Trial With Mesenchymal Stromal Cells (MSCs) vs Standard of Care in Cardiomyopathy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/11/2019 |
| Start Date: | January 2019 |
| End Date: | September 2025 |
| Contact: | Amanda L. Olson, MD |
| Email: | alolson@mdanderson.org |
| Phone: | 713-745-1505 |
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
Objectives:
Primary Objective To demonstrate the safety of allogeneic human mesenchymal stem cells
(hMSCs) administered by intravenous infusion and transendocardial injection in patients with
left ventricular (LV) dysfunction and heart failure secondary to chemotherapy with
anthracyclines.
Secondary Objective To demonstrate the efficacy of allogeneic hMSCs administered by
intravenous infusion and transendocardial injection in patients with left ventricular
dysfunction (left ventricular ejection fraction [LVEF] < 40%) and heart failure secondary to
treatment with anthracyclines.
Primary Objective To demonstrate the safety of allogeneic human mesenchymal stem cells
(hMSCs) administered by intravenous infusion and transendocardial injection in patients with
left ventricular (LV) dysfunction and heart failure secondary to chemotherapy with
anthracyclines.
Secondary Objective To demonstrate the efficacy of allogeneic hMSCs administered by
intravenous infusion and transendocardial injection in patients with left ventricular
dysfunction (left ventricular ejection fraction [LVEF] < 40%) and heart failure secondary to
treatment with anthracyclines.
Inclusion Criteria:
1. Patients with LVEF malignancy at any dose at any time without evidence of other causes of cardiomyopathy.
2. Age >/= 18 and
3. Documented NYHA class I, II and III.
4. Patients with persistent LV dysfunction 90 days after discontinuation of trastuzumab.
5. Able to perform 6 minute walk test.
6. Been treated with appropriate maximal medical therapy for heart failure.
7. Patient or legally authorized representative able to sign informed consent.
Exclusion Criteria:
1. Evidence of Ischemic Heart Disease as determined by study cardiologist.
2. Significant Valvular Disease. (AS with AVA <1.5 and severe AR and MR).
3. History of Familial Cardiomyopathy.
4. Recent documented myocarditis within 2 months of enrollment.
5. History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
6. eGFR < 50 by Mayo or Cockcroft formula.
7. Presence of left ventricular thrombus as documented by echocardiography or left
ventriculogram.
8. Liver function tests > 3 x upper limit of normal.
9. NYHA class IV heart failure.
10. Inotropic dependence.
11. Unstable or life-threatening arrhythmia.
12. Coagulopathy INR > 1.5.
13. Mechanical or Bioprosthetic heart valve.
14. Cardiogenic shock.
15. Breastfeeding and/or pregnant women.
16. Autoimmune disorders on current immunosuppressive therapy.
17. Active infection not responding to appropriate therapy as determined by Study Chair.
18. Trastuzumab treatment within the last 3 months.
19. Automatic implantable cardioverter defibrillator (AICD) placement within the last 30
days.
20. AICD firing within the last 30 days.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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