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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in left ventricular ejection fraction (LVEF)
Incidence of adverse events
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,782 Total Patients Enrolled
1 Trials studying Cardiomyopathy
7 Patients Enrolled for Cardiomyopathy
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,274 Total Patients Enrolled
1 Trials studying Cardiomyopathy
7 Patients Enrolled for Cardiomyopathy
Amanda OlsonPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
183 Total Patients Enrolled
1 Trials studying Cardiomyopathy
7 Patients Enrolled for Cardiomyopathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for me to join this medical trial?

"This clinical trial seeks to enroll 72 individuals with heart failure whose ages are between 18 and 80. The eligibility criteria for this study is as follows: patients must have a left ventricular ejection fraction of 40% or less due to treatment with anthracyclines, be able to perform the six-minute walk test, been treated with maximal medical therapy for heart failure, not had trastuzumab in the past 90 days if they did receive it previously, and sign an informed consent form from either themselves or their legal representative."

Answered by AI

Could you please explain the potential risks associated with Mesenchymal Stem Cell Transplantation?

"Considering the limited data available on Mesenchymal Stem Cell Transplantation, our team at Power has deemed it to be relatively low risk and thus gave it a score of 1."

Answered by AI

What tangible results is this experiment aiming to accomplish?

"The primary outcome monitored from Baseline to 6 months is the Incidence of adverse events. Other secondary outcomes tracked include Aborted death due to an Automatic Implantable Cardioverter Defibrillator (AICD) firing, Revascularization requirements, and Change in improvement of left ventricular systolic function as assessed by Left Ventricular Ejection Fraction (LVEF). Statistical analyses will be displayed via tables with confidence intervals of differences between investigational groups and control group; if significant at p < .05 level, then a gatekeeping procedure can compare two drugs using two-sample t-tests without adjustments for"

Answered by AI

Does this research protocol have an age restriction, and if so what is it?

"This medical experiment is seeking volunteers who are of legal age and under the octogenarian threshold."

Answered by AI

What is the capacity of this research project?

"That is correct. According to clinicaltrials.gov, the original posting for this trial was on July 18th 2020 and it has since been updated as recently as November 16th 2022. The study aims to recruit 72 patients from a single centre."

Answered by AI

Are there currently any openings for individuals to join this clinical trial?

"Yes, the details on clinicaltrials.gov affirms that this research is currently in search of volunteers. It was first published on July 18th 2020 and was revised lastly on November 16th 2022. 72 people will be required to take part at one site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. M D Anderson Cancer Center: < 48 hours
Average response time
  • < 2 Days
~18 spots leftby Jul 2025