RecruitingPhase 2NCT06705023

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.

Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure


Sponsor

Ralf Rothoerl

Enrollment

36 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting a patient's own fat-derived stem cells (harvested by liposuction) into the heart can improve function in people with chronic heart failure caused by blocked arteries. **You may be eligible if...** - You have coronary artery disease with documented heart damage and weak heart pump function (ejection fraction 40% or less) - You have been on stable heart failure medications for at least one month - You have mild-to-moderate heart failure symptoms (NYHA Class I, II, or III) - You are a candidate for a right-heart catheterization procedure **You may NOT be eligible if...** - You need heart bypass surgery, valve surgery, a mechanical heart pump, or a heart transplant - You had bypass surgery or a heart stent procedure in the last 3 months - You have significant valve disease or a history of stroke in the last 90 days - You have a pacemaker or defibrillator that is older than 2015 or has certain technical limitations incompatible with MRI - Your kidneys, blood counts, liver, or blood sugar are significantly impaired - You are HIV-positive or have active hepatitis B or C - You have had cancer in the past 3 years (except certain skin or cervical cancers) - You are pregnant or planning to become pregnant within 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUncultured, autologous, adipose-derived regenerative cells (UA-ADRCs)

Intracardial venous injection of fresh, uncultured, autologous, adipose-derived regenerative cells isolated from lipoaspirate at the point of care.

OTHERContinuation of patient's best guideline based medical treatment

Patients will receive continuation of their best guideline based medical treatment.


Locations(1)

National Scientific Medical Center

Astana, Kazakhstan

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NCT06705023


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