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New treatment option for Ischemic Heart Disease
Official title Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
ClinicalTrials.gov ID: NCT06145035
What this study is testing
What is umbilical cord-derived mesenchymal stromal cells (UC-MSCs)?
umbilical cord-derived mesenchymal stromal cells (UC-MSCs) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic heart disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85
You may be able to join if
- Be ≥ 21 and ≤ 85 years of age.
- Have documented CAD (\> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.
- Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.
- Have an EF ≤ 40% by MRI.
- Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists...
You likely can't join if
- Indication for standard of care surgery (including valve surgery, placement of left ventricular assist device, or imminent heart transplantation)...
- Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
- History of ischemic or hemorrhagic stroke within 90 days of consent
- Presence of a pacemaker and/or implantable cardiac device (ICD) generator with any of the following limitations/conditions:
- manufactured before the year 2000
- leads implanted \< 6 weeks prior to consent
See the full eligibility criteria
- Be ≥ 21 and ≤ 85 years of age.
- Have documented CAD (\> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.
- Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.
- Have an EF ≤ 40% by MRI.
- Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists, hydralazine isosorbide, sodium-glucose transporter 2 inhibitors) ) at stable...
- Have NYHA class I, II or III symptoms of HF (see Appendix A)
- If a female of childbearing potential, be willing to use one form of birth control for the duration of the study and undergo a serum pregnancy test at baseline and within 36 hours prior to infusion
- Indication for standard of care surgery (including valve surgery, placement of left ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and/or percutaneous...
- Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
- History of ischemic or hemorrhagic stroke within 90 days of consent
- Presence of a pacemaker and/or implantable cardiac device (ICD) generator with any of the following limitations/conditions:
- manufactured before the year 2000
- leads implanted \< 6 weeks prior to consent
- non transvenous epicardial or abandoned leads
- subcutaneous ICDs (if not MRI compatible)
- leadless pacemakers
- any other condition that, in the judgment of device trained staff, would deem an MRI contraindicated
- Pacemaker dependence with an ICD (Note: pacemaker dependent candidates without an ICD are not excluded)
- A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent.
- Other MRI contraindications (e.g. patient body habitus incompatible with MRI)
- An appropriate ICD firing or anti tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent
- Ventricular tachycardia ≥ 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent
- Evidence of active myocarditis
- Baseline glomerular filtration rate (eGFR) \< 35 ml/min/1.73m2
- Blood glucose levels (HbA1c) \>10%
- Hematologic abnormality evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet count \< 100,000/ul
- Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the ULN.
- HIV and/or active HBV or HCV
- Known history of anaphylactic reaction to penicillin or streptomycin
- Received gene or cell based therapy from any source within the previous 12 months.
- History of malignancy within 2 years (i.e., people with prior malignancy must be disease free for 2 years), excluding basal cell carcinoma and cervical carcinoma in situ which have been definitively treated.
- Condition that limits lifespan to \< 1 year
- History of drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or...
- Participation in an investigational therapeutic or device trial within 30 days of consent
- Cognitive or language barriers that prohibit obtaining informed consent or any study elements
- Pregnancy or lactation or plans to become pregnant in the next 12 months.
- Any other condition that, in the judgment of the Investigator or Sponsor, would impair enrollment, study product administration, or follow up.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Louisville, Kentucky, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Louisville, Kentucky, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.