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NCT02962661SuspendedPhase 1

Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines

Randomized 3-Arm Trial With Standard of Care Alone vs Either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) Plus Standard of Care in Patients With Anthracycline-Associated Cardiomyopathy

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Reason given: PI Request

Brief summary (registry, in English)

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

Status (registry)
Suspended
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
72 (estimated)
First submitted
8 Nov 2016
Start date
18 Jul 2020
Primary completion date
30 Jul 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT02962661

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Evidence of Ischemic Heart Disease as determined by study cardiologist.
  • Significant Valvular Disease. (AS with AVA <1.5 and severe AR and MR)
  • History of Familial Cardiomyopathy.
  • History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
  • NYHA class IV heart failure.
  • Unstable or life-threatening arrhythmia.
  • Mechanical or Bioprosthetic heart valve.
  • Autoimmune disorders on current immunosuppressive therapy.
  • Active infection not responding to appropriate therapy as determined by Study Chair.

Lab values

  • For patients not on anticoagulants, INR>1.5

Other

  • Recent documented myocarditis within 2 months of enrollment.
  • Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
  • Liver function tests > 3 x upper limit of normal.
  • Inotropic dependence.
  • Cardiogenic shock.
  • Breastfeeding and/or pregnant women.
  • Trastuzumab treatment within the last 3 months.
  • Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days.
  • AICD firing within the last 30 days.

Who the study is looking for

  • Patients with LVEF </= 40% documented from treatment with anthracyclines for any malignancy at any dose at any time without evidence of other causes of cardiomyopathy.
  • Age >/= 18 and </= 90 years of age. English and non-English speaking patients are eligible.
  • Documented NYHA class I, II and III.
  • For patients who have received trastuzumab: Persistent LV dysfunction must be present 90 days after discontinuation of trastuzumab.
  • Able to perform 6 minute walk test.
  • Been treated with appropriate maximal medical therapy for heart failure.
  • Patient or legally authorized representative able to sign informed consent.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer CenterHoustonUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.