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ASCs in Recently Diagnosed Non-ischemic Heart Failure

NCT06840275 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-04-01

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the efficacy and safety of intravenous infusions of allogeneic adipose tissue-derived mesechymal stromal cells in patients with recently diagnosed non-ischemic heart failure in restoring cardiac function compared to placebo. The primary outcome of this trial is the change in left ventricular ejection fraction 6 month after treatment compared to placebo. Participants will be given two treatments with one month apart of either allogeneic adipose tissue-derived mesechymal stromal cells or placebo.

Conditions

  • Non-Ischemic Heart Failure
  • Reduced Ejection Fraction Heart Failure

Interventions

DRUG

Allogeneic adipose tissue-derived mesenchymal stem cells

Two intravenous infusions of C2C\_ASC110 1 month apart. The C2C\_ASC110 product contains 110 million cells.

OTHER

Cryostor CS10

Two intravenous infusions of CryoStor CS10 1 month apart.

Sponsors & Collaborators

  • Cell to Cure ApS

    lead INDUSTRY

Principal Investigators

  • Abbas A Qayyum, MD MSc PhD · Cardiology Stem Cell Centre, Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-09-01
Completion
2028-09-01

Countries

  • Denmark

Study Locations

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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 NCT06840275 on ClinicalTrials.gov