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Heart FailurePhase 3CHART-1NCT01768702

Safety and Efficacy of Autologous Cardiopoietic Cells for Treatment of Ischemic Heart Failure.

A Phase 3 study testing Injection of C3BS-CQR-1 in people with Heart Failure, run by Celyad Oncology SA at 35 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Injection of C3BS-CQR-1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
35 sitesin 9 countries
Study dates
Nov 2012to Aug 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible patients must meet all of the following inclusion criteria:
  • Age ≥ 18 and < 80 years.
  • Systolic dysfunction with left ventricular ejection fraction (LVEF) ≤ 35% as assessed by echocardiography.
  • Ischemic heart failure without known need for revascularization.
  • Total MLHFQ score > 30.
  • Ability to perform a 6 minute walk test > 100 m and ≤ 400 m.
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  • History of hospitalization for heart failure (HF) within 12 months prior to screening or treatment in an outpatient clinic with intravenous vasoactive therapy (including vasodilators, positive inotropic agents and vasopressors) or diuretics for worsening Heart Failure within 12 months prior to screening.
  • Be or must have been within the previous 12 months in New York Heart Association (NYHA) Class III or IV or Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA Class II or greater.
  • Use of ACE inhibitor and/or angiotensin receptor blocker (ARB); and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated.
  • Stable dosing of ACE inhibitor, angiotensin receptor blocker , beta blocker, aldosterone blocker,and diuretics for at least one month prior to screening visit, defined as ≤50% change in total dose of each agent.
  • Willing and able to give written informed consent.

Who cannot join

  • Eligible patients must meet none of the following exclusion criteria:
  • Women who are pregnant, confirmed by a positive urine or serum human chorionic gonadotropin laboratory test at screening.
  • Women of child-bearing potential without a negative serum or urine pregnancy test at screening. Women who are postmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level > 40 mIU/mL or 6 weeks post surgical bilateral oophorectomy) or surgically sterile are not considered to be of child-bearing potential. Reliable contraception includes surgical sterilization, hormonal contraception, or doublebarrier methods.
  • Men refusing to exercise a reliable form of contraception.
  • Myocardial infarction, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or coronary artery bypass graft surgery within 180 days prior to screening.
  • Patient on a cardiac transplant list or previously received any solid organ transplant.
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  • Previously underwent cardiac surgery with remodeling procedure, left ventricular assist device placement or cardiomyoplasty. This exclusion does not apply to patients who underwent ventricularplasty without placement device more than one year ago.
  • Patient has undergone cardiac resynchronization therapy within 6 months prior to screening.
  • Severe uncontrolled HF requiring need for intensive intravenous diuretics or inotropic support within 1 month prior to screening.
  • Inability to perform a 6 minute walk test due to physical limitations other than HF including:
  • Severe peripheral vascular disease
  • Severe pulmonary disease or chronic obstructive pulmonary disease limiting exercise
  • Orthopedic limitations, severe muscular diseases, any other joint or muscular disease or neurological disorder (such as an old stroke or neuropathy) limiting the ability to walk for 6 minutes.
  • Dependence on chronic oral steroid therapy.
  • Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening.
  • Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy.
  • BMI < 19 or > 45.
  • Left ventricular thrombus.
  • Left ventricular (LV) wall thickness < 8mm visualized in more than 50% of LV, and defined as a "LV no-go zone".
  • LV aneurysm or candidate for surgical aneurysmectomy.
  • Sustained ventricular tachycardia or ventricular fibrillation which led to automatic implantable cardioverter/defibrillator (AICD) therapy (shock) within 3 months prior to screening.
  • Primary significant organic valvular heart disease.
  • Moderate to severe aortic valve disease precluding catheter entry into the LV.
  • Mechanical prosthetic valve in aortic or mitral position.
  • Chronic infection or active malignancy.
  • Patient has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 mmol/L) or is currently on dialysis.
  • Hematocrit < 28%.
  • Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree that could impede or preclude the safe retrograde passage of the delivery catheter.
  • Chronic immunosuppressive therapy due to inflammatory or systemic disease.
  • Patient tested positive for HIV 1 or 2, Hepatitis B or C, human T-cell lymphotrophic virus (HTLV) 1 or 2 (if required by regulations) or syphilis.
  • Exposure to any previous experimental cell or angiogenic therapy and/or myocardial laser therapy and/or therapy with another investigational drug within 60 days prior to screening or enrollment in any concurrent study that may confound the results of this study.
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate.
  • Any illness other than congestive heart failure which might reduce life expectancy to less than 2 years from screening.
  • Known and relevant allergies and/or hypersensitivities to Dextran or other plasma volume expanders to include Gentran, Hyskon and Macrodex.

Trial locations and contacts

35 sites in 9 countries.

35 sites in 9 countries

Serbia6 sites

  • Clinic of Emergency Internal Medicinne Military Medical Academy

    Belgrade, 11000

  • Clinical Center of Serbia - Cardiology Clinic

    Belgrade, 11000

  • Clinical Centre of Serbia, Cardiology Clinic

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara - Cardiology Clinic

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa, Cardiology Dept.

    Belgrade, 11080

  • Clinical Center of Kragujevac,

    Kragujevac, 34 000

Other trials in Serbia

Belgium5 sites

  • OLV Ziekenhuis Aalst

    Aalst, 9300

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

  • Hopital Civil Marie Curie

    Lodelinsart, 6042

  • AZ Glorieux

    Ronse, 9600

  • CHU Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Hungary5 sites

  • Gottsegen György Országos Kardiológiai Intézet - Felnőtt Kardiológiai Osztály

    Budapest, 1096

  • Semmelweis Egyetem - Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122

  • MH Egészségügyi Központ Kardiológiai Osztály

    Budapest, 1134

  • Debreceni Egyetem Orvos - és Egészségtudomanyi Centrum

    Debrecen, 4032

  • Pécsi Tudományegyetem Klinikai Központ - Szívgyógyászati Klinika

    Pécs, 7624

Other trials in Hungary

Israel5 sites

  • Barzilai Medical Center - Cardiology Unit

    Ashkelon, 78278

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Western Galilee Hospital

    Nahariya

  • Nazareth Hospital EMMS

    Nazareth, 16100

  • Ziv Medical Center - Heart Institute

    Safed, 13110

Other trials in Israel

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne, KliniczneCentrum Kardiologii

    Gdansk, 80-126

  • Górnośląskie Centrum Medyczne Śląskiej Akademii Medycznej

    Katowice, 40-635

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie

    Krakow, 31-202

  • Biegański Hospital

    Lodz, 91-347

Other trials in Poland

Spain4 sites

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Clinico Universitario Virgen de la Victoria - Campus de Teatinos s/n

    Málaga, 29010

Other trials in Spain

Bulgaria3 sites

  • City Clinic Cardiology Center Multiprofile Hospital for Active Treatment

    Sofia, 1407

  • Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

    Sofia, 1407

  • University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD

    Sofia, 1431

Other trials in Bulgaria

Italy2 sites

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • AOUI Verona - Borgo Trento Hospital

    Verona, 37126

Other trials in Italy

Switzerland1 site

  • Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

About this study

Official title: Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure.

Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.

Conditions
Heart Failure
Being tested
Injection of C3BS-CQR-1, Sham, no injection
Keywords
Chronic Heart Failure of Ischemic Origin
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection of C3BS-CQR-1Biological

    Injection of the C3BS-CQR-1 using the C-Cath® injection catheter.

  • Sham, no injectionBiological

    Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed

Study groups in NCT01768702
Study groupRoleWhat they receive
ControlSham comparatorSham, no injection
Receives: Biological: Sham, no injection
C3BS-CQR-1 TreatedExperimentalInjection of C3BS-CQR-1
Receives: Biological: Injection of C3BS-CQR-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy between groups post-index procedure

    Change between groups from baseline and 39 weeks in a hierarchical composite outcome comprising, from most to least severe outcome, days to death from any cause, number of worsening of heart failure events, change in score for the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (10-point deterioration, no meaningful change,10-point improvement), change in six-minute walk distance (40-m deterioration, no meaningful change, 40-m improvement) and change in left ventricular end systolic volume (15-mL deterioration, no meaningful change, 15-mL improvement), and left ventricular ejection fraction (4% absolute deterioration, no meaningful change, 4% absolute improvement).

    Measured: 39 weeks post-index

Secondary outcomes (1)

  1. Efficacy and safety between groups post-index procedure

    Safety: Number and cause of deaths and re-admissions, number of cardiac transplantations, number of myocardial infarctions, number of strokes. Incidence of serious adverse events (AE) through week 104 and non-serious AEs (through week 52).

    Efficacy: Time to all cause mortality, time to worsening of heart failure, and time to aborted sudden death through week 52.

    Measured: 52 and 104 weeks post-index

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01768702
Sponsor's protocol ID
C3BS-C-11-01
Other IDs
2011-001117-13
Acronym
CHART-1
Status last verified
May 2018
First submitted
21 Dec 2012
Last updated
1 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Bartunek J, Davison B, Sherman W, Povsic T, Henry TD, Gersh B, Metra M, Filippatos G, Hajjar R, Behfar A, Homsy C, Cotter G, Wijns W, Tendera M, Terzic A. Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design. Eur J Heart Fail. 2016 Feb;18(2):160-8. doi: 10.1002/ejhf.434. Epub 2015 Dec 14.

    PubMed 26662998

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Injection of C3BS-CQR-1 in people with Heart Failure, run by Celyad Oncology SA at 35 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Serbia, Belgium, Hungary, Israel, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy between groups post-index procedure (time frame: 39 weeks post-index). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01768702, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.

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