NCT00612911: Bone-marrow cells for idiopathic dilated cardiomyopathy

This uncontrolled pilot infused autologous bone-marrow mononuclear cells into the coronary circulation of 24 patients with idiopathic dilated cardiomyopathy. Participants had substantial left-ventricular dysfunction and were followed for six months. 1 2

The report recorded four deaths between six and twelve weeks, two transient arrhythmias, and one transient cardiac-enzyme elevation. Among surviving participants with paired measurements, six-minute walk distance increased from approximately 377 to 444 metres, and quality-of-life and exercise measures improved. Left-ventricular ejection fraction did not improve. 1 2

There was no untreated or placebo group, and deceased participants were excluded from paired follow-up analyses. Consequently, natural variation, concurrent care, and survivor selection limit causal interpretation. The observed deaths must be reported, but this uncontrolled report does not establish that the cell infusion caused them. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00612911. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00612911. Original study registration: sponsor, design, population, endpoints and dated history.

2. Original full-text pilot: Martino et al., 2010 — Original full-text pilot: Martino et al., 2010Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.