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.
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