Phase 2
Completed N=25
Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
Source: ClinicalTrials.gov NCT00869024 ↗Enrolled (actual)
25
Serious AEs
80.0%
Results posted
Mar 2020
Primary outcomePrimary: Safety of Cell Delivery — 1; 0 adverse events
Summary
The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future.
The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from your pelvic bone using a needle and syringe. This would not take place until 24-48 hours prior to your planned left ventricular assist device implantation. During the surgery the surgeons will inject the prepared cells that were taken from your bone marrow and inject it into your heart muscle.
This study will test whether receiving your own bone marrow cells directly into your heart will help your heart to recover function after placement of a left ventricular assist device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Cell Delivery |
1; 0 | — |
| PRIMARY Improvement in Myocardial Viability by PET/CT Scan |
14; 4; 14; 4; 15; 4 | — |
| PRIMARY Combined End Points of Death |
2; 3 | — |
| SECONDARY Number of Participants Turned Down Without Meeting LVAD Stopping Rules |
12; 2 | — |
| SECONDARY Change in Left Ventricular Dimensions |
-0.49; -0.57; -0.73; -0.62 | — |
| SECONDARY Histological Assessment |
— | — |
Eligibility Criteria
Inclusion Criteria
- Severe LV dysfunction with EF 3.0, or are receiving chronic dialysis support.
- Inability to undergo PET/CT imaging.
- A history of any significant recent bleeding disorder or coagulation profile of concern for acute bleeding, such as INR >2.0 (not on anticoagulant), platelet count <100,000, or hemoglobin <8.0 gr/dl.
- Patients with known infectious disease (Hepatitis, HIV) etc.
- Patients with three times or more of the upper limits of normal enzymes.
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Data sourced from ClinicalTrials.gov (NCT00869024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.