u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, single ascending dose, first in human, open-label, non-controlled, dose-escalation trial that will investigate intravenous infusions of Umbilical cord lining stem cells (UCLSCs) in Left Ventricular Assist Device (LVAD) patients.

This study will recruit patients from the Advanced Heart Failure and LVAD Clinic at the University of Florida, including recently implanted patients, as well as patients on chronic long-term support, with the goal of enrolling up to 9 subjects to participate in the study.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida

Criteria

Inclusion Criteria:

1. Be ≥ 18 years of age

2. Have heart failure with reduced ejection fraction and a durable centrifugal flow LVAD

3. Be on a stable regimen of heart failure medications for at least two weeks, including ACE/ARB/ARNi unless there is a documented contraindication to their use. These medications will be provided at an optimized, guideline-directed maximally tolerated dose.

Exclusion Criteria:

1. Durable Biventricular support

2. An axial flow LVAD

3. History of Crohn's Disease, Ulcerative Colitis, or other Inflammatory Bowel Disease on active treatment

4. LVAD implantation within the last 30 days

5. Anticipated need for non-cardiac surgery within the next 12 months

6. Evidence of active systemic infection at time of study product delivery

7. Evidence of infectious diseases such as hepatitis B, hepatitis C and HIV

8. Prior heart transplant recipients

9. Active cancer (or prior diagnosis of cancer within the past 2 years)

10. Recent (<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids [>1 mg/kg of prednisone equivalent], TNF-α blockers, cyclosporine) not including NSAIDs or corticosteroids used for IV dye allergy only)

11. Chronic auto-immune or auto-inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)

12. Recent or planned use of vaccination with live attenuated viruses within the next 30 days

13. Allergy to rubber or latex, or to DMSO.

14. Pregnancy or breastfeeding; fertile women must use contraception to avoid pregnancy.

15. Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)

16. Platelet count < 100K

17. Inability to maintain an INR of 2-3

18. Inability to give informed consent

19. Cognitive or language barriers that prohibit obtaining informed consent or any study elements (interpreter permitted)

20. Any other condition that, in the judgment of the Investigator, would be a contraindication to enrollment, study product administration, or follow-up