Stem Cell Injection in Cancer Survivors

Inclusion Criteria

To participate, a subject MUST:

• Be ≥ 18 and 8.5%)
• An underlying autoimmune disorder or current immunosuppressive therapy (e.g., chronic corticosteroid, rheumatologic or immune modulating therapy) or likelihood of use of immunosuppressive therapy during participation in the trial (medications will be considered on a case by case basis)
• A baseline eGFR 1.5) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors) (see Section 6.4 re: injection procedure and anticoagulation therapy) Note: Subjects who cannot be withdrawn from anticoagulation will be excluded.
• Presence of LV thrombus
• Presence of a pacemaker and/or 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
• 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 < 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
• A history of drug abuse (use of 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 24 months
• Cognitive or language barriers that prohibit obtaining informed consent or any study elements (interpreter permitted)
• Participation (currently or within the previous 30 days) in a cardiac related investigational therapeutic (including stem cell based therapies) or device trial
• Pregnancy, lactation, plans to become pregnant in the next 12 months, or is unwilling to use acceptable forms of birth control during study participation
• Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up