BridgeMD
New treatment option for Cardiomyopathy
Official title Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
ClinicalTrials.gov ID: NCT02962661
What this study is testing
What is Mesenchymal Stem Cell Transplantation?
Mesenchymal Stem Cell Transplantation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with LVEF \</= 40% documented from treatment with anthracyclines for any malignancy at any dose at any time without evidence of other causes...
- 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.
You likely can't join if
- 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.
- Recent documented myocarditis within 2 months of enrollment.
- History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
- Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
See the full eligibility criteria
- 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.
- 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.
- Recent documented myocarditis within 2 months of enrollment.
- History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
- Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
- Liver function tests \> 3 x upper limit of normal.
- NYHA class IV heart failure.
- Inotropic dependence.
- Unstable or life-threatening arrhythmia.
- For patients not on anticoagulants, INR\>1.5
- Mechanical or Bioprosthetic heart valve.
- Cardiogenic shock.
- Breastfeeding and/or pregnant women.
- Autoimmune disorders on current immunosuppressive therapy.
- Active infection not responding to appropriate therapy as determined by Study Chair.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.