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NCT06145035: CATO

Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy

Recruiting now Phase 2 Last updated 26 October 2024
What this trial tests

Phase 2 trial testing umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in Ischemic Heart Disease in 60 participants. Currently enrolling.

Timeline
4 March 2024
Primary endpoint
1 January 2026
1 January 2026

Quick facts

Lead sponsorRoberto Bolli
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date4 March 2024
Primary completion1 January 2026
Estimated completion1 January 2026
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Roberto Bolli — full company profile →

Who can join

Adults 21 to 85, any sex, with Ischemic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emerging Landscape of Mesenchymal Stem Cell Senescence Mechanisms and Implications on Therapeutic Strategies.
    Wang J, Zhang M, Wang H. · · 2024 · cited 13× · PMID 39144566 · DOI 10.1021/acsptsci.4c00284
  2. Intravenous infusions of mesenchymal stromal cells have cumulative beneficial effects in a porcine model of chronic ischaemic cardiomyopathy.
    Tang XL, Wysoczynski M, Gumpert AM, Solanki M, et al · · 2024 · cited 9× · PMID 39163570 · DOI 10.1093/cvr/cvae173
  3. 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.
    Bolli R, Tang XL, Hare JM, Mitrani RD, et al · · 2026 · PMID 41397478 · DOI 10.1016/j.ahj.2025.107328

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Other recruiting trials for Ischemic Heart Disease

Currently open trials in the same condition.

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Data sources for this page

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