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Mesenchymal Stem Cell Therapy

Mesenchymal Stem Cell Transplantation for Heart Failure

Phase 1

Recruiting

Led By Amanda Olson

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >/= 18 and </= 80 years of Age

Able to perform 6 minute walk test.

Must not have

Evidence of Ischemic Heart Disease as determined by study cardiologist

Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects of donor bone marrow derived mesenchymal stem cells in patients with cardiomyopathy caused by anthracyclines. The cells may help to control symptoms of heart failure and improve heart function.

Who is the study for?

This trial is for adults aged 18-80 with heart failure due to cardiomyopathy caused by anthracyclines used in cancer treatment. Participants must have a left ventricular ejection fraction (LVEF) of 40% or less, be classified as NYHA class I, II, or III, and able to walk for six minutes. Excluded are those with ischemic heart disease, severe valve disease, familial cardiomyopathy, liver issues, the most severe heart failure (NYHA class IV), certain blood clotting and valve conditions.

What is being tested?

The study tests whether mesenchymal stem cells from donor bone marrow can control symptoms and improve heart function in patients with anthracycline-induced cardiomyopathy. It's a phase I pilot trial that randomly assigns participants to receive either these stem cells or follow best practice care without them.

What are the potential side effects?

Potential side effects may include immune reactions since the stem cells come from donors; however specific side effects aren't listed here. As this is an early-phase trial assessing safety and efficacy, close monitoring will occur for any adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I can walk for 6 minutes without assistance.

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My heart's pumping ability is reduced due to cancer treatment.

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My heart's pumping ability is reduced due to cancer treatment.

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My heart condition does not prevent me from performing everyday activities.

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I can walk for 6 minutes without assistance.

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My heart condition does not prevent me from performing everyday activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart condition has been confirmed as ischemic by a cardiologist.

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I have a blood clot in my heart's left chamber.

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I have severe heart failure.

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I do not have a dangerous irregular heartbeat.

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I am on medication to suppress my immune system due to an autoimmune disorder.

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I need medication to help my heart pump better.

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I have had a severe heart condition called cardiogenic shock.

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I have received Trastuzumab treatment in the last 3 months.

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I have a family history of heart muscle disease.

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I have a serious heart valve condition.

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I have a history of heart muscle disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in left ventricular ejection fraction (LVEF)

Incidence of adverse events

Secondary study objectives

Aborted death from an automatic implantable cardioverter defibrillator (AICD) firing

Cardiac death

Change in improvement of left ventricular (LV) systolic function as assessed by LVEF

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (hMSCs transendocardially)Experimental Treatment3 Interventions

Patients receive hMSCs transendocardially for a total of 15 injections and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (hMSCs IV)Experimental Treatment3 Interventions

Patients receive hMSCs IV over 10-20 minutes on days 1, 14, 21, and 28 and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.

Group III: Arm III (standard of care)Active Control2 Interventions

Patients receive standard of care treatment for heart failure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesenchymal Stem Cell Transplantation

2016

Completed Phase 1

~20

0 / 18Eligibility criteria met