UnknownPhase 1/2

Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study

Denmark30 participantsStarted 2019-10-01

Plain-language summary

The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC\_ASC) investigational medicinal product, to improve myocardial function in patients with non-ischemic dilated cardiomyopathies (NIDCM) and heart failure.

Who can participate

Age range

30 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 30 to 80 years of age
. Signed informed consent
. Patients with non-ischemic dilated cardiomyopathy
. NYHA ≥ II in spite of optimal heart failure treatment and have no other treatment options
. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted
. LVEF ≤ 405%
. Plasma NT-pro-BNP \> 300 pg/ml (\> 35 pmol/L)
. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit

Exclusion criteria

. Heart Failure NYHA I
. Moderate to severe aortic stenosis (valve area \< 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
. Heart failure caused by cardiac valve disease or untreated hypertension.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Left ventricle end-systolic volume

Timeframe: 6 months after treatment

Trial details

NCT IDNCT03797092

SponsorJKastrup

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-01

Contact for this trial

Jens Kastrup, MD, DMSc

004535452819 jens.akstrup@regionh.dk

View on ClinicalTrials.gov More Non-ischemic Dilated Cardiomyopathy trials