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

NCT01768702 | Completed Phase 3 DMC

• 2 other identifiers: C3BS-C-11-012011-001117-13
• Study Type: interventional
• Target: 315
• Locations: 9 countries
• Sites: 35

Brief 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.

Conditions

Heart Failure

Keywords

Chronic Heart Failure of Ischemic Origin

Outcome Measures

Primary Outcomes (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).

  39 weeks post-index

Secondary Outcomes (1)

• Efficacy and safety between groups post-index procedure

  52 and 104 weeks post-index

Other Outcomes (1)

• Efficacy and safety between groups post-index procedure

  39 and 52 weeks post-index

Study Arms (2)

Control

SHAM COMPARATOR

Sham, no injection

Biological: Sham, no injection

C3BS-CQR-1 Treated

EXPERIMENTAL

Injection of C3BS-CQR-1

Biological: Injection of C3BS-CQR-1

Interventions

Injection of C3BS-CQR-1 BIOLOGICAL

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

C3BS-CQR-1 Treated

Sham, no injection BIOLOGICAL

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Celyad Oncology SA: lead

Study Sites (35)

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Hopital Civil Marie Curie

Lodelinsart, 6042, Belgium

Location

AZ Glorieux

Ronse, 9600, Belgium

Location

CHU Mont-Godinne

Yvoir, 5530, Belgium

Location

City Clinic Cardiology Center Multiprofile Hospital for Active Treatment

Sofia, 1407, Bulgaria

Location

Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Sofia, 1407, Bulgaria

Location

University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD

Sofia, 1431, Bulgaria

Location

Gottsegen György Országos Kardiológiai Intézet - Felnőtt Kardiológiai Osztály

Budapest, 1096, Hungary

Location

Semmelweis Egyetem - Városmajori Szív- és Érgyógyászati Klinika

Budapest, 1122, Hungary

Location

MH Egészségügyi Központ Kardiológiai Osztály

Budapest, 1134, Hungary

Location

Debreceni Egyetem Orvos - és Egészségtudomanyi Centrum

Debrecen, 4032, Hungary

Location

Pécsi Tudományegyetem Klinikai Központ - Szívgyógyászati Klinika

Pécs, 7624, Hungary

Location

Barzilai Medical Center - Cardiology Unit

Ashkelon, 78278, Israel

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Western Galilee Hospital

Nahariya, Israel

Location

Nazareth Hospital EMMS

Nazareth, 16100, Israel

Location

Ziv Medical Center - Heart Institute

Safed, 13110, Israel

Location

A.O. Spedali Civili di Brescia

Brescia, 25123, Italy

Location

AOUI Verona - Borgo Trento Hospital

Verona, 37126, Italy

Location

Uniwersyteckie Centrum Kliniczne, KliniczneCentrum Kardiologii

Gdansk, 80-126, Poland

Location

Górnośląskie Centrum Medyczne Śląskiej Akademii Medycznej

Katowice, 40-635, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie

Krakow, 31-202, Poland

Location

Biegański Hospital

Lodz, 91-347, Poland

Location

Clinic of Emergency Internal Medicinne Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia - Cardiology Clinic

Belgrade, 11000, Serbia

Location

Clinical Centre of Serbia, Cardiology Clinic

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Zvezdara - Cardiology Clinic

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa, Cardiology Dept.

Belgrade, 11080, Serbia

Location

Clinical Center of Kragujevac,

Kragujevac, 34 000, Serbia

Location

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

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

Málaga, 29010, Spain

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 26662998 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• André Terzic, MD

  Mayo Clinic, Division of Cardiovascular Diseases, Rochester (MN, USA)

  STUDY CHAIR

• Jozef Bartunek, MD

  OLV Ziekenhuis Aalst (Belgium)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 15, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

ES (4); SE (6); CH (1); HU (5); BU (3); PL (4); IL (5); BE (5); IT (2)