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NCT06145035: CATO
Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
Phase 2 trial testing umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in Ischemic Heart Disease in 60 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Roberto Bolli |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 4 March 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- umbilical cord-derived mesenchymal stromal cells (UC-MSCs) — full drug profile →
Conditions studied
- Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
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):
-
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT06145035
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06145035 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Roberto Bolli
- Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06145035.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing