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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.

NCT06705023 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-12-03

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Scientific Medical Center, Kazakhstan

    collaborator OTHER_GOV

  • Internationnal Foundation Medicine and Science

    collaborator UNKNOWN

  • Alliance of Cardiovascular Researchers

    collaborator OTHER

  • Ralf Rothoerl

    lead OTHER

Principal Investigators

  • Abay Baigenzhin, Prof Dr · National Scientific Medical Center

  • Ralf Rothoerl, Dr · International Foundation of Medicine and Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • Kazakhstan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06705023 on ClinicalTrials.gov