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I am allergic to specific heart medications, metals, plastics, or contrast dyes.
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My heart's arteries have narrowed again or are heavily calcified.
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I have received an organ transplant or had a transplant rejection.
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I am under 18 years old.
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My blood sugar has been high, with A1C over 8.5% in the last 3 months.
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My kidney function is low, with a GFR under 30 ml/min.
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I have had severe eye or nerve issues needing treatment.
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I have had a heart attack and underwent a procedure to improve blood flow to my heart.
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I have a bleeding disorder or take blood thinners that can't be stopped, and I refuse blood transfusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-PCI coronary artery endothelial function as assessed via FFR
Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR
Secondary study objectives
Circulating angiogenic factors marker levels
Circulating inflammatory markers
EPC-CFUs levels
+13 more

Side effects data

From 2020 Phase 1 & 2 trial • 16 Patients • NCT02886884
80%
Poor Diabetes Control
20%
Right Shoulder Pain
20%
Genital Herpes Simplex
20%
Gastrointestinal Stromal Tumor
20%
Abdominal Surgical Site Infection
20%
Anemia
20%
Elevated White Blood Cells with Neutrophilia
20%
Incomplete Right bundle branch block
20%
Hypoglycemia
20%
Hypokalemia
20%
Left Distal fibula fracture
20%
Proteinurea
20%
Cervical Intraepithelial Neoplasia 1, Mild Dysplasia
20%
Dry Cough
20%
Skin Irritation
20%
Urticaria
20%
Motor Vehicle Accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Phase 100 Million Allogeneic hMSCs
Pilot Phase 100 Million hMSCs
Randomized Phase 20 Million Allogeneic hMSCs
Pilot Phase 20 Million Allogeneic hMSCs

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) GroupExperimental Treatment1 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 GroupExperimental Treatment1 Intervention
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
100 million Allogeneic Mesenchymal Human Stem Cells
2017
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Joshua M HareLead Sponsor
15 Previous Clinical Trials
379 Total Patients Enrolled
University of MiamiLead Sponsor
935 Previous Clinical Trials
422,187 Total Patients Enrolled
7 Trials studying Diabetes
4,489 Patients Enrolled for Diabetes
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,177 Total Patients Enrolled
29 Trials studying Diabetes
51,820 Patients Enrolled for Diabetes

Media Library

Allogeneic Mesenchymal Human Stem Cells (Mesenchymal Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04776239 — Phase 1 & 2
Diabetes Research Study Groups: Group 2: Placebo Group, Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Diabetes Clinical Trial 2023: Allogeneic Mesenchymal Human Stem Cells Highlights & Side Effects. Trial Name: NCT04776239 — Phase 1 & 2
Allogeneic Mesenchymal Human Stem Cells (Mesenchymal Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04776239 — Phase 1 & 2
~1 spots leftby Dec 2024
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