Ischemic Heart DiseasePhase 2CATONCT06145035
Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
A Phase 2 study testing umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in people with Ischemic Heart Disease, run by Roberto Bolli at 3 sites in United States.
Trial 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, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- umbilical cord-derived mesenchymal stromal cells (UC-MSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Mar 2024to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 21 and ≤ 85 years of age.
- Have documented CAD (> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.
- Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.
- Have an EF ≤ 40% by MRI.
- Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists, hydralazine isosorbide, sodium-glucose transporter 2 inhibitors) ) at stable, maximally tolerated doses for ≥ 1 month prior to consent. "Stable" is defined as stable dose with no changes for 30 days after last dose adjustment. For beta blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.
- Have NYHA class I, II or III symptoms of HF (see Appendix A)
- If a female of childbearing potential, be willing to use one form of birth control for the duration of the study and undergo a serum pregnancy test at baseline and within 36 hours prior to infusion
Who cannot join
- Indication for standard of care surgery (including valve surgery, placement of left ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and/or percutaneous coronary intervention (PCI) for the treatment of ischemic and/or valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 3 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS 1A or 1B, and they must have documented a low probability of being transplanted.
- Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
- History of ischemic or hemorrhagic stroke within 90 days of consent
- Presence of a pacemaker and/or implantable cardiac device (ICD) generator with any of the following limitations/conditions:
- manufactured before the year 2000
- leads implanted < 6 weeks prior to consent
Show all 30Show fewer
- non transvenous epicardial or abandoned leads
- subcutaneous ICDs (if not MRI compatible)
- leadless pacemakers
- any other condition that, in the judgment of device trained staff, would deem an MRI contraindicated
- Pacemaker dependence with an ICD (Note: pacemaker dependent candidates without an ICD are not excluded)
- A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent.
- Other MRI contraindications (e.g. patient body habitus incompatible with MRI)
- An appropriate ICD firing or anti tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent
- Ventricular tachycardia ≥ 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent
- Evidence of active myocarditis
- Baseline glomerular filtration rate (eGFR) < 35 ml/min/1.73m2
- Blood glucose levels (HbA1c) >10%
- Hematologic abnormality evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet count < 100,000/ul
- Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the ULN.
- HIV and/or active HBV or HCV
- Known history of anaphylactic reaction to penicillin or streptomycin
- Received gene or cell based therapy from any source within the previous 12 months.
- History of malignancy within 2 years (i.e., subjects with prior malignancy must be disease free for 2 years), excluding basal cell carcinoma and cervical carcinoma in situ which have been definitively treated.
- Condition that limits lifespan to < 1 year
- 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 12 months.
- Participation in an investigational therapeutic or device trial within 30 days of consent
- Cognitive or language barriers that prohibit obtaining informed consent or any study elements
- Pregnancy or lactation or plans to become pregnant in the next 12 months.
- Any other condition that, in the judgment of the Investigator or Sponsor, would impair enrollment, study product administration, or follow up.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Texas Heart Institute Houston Texas
Houston, Texas, 77030
Emerson Perin, MD, 832-355-9173, eperin@texasheart.org
Nicole Piece, 832-355-9173, npiece@texasheart.org
- Recruiting
University of Louisville School of Medicine, Institute of Molecular Cardiology
Louisville, Kentucky, 40202
Roberto Bolli, MD, 502-608-5426, rbolli@louisville.edu
Michelle Unseld, RN, 502-540-3423, michelle.unseld@louisville.edu
- Recruiting
University of Miami Miller School of Medicine
Miami, Florida, 33136
Joshua Hare, MD, 305-243-1152, JHare@med.miami.edu
Ana Garzon, 305-243-1152, amg9460@med.miami.edu
About this study
Official title: University of Louisville - 18642 / CATO Study, Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
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, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).
Read the 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, stem cells), 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 (stem cells) 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 (stem cells) followed by three doses of placebo. Patients in the repeated dose group will receive four doses of UC MSCs (stem cells). A dose of UC MSCs will consist of 100 million cells suspended in 60 mL, infused at a rate of 2 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 2 hours 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- umbilical cord-derived mesenchymal stromal cells (UC-MSCs)
- Keywords
- ischemic cardiopathy, UC-MSCs
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord-derived mesenchymal stromal cells (UC-MSCs)Biological
The study product will consist of 100 million UC-MSCs suspended in a final volume of 60 ml given at a rate of 3.3 million cells/min. The product will be infused into vein via intravenous line placed in the arm.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Four doses of vehicle (Plasma-Lyte A supplemented with 1% HSA) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes. Receives: Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs) |
| single-dose group | Experimental | One dose of UC-MSCs (100 x 106 cells) will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min). This will be followed by three IV infusions of placebo (same volume and rate) 2, 4, and 6 months later. Receives: Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs) |
| repeated-dose group | Experimental | Four doses of UC-MSCs (100 x 106 cells each) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min). Receives: Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12)
Change in left ventricular ejection fraction as assessed via cardiac MRI. Units: %
Measured: Baseline, 12 months
Secondary outcomes (18)
Change in LV end-systolic volume index (ESVI)
Change in left ventricular end systolic index (LVESVI) as assessed via cardiac MRI.
Units: ml/m2
Measured: Baseline, 12 months
Change in LV end-diastolic volume index (EDVI)
Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI.
Units: ml/m2
Measured: Baseline, 12 months
Change in LV end-diastolic wall thickness
Change in LV end-diastolic wall thickness as assessed via cardiac MRI. Units: mm
Measured: Baseline, 12 months
Change in LV wall thickening
Change in LV wall thickening as assessed via cardiac MRI. Units: mm
Measured: Baseline, 12 months
Change in LV sphericity index
Change in LV sphericity index as assessed via cardiac MRI. Units: Index score Sphericity index is the ratio of the long and short axis measurements of the left ventricle.
Measured: Baseline, 12 months
Change in global and regional strain (tagged MRI): global and 16-segment values for peak circumferential strain, global and segmental longitudinal strain
Change in global and regional strain as assessed via cardiac MRI. Units: %
Measured: Baseline, 12 months
Change in scar mass (in grams)
Change in scar mass (in grams) as assessed via delayed gadolinium enhancement MRI.
Units: grams
Measured: Baseline, 12 months
Change in scar mass (as %LV)
Change in scar mass (as %LV) as assessed via delayed gadolinium enhancement MRI.
Units: %
Measured: Baseline, 12 months
Change in VO2 max (treadmill test)
Change in maximal oxygen consumption (peak VO2) as assessed via treadmill. Units: mL/kg/min
Measured: Baseline, month 8, month 12
Change in exercise tolerance (six-minute walk test)
Change in exercise tolerance as assessed as the distance covered via the six-minute walk test.
Units: meters
Measured: Baseline, month 8, month 12
Change in New York Heart Association class
NYHA Classifications of heart failure are as follows: Class I (no limitations); Class II (mild symptoms); Class III (marked limitations); Class IV (Severe limitations).
Units: score on a scale
Measured: Baseline, month 2,4,6,8, & 12
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
KCCQ is a 12-item questionnaire in which scores are scaled from 0 to 100 and summarized in ranges to represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Units: score on a scale
Measured: Baseline, month 6, month 12
Change in Endothelial Progenitor Cell [EPC]-colony forming unit [EPC-CFU] assay
Change in endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay.
Units: CFUs/well
Measured: Baseline, month 2, 8, & 12
Change in branchial artery flow-mediated dilation [FMD] [diameter percent change]).
Change in branchial artery flow-mediated dilation will be reported as the percent change in flow mediated diameter assessed via flow mediated dilation (FMD).
Units: %
Measured: Baseline, month 2, 8, & 12
Major adverse cardiac events (MACE)
Number of participants with adjudicated events including death, hospitalization for worsening HF, and exacerbation of HF requiring visit to the Emergency Department and/or IV therapy but not requiring hospitalization.
Units: number of participants who have an incidence of MACE in each group
Measured: Month 12
Cumulative days alive and out of hospital for HF
Days alive and out of hospital during the study evaluation period. Units: days
Measured: Month 12
Biomarkers: Change in NT-proBNP
Change in NT-proBNP as assessed via blood draw. Units: pg/ml
Measured: Day 0, Month 2, 4, 6, 8, & 12
Biomarkers: hs-CRP
Blood level of hs-CRP as assessed via blood draw. Units: mg/ml
Measured: Day 0, Week 1, Month 2, 4, 6, 8, & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start4 Mar 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind, placebo controlled,
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roberto Bolli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, University of Texas, United States Department of Defense
- Responsible party
- Sponsor-investigator, Roberto Bolli, University of Louisville
- Investigators
- Roberto Bolli, MD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145035
- Sponsor's protocol ID
- 23.0712
- Other IDs
- 1369707
- Acronym
- CATO
- Status last verified
- May 2026
- First submitted
- 1 Nov 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolli R, Tang XL, Hare JM, Mitrani RD, Perin EC, Lima JA, Hurwitz BE, Kalra D, Singh G, Saltzman RG, Caceres LV, Nettina A, Lee YS, Bacallao K, Grant E, Khan A. Design and rationale of CATO, a Phase IIA, randomized, double-blind, placebo-controlled study of single or repeated intravenous administration of umbilical cord-derived mesenchymal stromal cells in ischemic cardiomyopathy. Am Heart J. 2026 Apr;294:107328. doi: 10.1016/j.ahj.2025.107328. Epub 2025 Dec 13.
PubMed 41397478Tang XL, Wysoczynski M, Gumpert AM, Solanki M, Li Y, Wu WJ, Zheng S, Ruble H, Li H, Stowers H, Zheng S, Ou Q, Tanveer N, Slezak J, Kalra DK, Bolli R. Intravenous infusions of mesenchymal stromal cells have cumulative beneficial effects in a porcine model of chronic ischaemic cardiomyopathy. Cardiovasc Res. 2024 Dec 4;120(15):1939-1952. doi: 10.1093/cvr/cvae173.
PubMed 39163570
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Louisville - 18642 / CATO Study, Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06145035
- Acronym / sponsor ID
- CATO / 23.0712
- Conditions
- Ischemic Heart Disease
- Keywords
- ischemic cardiopathy, UC-MSCs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Roberto BolliUniversity, hospital or other
- Collaborators
- University of Miami, University of Texas, United States Department of Defense
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, stem cells), 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, stem cells), 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 (stem cells) 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 (stem cells) followed by three doses of placebo. Patients in the repeated dose group will receive four doses of UC MSCs (stem cells). A dose of UC MSCs will consist of 100 million cells suspended in 60 mL, infused at a rate of 2 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 2 hours 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- randomized, double blind, placebo controlled,
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs)Four doses of vehicle (Plasma-Lyte A supplemented with 1% HSA) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes. |
| single-dose group | Experimental | Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs)One dose of UC-MSCs (100 x 106 cells) will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min). This will be followed by three IV infusions of placebo (same volume and rate) 2, 4, and 6 months later. |
| repeated-dose group | Experimental | Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs)Four doses of UC-MSCs (100 x 106 cells each) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min). |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be ≥ 21 and ≤ 85 years of age.
- Have documented CAD (> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.
- Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.
- Have an EF ≤ 40% by MRI.
- Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists, hydralazine isosorbide, sodium-glucose transporter 2 inhibitors) ) at stable, maximally tolerated doses for ≥ 1 month prior to consent. "Stable" is defined as stable dose with no changes for 30 days after last dose adjustment. For beta blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.
Key exclusion criteria (30 listed)
- Indication for standard of care surgery (including valve surgery, placement of left ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and/or percutaneous coronary intervention (PCI) for the treatment of ischemic and/or valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 3 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS 1A or 1B, and they must have documented a low probability of being transplanted.
- Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
- History of ischemic or hemorrhagic stroke within 90 days of consent
- Presence of a pacemaker and/or implantable cardiac device (ICD) generator with any of the following limitations/conditions:
- Pacemaker dependence with an ICD (Note: pacemaker dependent candidates without an ICD are not excluded)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 3.3 million cells/min. The product will be infused into vein via intravenous line placed in the arm. | Biological | control group, repeated-dose group, single-dose group |
Primary outcome
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: %
18 secondary outcomes
Change in LV end-systolic volume index (ESVI)
Time frame: Baseline, 12 months
Change in LV end-diastolic volume index (EDVI)
Time frame: Baseline, 12 months
Change in LV end-diastolic wall thickness
Time frame: Baseline, 12 months
Change in LV wall thickening
Time frame: Baseline, 12 months
Change in LV sphericity index
Time frame: Baseline, 12 months
Change in global and regional strain (tagged MRI): global and 16-segment values for peak circumferential strain, global and segmental longitudinal strain
Time frame: Baseline, 12 months
Change in scar mass (in grams)
Time frame: Baseline, 12 months
Change in scar mass (as %LV)
Time frame: Baseline, 12 months
Change in VO2 max (treadmill test)
Time frame: Baseline, month 8, month 12
Change in exercise tolerance (six-minute walk test)
Time frame: Baseline, month 8, month 12
Change in New York Heart Association class
Time frame: Baseline, month 2,4,6,8, & 12
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Baseline, month 6, month 12
Change in Endothelial Progenitor Cell [EPC]-colony forming unit [EPC-CFU] assay
Time frame: Baseline, month 2, 8, & 12
Change in branchial artery flow-mediated dilation [FMD] [diameter percent change]).
Time frame: Baseline, month 2, 8, & 12
Major adverse cardiac events (MACE)
Time frame: Month 12
Cumulative days alive and out of hospital for HF
Time frame: Month 12
Biomarkers: Change in NT-proBNP
Time frame: Day 0, Month 2, 4, 6, 8, & 12
Biomarkers: hs-CRP
Time frame: Day 0, Week 1, Month 2, 4, 6, 8, & 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 41397478Bolli R, Tang XL, Hare JM, Mitrani RD, Perin EC, Lima JA, Hurwitz BE, Kalra D, Singh G, Saltzman RG, Caceres LV, Nettina A, Lee YS, Bacallao K, Grant E, Khan A. Design and rationale of CATO, a Phase IIA, randomized, double-blind, placebo-controlled study of single or repeated intravenous administration of umbilical cord-derived mesenchymal stromal cells in ischemic cardiomyopathy. Am Heart J. 2026 Apr;294:107328. doi: 10.1016/j.ahj.2025.107328. Epub 2025 Dec 13.
- Derived from this study: PubMed 39163570Tang XL, Wysoczynski M, Gumpert AM, Solanki M, Li Y, Wu WJ, Zheng S, Ruble H, Li H, Stowers H, Zheng S, Ou Q, Tanveer N, Slezak J, Kalra DK, Bolli R. Intravenous infusions of mesenchymal stromal cells have cumulative beneficial effects in a porcine model of chronic ischaemic cardiomyopathy. Cardiovasc Res. 2024 Dec 4;120(15):1939-1952. doi: 10.1093/cvr/cvae173.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Bolli, MD principal investigator
University of Louisville School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in people with Ischemic Heart Disease, run by Roberto Bolli at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Bolli, MD (502-608-5426, rbolli@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12) (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145035, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.