Actively Recruiting
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.
Led by Ralf Rothoerl · Updated on 2024-12-03
36
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
R
Ralf Rothoerl
Lead Sponsor
N
National Scientific Medical Center, Kazakhstan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 coronary si-nus and located within a coronary vein at the site of inter-est, versus patients on best medical treatment.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented coronary artery disease with myocardial injury, left ventricular dysfunction, and clinical heart failure
- Left ventricular ejection fraction (LVEF) of 40% or less by cardiac MRI
- Receiving stable guideline-driven medical therapy for heart failure for at least 1 month before consent
- Candidate for right heart cardiac catheterization
- New York Heart Association (NYHA) class I, II, or III heart failure symptoms
- If female of childbearing potential, willing to use one form of birth control during the study and undergo pregnancy tests at baseline and within 36 hours before treatment
You will not qualify if you...
- Need for standard-of-care surgery (valve surgery, LV assist device placement, imminent heart transplant) or recent coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months
- Valvular heart disease including mechanical or bioprosthetic valves, severe valve insufficiency/regurgitation within 12 months, or aortic stenosis with valve area ≤1.5 cm2
- Stroke within 90 days before consent
- History of LV remodeling surgery with prosthetic material
- Presence of certain pacemakers or ICD devices implanted before 2015, recent lead implantation (<6 weeks), non-transvenous or abandoned leads, subcutaneous ICDs, leadless pacemakers, or pacemaker dependence with ICD
- Contraindication for MRI as judged by device-trained staff
- Cardiac resynchronization therapy (CRT) device implanted within 3 months
- Recent appropriate ICD firing or antitachycardia pacing within 30 days
- Ventricular tachycardia ≥20 beats without ICD or symptomatic high-degree atrioventricular block without pacemaker within 3 months
- Presence of left ventricular thrombus
- Estimated glomerular filtration rate (eGFR) below 35 mL/min/1.73 m2
- Poorly controlled diabetes (HbA1c >10%)
- Hematologic abnormalities (hematocrit <25%, white blood cells <2500/µL, platelets <100,000/µL)
- Liver dysfunction with enzymes ≥3 times upper limit of normal
- Coagulopathy (INR ≥1.3) not due to reversible cause
- Active infections with HIV, hepatitis B or C
- Allergy to contrast agents not manageable by premedication
- History of anaphylaxis to penicillin or streptomycin
- Receipt of gene or cell-based therapy within 12 months
- Malignancy within 3 years except certain treated skin or cervical cancers
- Life expectancy less than 1 year
- History of drug or alcohol abuse
- Chronic immunosuppressant therapy
- Cognitive or language barriers preventing informed consent
- Pregnancy, lactation, or plans to become pregnant within 12 months
- Other conditions judged to impair enrollment, cell harvest, treatment, or follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Scientific Medical Center
Astana, Kazakhstan, 010009
Actively Recruiting
Research Team
A
Anastassiya Ganina-Smelova, PhD
CONTACT
A
Aizhan Akhaeva, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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