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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ACESO-IHD Trial 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.Check my eligibility
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.See study design
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.
ACESO-IHD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have type 2 diabetes with an HbA1C over 7% or I am on medication for it.
Select...
I have heart disease symptoms and need a heart vessel check.
Select...
I have heart disease symptoms and need a heart vessel check.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
ACESO-IHD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-PCI coronary artery endothelial function as assessed via FFR
Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR
Secondary outcome measures
Circulating angiogenic factors marker levels
Circulating inflammatory markers
EPC-CFUs levels
+13 moreSide effects data
From 2020 Phase 1 & 2 trial • 16 Patients • NCT0288688433%
Allergic Reaction to Flu shot
33%
Viral Illness
33%
Hypercalcemia
33%
Bullous Pemphigoid
33%
Chest Pain
33%
Abnormal Urinalysis
33%
Proteinurea
33%
Adenocarcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pilot Phase 100 Million hMSCs
Randomized Phase 100 Million Allogeneic hMSCs
Randomized Phase 20 Million Allogeneic hMSCs
Pilot Phase 20 Million Allogeneic hMSCs
ACESO-IHD 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
902 Previous Clinical Trials
409,986 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
595 Patients Enrolled for Coronary Artery Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,564 Total Patients Enrolled
165 Trials studying Coronary Artery Disease
269,002 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I need surgery or a procedure for heart valve disease.I have type 2 diabetes with an HbA1C over 7% or I am on medication for it.You have had issues with using drugs or drinking too much alcohol in the last two years.I have heart disease symptoms and need a heart vessel check.I have been cancer-free for 5 years, except for certain skin or cervical cancers.You have HIV, hepatitis B, or active hepatitis C in your blood.My liver tests are more than three times the normal limit.I am allergic to specific heart medications, metals, plastics, or contrast dyes.My heart's arteries have narrowed again or are heavily calcified.I have received an organ transplant or had a transplant rejection.I am under 18 years old.My blood sugar has been high, with A1C over 8.5% in the last 3 months.I have heart disease symptoms and need a heart vessel check.My kidney function is low, with a GFR under 30 ml/min.I have had severe eye or nerve issues needing treatment.I am 18 years old or older.I have had a heart attack and underwent a procedure to improve blood flow to my heart.I have a bleeding disorder or take blood thinners that can't be stopped, and I refuse blood transfusions.You will be asked to provide written informed consentI am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Placebo Group
- Group 2: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies in this research endeavor?
"Affirmative. Based on information available from clinicaltrials.gov, this trial is actively recruiting participants for the study which was first posted in August 2021 and most recently updated July 2022. The recruitment includes 30 patients at a single site."
Answered by AI
What outcomes does this research endeavor hope to accomplish?
"The primary aim of this clinical trial, measured over a period of 6 months post-PCI, is to assess coronary artery endothelial function via CFR. The secondary objectives consist of Target lesion lumen loss (measured using QCA), EQ-5D Quality of Life Questionnaire Overall Health Status question (scored 0-100 with higher scores indicating better quality of life) and Seattle Angina Questionnaire (SAQ) Angina Frequency score (0-100 with the higher scores implying less physical limitations, anginal symptoms frequency and improved overall health)."
Answered by AI
How many participants are permitted to partake in this research endeavor?
"Affirmative. Clinicaltrials.gov's records show that recruitment is still underway for this medical trial, which was initially posted on August 16th 2021 and last edited on July 7th 2022. 30 people are being sought out from a single research centre to participate in the study."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Maryland
How old are they?
65+
18 - 65
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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