Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy (CATO)
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ClinicalTrials.gov Identifier: NCT06145035 |
Recruitment Status :
Recruiting
First Posted : November 22, 2023
Last Update Posted : March 7, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | November 1, 2023 | ||||||||
First Posted Date ICMJE | November 22, 2023 | ||||||||
Last Update Posted Date | March 7, 2024 | ||||||||
Actual Study Start Date ICMJE | March 4, 2024 | ||||||||
Estimated Primary Completion Date | January 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12) [ Time Frame: Baseline, 12 months ] Change in left ventricular ejection fraction as assessed via cardiac MRI. Units: %
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
Serious adverse events [ Time Frame: 2 hrs, 6 hrs, Months 2 & 6 ] Number of patients experiencing significant adjudicated clinical events including myocardial infarction (MI), stroke, pulmonary embolism, implantable cardioverter-defibrillator (ICD) firing for ventricular fibrillation/tachycardia, ventricular tachycardia (sustained and non-sustained), or hospitalization related to intravenous infusion of UC-MSCs.
Units: number of participants who have an incidence of SAE in each group
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy | ||||||||
Official Title ICMJE | University of Louisville - 18642 / CATO Study, Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy | ||||||||
Brief Summary | This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM). | ||||||||
Detailed Description | This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM) (see summary in Figure 1). A total of 60 participants will be assigned in a random fashion to three groups on a 1:1:1 basis: control, single dose, and repeated doses. All patients will receive four study product infusions (SPIs) 2 months apart. SPIs (performed in a double blind fashion) will consist of either UC MSCs or placebo (based on randomization), infused by the IV route. Patients in the control group will receive four doses of placebo. Patients in the single dose group will receive one dose of UC MSCs followed by three doses of placebo. Patients in the repeated dose group will receive four doses of UC MSCs. A dose of UC MSCs will consist of 100 million cells suspended in 60 mL, infused at a rate of 1 mL/min. A dose of placebo will consist of an equivalent volume of Plasma Lyte A supplemented with 1% human serum albumin (HSA). After each SPI, patients will be monitored for a minimum of 4 hours ± 30 minutes and then examined at 1 week and 2 months. After the fourth SPI, patients will be followed for 6 months to complete all safety and efficacy assessments. The UC MSCs will be derived from UC tissue obtained from a healthy pregnant woman at the time of caesarean delivery. The cells will be manufactured at the Interdisciplinary Stem Cell Institute at the University of Miami, Miller School of Medicine and then shipped to the Site for administration. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: randomized, double blind, placebo controlled, Masking: Double (Participant, Investigator)Masking Description: As a double-blind study, bias control will be achieved by maintaining the blind on treatment group assignments. The master randomization lists containing the treatment assignments will be protected in secure, controlled access drives/folders and will not be released to any blinded study personnel prior to final database lock. A centralized Core laboratory will be used for MRI analyses to maintain the blind across the study team. The designated cell processing technicians will prepare the investigational product for infusion. The investigational agent infusions will be prepared in identical infusion bags and labeled with the identical investigational drug labels as to preserve the blind. The designated technicians in the ISCI Cell Processing Laboratory (CPL) or designee will be responsible for maintaining the investigational product records including randomized treatment assignments by subject identification. |
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Condition ICMJE | Ischemic Heart Disease | ||||||||
Intervention ICMJE | Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs)
The study product will consist of 100 million UC-MSCs suspended in a final volume of 60 ml given at a rate of 1.6 million cells/min. The product will be infused into vein via intravenous line placed in the arm.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 1, 2026 | ||||||||
Estimated Primary Completion Date | January 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 85 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT06145035 | ||||||||
Other Study ID Numbers ICMJE | 23.0712 1369707 ( Other Grant/Funding Number: United States Department of Defence ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Roberto Bolli, University of Louisville | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Roberto Bolli | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Louisville | ||||||||
Verification Date | March 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |