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Status:

RECRUITING

Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy

Lead Sponsor:

Roberto Bolli

Collaborating Sponsors:

University of Miami

University of Texas

Conditions:

Ischemic Heart Disease

Eligibility:

All Genders

21-85 years

Phase:

PHASE2

Brief Summary

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 MS...

Detailed Description

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 MS...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 4 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06145035

Start Date

March 4 2024

End Date

January 1 2026

Last Update

October 26 2024

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

2

University of Louisville School of Medicine, Institute of Molecular Cardiology

Louisville, Kentucky, United States, 40202

3

The Texas Heart Institute Houston Texas

Houston, Texas, United States, 77030