Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJanuary 19, 2021
January 1, 2021
1.8 years
June 28, 2018
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricle end-systolic volume
Measured using echocardiography
6 months after treatment
Secondary Outcomes (7)
Allogeneic antibodies
Up to 12 months after treatment
Left ventricular ejection fraction
6 months after treatment
Myocardial mass of left ventricle
6 months after treatment
NYHA
6 months after treatment
Kansas City Cardiomyopathy Questionnaire
6 months after treatment
- +2 more secondary outcomes
Study Arms (2)
Active
ACTIVE COMPARATORAllogeneic adipose-derived stromal cells (CSCC\_ASC)
Control group
NO INTERVENTIONNo treatment
Interventions
Active group
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
- If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
- Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
- Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
- Previous cardiac surgery
- Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) \<1 L/min, moderate to severe claudication or morbid obesity
- Clinical significant anaemia (haemoglobin \< 6 mmol/L), leukopenia (leucocytes \< 2 109/L), leucocytosis (leucocytes \> 14 109/L) or thrombocytopenia (thrombocytes \< 50 109/L)
- Reduced kidney function (eGFR \< 30 ml/min)
- Left ventricular thrombus
- Anticoagulation treatment that cannot be paused during cell injections.
- Patients with reduced immune response
- Pregnant women
- Woman of childbearing potential unless βHCG negative and they should be on contraception during the trial
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JKastruplead
- University Medical Centre Ljubljanacollaborator
Study Sites (1)
The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Copenhagen, 2100, Denmark
Related Publications (1)
Kastrup J, Haack-Sorensen M, Juhl M, Harary Sondergaard R, Follin B, Drozd Lund L, Monsted Johansen E, Ali Qayyum A, Bruun Mathiasen A, Jorgensen E, Helqvist S, Jorgen Elberg J, Bruunsgaard H, Ekblond A. Cryopreserved Off-the-Shelf Allogeneic Adipose-Derived Stromal Cells for Therapy in Patients with Ischemic Heart Disease and Heart Failure-A Safety Study. Stem Cells Transl Med. 2017 Nov;6(11):1963-1971. doi: 10.1002/sctm.17-0040. Epub 2017 Sep 7.
PMID: 28880460RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bojan Vrtovec, MD, PhD
Dep. of Cardiology, Uni. Medical Center Ljubljana, Slovenia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The patients will be randomized to either IMP or control in a 2:1 randomization. The outcome ECHO investigations will be analyzed blinded by an independent core lab.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Doctor
Study Record Dates
First Submitted
June 28, 2018
First Posted
January 8, 2019
Study Start
October 1, 2019
Primary Completion
July 1, 2021
Study Completion
September 1, 2021
Last Updated
January 19, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
The entire study will be published and shared with other researchers