Is NCT06464588 recruiting in Atlanta, GA?

Yes, NCT06464588 is currently recruiting participants at its Atlanta, GA location. This dilated cardiomyopathy clinical trial is actively enrolling qualified participants.

How do I join the dilated cardiomyopathy clinical trial in Atlanta?

To join this clinical trial in Atlanta, 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 Atlanta 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.

Dilated Cardiomyopathy Clinical Trial in Atlanta, GA

About This Dilated Cardiomyopathy Study in Atlanta

This is a Phase 1 study to determine the safety and efficacy of allogeneic neonatal mesenchymal stromal cells (nMSCs) for the treatment of Dilated Cardiomyopathy. The purpose of the study is to help doctors and scientists learn if allogeneic neonatal mesenchymal stromal cells (nMSCs) infusions are a safe and effective way to improve cardiac function and left ventricular ejection fraction.

Sponsor: Emory University

Who Can Participate

Inclusion Criteria

Phase 1A: Age greater than or equal to 16 years and less than 40 years (≥16 years, \<40 years).

Phase 1B: Age greater than or equal to 4 years and less than 16 years (≥4 years, \<16 years)

Subjects must be able to sign their own consent for Phase 1A of the study.

Diagnosis of dilated cardiomyopathy (DCM) defined as

Any Congenital Cardiac Malformation with systemic ventricular systolic dysfunction; Idiopathic Cardiomyopathy; Familial/Inherited and/or Genetic Cardiomyopathy; History of Myocarditis; Acquired (Chemotherapy, Iatrogenic, Infection, Rheumatic, Nutritional); Ischemic (e.g. Kawasaki Disease, post-operative); Left ventricular noncompaction; Coronary Artery Disease

Left ventricular ejection fraction less than or equal to 45% documented by two-dimensional echocardiogram or cardiac MRI within the prior six months.

Left ventricular dilation as defined by echocardiography left ventricular and end-diastolic dimension Z score \> +2.0

Biventricular physiology with systemic left ventricle

Must receive guideline directed heart failure as defined by the American Heart Association, American College of Cardiology, and Heart Failure Society of America 118

Have been unresponsive or poorly responsive to at least 3 months of maximum guideline directed treatments.

Exclusion Criteria

Listed for heart transplantation (as UNOS status 1A) or hospitalized while waiting for transplant (while on inotropes or with ventricular assist device)

Cardiovascular surgery of percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 1A/1B.

Previous heart transplant recipient

Unoperated primary obstructive or severe regurgitant valve (aortic, pulmonary, mitral or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction anticipated to require surgical or transcatheter intervention within 6 months.

Restrictive or hypertrophic cardiomyopathy

Cardiogenic shock

Currently on extracorporeal membrane oxygenation support

Ventricular assist device support

Lethal, uncontrollable arrhythmia defined as an arrhythmia resulting in hemodynamic instability requiring need for defibrillation, continuous intravenous anti-arrhythmic medication or mechanical circulatory support

Patients with persistent atrial fibrillation requiring specific pharmacotherapy

Amyloidosis

Ischemic dilated cardiomyopathy

Clinical history of malignant neoplasm within 5 years (with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma)

Serious neurologic disorder including loss of vision, stroke, or paralysis

High-grade pulmonary embolism requiring interventional catheter procedure or pulmonary hypertension requiring use of pulmonary vasodilators including phosphodiesterase inhibitor or nitric oxide

High-grade renal failure \[eGFR\<45\] mL/min/1.73 m2 - serum potassium \>5.3 mmol/L

Multiple organ failure

Non-cardiac condition that limits life span for \<1 year

Uncontrolled diabetes (HbA1c \>9%) at screening

Active infection (including endocarditis) requiring pharmacotherapy

Active hemorrhagic disease (e.g., gastrointestinal bleeding, injury)

History of cardiac transplantation

Immune system-altering medications, or immunosuppressive therapy at the time of enrolment or within the prior 12 weeks

Dystrophin-associated cardiomyopathy confirmed by standard cardiomyopathy panel testing

Confirmed myocarditis at time of screening

Elevated LFTs greater than 2 times upper limit of normal at time of consent

Elevated WBC greater than upper limit of normal as defined by local lab at time of consent

Presence of HLA antibodies specific for therapeutic study product

History of noncompliance, alcohol abuse, recreational drug use, or incarceration within the last year

Currently pregnant or breastfeeding

Unsafe/unfeasible to enroll due to PI/designee discretion

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 Atlanta?

Yes, this clinical trial (NCT06464588) has an active research site in Atlanta, GA 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.

Dilated Cardiomyopathy Treatment Options in Atlanta, GA

If you're searching for dilated cardiomyopathy treatment options in Atlanta, GA, this clinical trial (NCT06464588) 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 Atlanta research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced dilated cardiomyopathy 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 dilated cardiomyopathy clinical trials near you to find additional studies recruiting in your area.

Dilated Cardiomyopathy Clinical Trial in Atlanta, GA

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