Trial Search Results

Transendocardial Injection of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Joshua M Hare

Collaborator: United States Department of Defense

Stanford Investigator(s):

Intervention(s):

  • Biological: allogeneic human mesenchymal stem cells (hMSCs)
  • Other: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

   1. Men and women aged 18 to 80 years at the time of signing the informed consent form.

   2. Diagnosis of NIDCM with left ventricular ejection fraction ≤40%. Note: a left
   ventricular end diastolic diameter (LVEDD) ≥ 5.9cm in male subjects, an LVEDD of ≥
   5.6cm in female subjects, or left ventricular end diastolic volume index ≥ 125 mL/m2
   (in either sex).

   3. Appropriate guideline-directed optimal medical therapy for non-ischemic
   cardiomyopathy. At a minimum, subjects must be on beta blockers and
   angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)
   or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical
   indication precluding use of one or both of these agents. Subjects must be on a stable
   regimen for at least 30 days prior to the procedure. Dose titration is allowed.

   4. Be a candidate for cardiac catheterization.

   5. Be willing to undergo DNA test.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation
in this study:

   1. Be eligible for or require standard-of-care surgical or percutaneous intervention for
   the treatment of non-ischemic dilated cardiomyopathy.

   2. Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and
   concomitant clinical findings such as electrocardiogram changes suggestive of coronary
   ischemia, myocardial infarction) or evidence of endocardial or transmural scar on
   cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary
   intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or
   require coronary artery revascularization

   3. Documented presence of epicardial stenosis of 70% or greater in one or more major
   epicardial coronary arteries.

   4. Valvular heart disease including 1) mechanical or bioprosthetic left heart valve
   (mitral clip will be excluded); or 2) severe left-sided valvular (mital or aortic
   valve) insufficiency/regurgitation within 12 months of consent

   5. Aortic stenosis with valve area ≤ 1.5cm2

   6. Cardiomyopathy due to acute Post-partum (within 6 months), Non-compaction, or
   Hypertrophic cardiomyopathy.

   7. Cardiomyopathy due to any known toxin (e.g amyloid, anthracycline)

   8. Evidence of a life-threatening arrhythmia in the absence of a defibrillator
   (non-sustained ventricular tachycardia ≥ 20 consecutive beats or complete second or
   third-degree heart block in the absence of a functioning pacemaker) within 30 days of
   consent or the measure of the time interval between the start of the Q wave and the
   end of the T wave in the heart's electrical cycle (QTc) interval > 550 ms on baseline
   electrocardiogram (ECG).

   9. Automated Implantable Cardioverter Defibrillator (AICD) appropriate firing or anti
   tachycardia pacing for ventricular fibrillation within 30 days prior to consent.

10. Have an estimated baseline glomerular filtration rate <35 ml/min/1.73m2

11. A hematologic abnormality during baseline testing as evidenced by hemoglobin < 9 g/dl;
   hematocrit < 30%; absolute neutrophil count < 2,000 or total WBC count more than 2
   times upper limit of normal; or platelet values < 100,000/ul

12. Have liver dysfunction, as evidenced by enzymes Aspartate Transaminase Enzyme (AST)
   and Alanine Aminotransferase Enzyme (ALT) greater than three times the ULN.

13. Have a bleeding diathesis or coagulopathy (International Normalised Ratio (INR) >
   1.5), cannot be withdrawn from anticoagulation therapy, or will refuse blood
   transfusions.

14. Be a solid organ transplant recipient. This does not include prior cell based therapy
   (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.

15. Have a history of organ or cell transplant rejection.

16. Have a clinical history of malignancy within the past 2 years (i.e., subjects with
   prior malignancy must be disease free for 2 years), except curatively treated basal
   cell or squamous cell carcinoma or cervical carcinoma.

17. History of drug abuse (illegal "street" drugs except marijuana, or prescription
   medications not being used appropriately for a pre-existing medical condition) or
   alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or
   legal problems arising from the use of alcohol or drugs within the past 24 months.

18. Be serum positive for HIV, hepatitis B surface antigen, or viremic hepatitis C.

19. Documented presence of a known Left Ventricular (LV) thrombus, aortic dissection, or
   aortic aneurysm. (Refer to "Guidance to the PI" section with regards to LV thrombus,
   below).

20. Blood glucose levels (HbA1c) >10%

21. Severe radiographic contrast allergy.

22. Known allergies to penicillin or streptomycin

23. Hypersensitivity to dimethyl sulfoxide (DMSO).

24. Non-cardiac condition with life expectancy < 1 year.

25. Acute stroke or transient ischemic attack within 3 months of enrollment.

26. Be pregnant, nursing, or of childbearing potential while not practicing effective
   contraceptive methods.

27. Pacemaker-dependence with an Implantable Cardioverter Defibrillator (ICD) (Note:
   pacemaker-dependent candidates without an ICD are not excluded)

28. Presence of a pacemaker and/or ICD generator with any of the following
   limitations/conditions:

      - manufactured before the year 2000

      - leads implanted < 6 weeks prior to consent

      - non-transvenous epicardial or abandoned leads

      - subcutaneous ICDs

      - leadless pacemakers

29. A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to
   consent

30. Other MRI contraindications (e.g. subject body habitus incompatible with MRI)

31. Need for advanced heart failure therapy (e.g. IV inotropes)

32. Any other condition that in the judgment of the Investigator would be a
   contraindication to enrollment or follow-up.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Fouzia Khan
650-736-1410
Not Recruiting