Is NCT06145035 recruiting in Houston, TX?

Yes, NCT06145035 is currently recruiting participants at its Houston, TX location. This ischemic heart disease clinical trial is actively enrolling qualified participants.

How do I join the ischemic heart disease clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ischemic Heart Disease Clinical Trial in Houston, TX

About This Ischemic Heart Disease Study in Houston

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), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).

Sponsor: Roberto Bolli

Who Can Participate

Inclusion 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, maximally tolerated doses for ≥ 1 month prior to consent. "Stable" is defined as stable dose with no changes for 30 days after last dose adjustment. For beta blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.

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

Exclusion Criteria

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 coronary intervention (PCI) for the treatment of ischemic and/or valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 3 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS 1A or 1B, and they must have documented a low probability of being transplanted.

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., subjects 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 documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 12 months.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06145035) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Ischemic Heart Disease Treatment Options in Houston, TX

If you're searching for ischemic heart disease treatment options in Houston, TX, this clinical trial (NCT06145035) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced ischemic heart disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ischemic heart disease clinical trials near you to find additional studies recruiting in your area.

Ischemic Heart Disease Clinical Trial in Houston, TX

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