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RECRUITING
NCT06705023
PHASE2

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.

Sponsor: Ralf Rothoerl

View on ClinicalTrials.gov

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.

Official title: Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-11-18

Completion Date

2025-12-31

Last Updated

2024-12-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Uncultured, 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.

OTHER

Continuation 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