Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.

Recruiting Phase 2 Interventional Study
Myocardial Injury LV Dysfunction Coronary Artery Disease Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Ralf Rothoerl · Other
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About This Trial
To investigate patients suffering from iHF and a LVEF of equal or less than 40% despite best medical treatment safety and efficacy of a single retrograde intra-cardiac venous (i.cv.) injection of UA-ADRCs isolated from lipoaspirate at the point of care, using the Transpose® RT / Matrase System (InGeneron, Houston, TX, USA) through an over-the- wire, small balloon catheter, advanced through the cor…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * Have documented coronary artery disease with evidence of myocardial injury, LV dysfunction, and clinical evidence of heart failure * Have an EF ≤40% by cardiac MRI * Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥1 month befor…
Contacts

Anastassiya Ganina-Smelova, PhD

+77024346421

anastassiya_smelova@mail.ru

CONTACT

Aizhan Akhaeva, PhD

+77075008522

akhaeva@mail.ru

CONTACT