Stem Cell Injection in Cancer Survivors

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiomyopathy Due to Anthracyclines

In brief

The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC). The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.

Key facts

Study ID

NCT02509156

Run by

The University of Texas Health Science Center, Houston

People needed

46

Starts

2016-08-01

Expected to finish

2020-04-20

Last updated by the study team

2020-11-05

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To participate, a subject MUST:
• Be ≥ 18 and < 80 years of age
• Be a cancer survivor with diagnosis of AIC
• Have an LVEF ≤ 45% by cMRI
• Be in NYHA class II-III
• 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

You may not qualify if…

• To participate, a subject MUST NOT HAVE:
• A life expectancy <12 months
• A CT scan or baseline cardiac MRI showing new tumor or suspicious lymphadenopathy raising concern of malignancy
• Presence of obstructive CAD as determined via imaging within 5 years prior to study enrollment provided there have been no symptoms or evidence of CAD since the test
• Had a previous myocardial infarction
• A history of radiation therapy AND evidence of constrictive physiology and/or evidence of other patterns of non-ischemic cardiomyopathy on cardiac MRI (e.g., amyloidosis, sarcoidosis, hemochromatosis, pure radiation-induced cardiomyopathy, etc.) not consistent with AIC being the dominant etiology of heart failure
• Valvular heart disease including 1) mechanical or bioprosthetic heart valve; or 2) severe valvular (any valve) insufficiency/regurgitation within 12 months of consent.
• Aortic stenosis with valve area ≤ 1.5cm2
• A history of LV reduction surgery or cardiomyoplasty
• Evidence of cardiogenic shock
• A history of ischemic or hemorrhagic stroke within 90 days of baseline testing
• Liver dysfunction during baseline testing, as evidenced by enzymes (e.g., AST, ALT, alkaline phosphatase) greater than 3 times upper limit of normal
• Diabetes with poorly controlled blood glucose levels (HbA1c > 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 <35 ml/min/1.73m2
• A contrast allergy that cannot adequately be managed by premedication
• Received gene or cell-based therapy from any source within the previous 12 months
• A hematologic abnormality during baseline testing as evidenced by hemoglobin < 9 g/dl; hematocrit < 30%; absolute neutrophil count < 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values < 100,000/ul
• 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) (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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• University of Florida-Department of Medicine — Gainesville, Florida, United States
• University of Miami-Interdiciplinary Stem Cell Institute — Miami, Florida, United States
• Indiana Center for Vascular Biology and Medicine — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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