Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03797092
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Non-ischemic Dilated Cardiomyopathy Biological: Allogeneic adipose-derived stromal cells (CSCC_ASC) Other: Control group Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open randomized treatment group and control group clinical trial
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Active Comparator: Active
Allogeneic adipose-derived stromal cells (CSCC_ASC)
Biological: Allogeneic adipose-derived stromal cells (CSCC_ASC)
Active group
Other Name: Investigational medicinal product

Other: Control group
No treatment

No Intervention: Control group
No treatment



Primary Outcome Measures :
  1. Left ventricle end-systolic volume [ Time Frame: 6 months after treatment ]
    Measured using echocardiography


Secondary Outcome Measures :
  1. Allogeneic antibodies [ Time Frame: Up to 12 months after treatment ]
    Development of allogeneic antibodies and laboratory safety measurements 1, 3 and 6 months after treatment

  2. Left ventricular ejection fraction [ Time Frame: 6 months after treatment ]
    Changes in LVEF

  3. Myocardial mass of left ventricle [ Time Frame: 6 months after treatment ]
    Change in echo measured global myocardial mass

  4. NYHA [ Time Frame: 6 months after treatment ]
    Symptoms

  5. Kansas City Cardiomyopathy Questionnaire [ Time Frame: 6 months after treatment ]
    Questionnaire

  6. EQ-5D3L Questionnaire [ Time Frame: 6 months after treatment ]
    Questionnaire

  7. 6 min walking test [ Time Frame: 6 months ]
    Test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 30 to 80 years of age
  2. Signed informed consent
  3. Patients with non-ischemic dilated cardiomyopathy
  4. NYHA ≥ II in spite of optimal heart failure treatment and have no other treatment options
  5. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted
  6. LVEF ≤ 405%
  7. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)
  8. 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:

  1. Heart Failure NYHA I
  2. Moderate to severe aortic stenosis (valve area < 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
  3. Heart failure caused by cardiac valve disease or untreated hypertension.
  4. If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
  5. 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
  6. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
  7. Previous cardiac surgery
  8. 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
  9. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes > 14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
  10. Reduced kidney function (eGFR < 30 ml/min)
  11. Left ventricular thrombus
  12. Anticoagulation treatment that cannot be paused during cell injections.
  13. Patients with reduced immune response
  14. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
  15. Pregnant women
  16. Woman of childbearing potential unless βHCG negative and they should be on contraception during the trial
  17. Other experimental treatment within four weeks of baseline tests
  18. Participation in another intervention trial
  19. Life expectancy less than one year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797092


Contacts
Layout table for location contacts
Contact: Jens Kastrup, MD, DMSc 004535452819 jens.akstrup@regionh.dk
Contact: Abbas A Qayyum, MD, PhD 004535451076 abbas.ali.qayyum@regionh.dk

Locations
Layout table for location information
Denmark
The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Copenhagen, Denmark, 2100
Sponsors and Collaborators
JKastrup
University Medical Centre Ljubljana
Investigators
Layout table for investigator information
Principal Investigator: Bojan Vrtovec, MD, PhD Dep. of Cardiology, Uni. Medical Center Ljubljana, Slovenia

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: JKastrup, Professor, Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03797092     History of Changes
Other Study ID Numbers: SCIENCE II - Pilot
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The entire study will be published and shared with other researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by JKastrup, Rigshospitalet, Denmark:
Stem cell therapy
Heart failure
Clinical trial
Allogeneic

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly