Status:
COMPLETED
u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding
Lead Sponsor:
University of Florida
Conditions:
Angiodysplastic Bleeding
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
Subjects will be entered into a 3+3 dose escalation study, a standard design for initial trials to evaluate tolerability of a therapeutic agent and identify a maximal tolerated dose if indeed toxiciti...
Eligibility Criteria
Inclusion
- Be ≥ 18 years of age
- Have heart failure with reduced ejection fraction and a durable centrifugal flow LVAD
- 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
- Durable Biventricular support
- An axial flow LVAD
- History of Crohn's Disease, Ulcerative Colitis, or other Inflammatory Bowel Disease on active treatment
- LVAD implantation within the last 30 days
- Anticipated need for non-cardiac surgery within the next 12 months
- Evidence of active systemic infection at time of study product delivery
- Evidence of infectious diseases such as hepatitis B, hepatitis C and HIV
- Prior heart transplant recipients
- Active cancer (or prior diagnosis of cancer within the past 2 years)
- 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)
- Chronic auto-immune or auto-inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
- Recent or planned use of vaccination with live attenuated viruses within the next 30 days
- Allergy to rubber or latex, or to DMSO.
- Pregnancy or breastfeeding; fertile women must use contraception to avoid pregnancy.
- Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
- Platelet count \< 100K
- Inability to maintain an INR of 2-3
- Inability to give informed consent
- Cognitive or language barriers that prohibit obtaining informed consent or any study elements (interpreter permitted)
- Any other condition that, in the judgment of the Investigator, would be a contraindication to enrollment, study product administration, or follow-up
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04811261
Start Date
November 1 2021
End Date
July 27 2023
Last Update
August 2 2023
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610