A Phase I First-in-Human Multicenter Randomized Double-Blinded Placebo- Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors with Anthracycline-Induced Cardiomyopathy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: cardiomyopathy
  • Age: Between 18 - 79 Years
  • Gender: Male or Female

Inclusion Criteria
Be a cancer survivor with diagnosis of AIC
Have received the initial diagnosis of AIC at least six months earlier and be on stable, optimally-tolerated therapy with beta-blockers, ACE inhibitors/ARBs, and/or aldosterone antagonists for 3 months, unless contraindicated
Have a period of at least two years of clinical cancer-free state* and low likelihood of recurrence (a five-year risk of recurrence estimated at 30% or less), as determined by an oncologist, based on tumor type, response to therapy, and negative metastatic work-up at the time of diagnosis (*exceptions to this are carcinoma in situ or fully resected basal and squamous cell cancer of the skin.)
Be a candidate for cardiac catheterization
Exclusion Criteria
A life expectancy 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 contrast allergy that cannot adequately be managed by premedication
Received gene or cell-based therapy from any source within the previous 12 months
Evidence of active systemic infection at time of study product delivery
HIV and/or active HBV or HCV
Coagulopathy (INR > 1.5) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors)
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
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 32. Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up

Recruitment Status

Open

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