Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy

NCT01957826 | Unknown Phase 1

• 3 other identifiers: FIBHGM-ECNC017-20102010-024406-35MIYOCYTE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety, the feasibility and the efficacy of transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients with dilated idiopathic cardiomyopathy.

Conditions

Primary Idiopathic Dilated Cardiomyopathy

Keywords

mesenchymal; stem cells; transendocardial injection; dilated idiopathic cardiomyopathy; idiopathic cardiomyopathy

Outcome Measures

Primary Outcomes (4)

• Major adverse cardiac adverse events. SAEs and AEs.

  Major adverse cardiac adverse events includes cerebral adverse events

  change from enrollment( 1, 3, 6, 12, 18 and 24 months)

• NYHA functional class.

  Change from enrolment( 1, 3, 6, 12, 18, 24 months)

• Incidence of complications with the use of NOGA XPTM catheters.

  Change from enrolment( 1, 3, 6, 12, 18, 24 months)

• Laboratory parameters including C-reactive protein an brain natriuretic peptide

  Change from enrolment( 1, 3, 6, 12, 18, 24 months)

Secondary Outcomes (6)

• NYHA Functional Class

  1, 3, 6, 12, 18, 24 months

• Max.oxygen consumption(MVO2),functional capacity.

  6,12,24 months

• Quality of life questionnaires

  6,12 and 24 months

• Extension. of perfusion defects(MRI/SPECT).

  6 and 24 months

• LVEF, ventricular vol.,wall motion score index(echocard./MRI/SPECT

  6,12 and 24 months

Study Arms (2)

placebo comparator

PLACEBO COMPARATOR

transendocardial injection of placebo solution

Other: placebo intervention

bone marrow-derived MSCs injection

EXPERIMENTAL

transendocardial injection of 30-40 million bone marrow-derived MSCs with the NOGA XPTM platform. 15 injections in the anterior wall of the left ventricle.

Other: bone marrow-derived MSCs injection

Interventions

bone marrow-derived MSCs injection OTHER

transendocardial injection of 30-40 million bone marrow-derived MSCs with the NOGA XPTM platform. 15 injections in the anterior wall of the left ventricle.

bone marrow-derived MSCs injection

placebo intervention OTHER

placebo administration

placebo comparator

Eligibility Criteria

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

You may qualify if:

• II-III NYHA functional class, under optimal medical therapy.
• LVEF ≥ 20% and ≤ 45% by echocardiography, SPECT or left ventriculogram one month prior to enrollment.
• Anterior wall thickness ≥ 8 mm by echocardiography or MRI one month prior to enrollment.
• Idiopathic DCM diagnosis (having excluded CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases) six months prior to enrollment.
• Able to exercise on a treadmill, MVO2 between ≥ 12 and ≤ 21 ml/Kg/min.
• Hemodynamic stability (blood pressure \> 100/40 mmHg, heart rate \< 110 bpm and oxygen saturation \> 95%).
• Negative pregnancy test in women.
• Signed informed consent

You may not qualify if:

• Evidence of secondary dilated cardiomyopathy causes: CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases, myocarditis or postpartum ventricular dysfunction.
• Permanent atrial fibrillation.
• Candidates for heart transplantation if surgery is anticipated in the next 2 years.
• Left ventricular thrombus by echocardiography, MRI or left ventriculogram.
• Peripheral artery disease that precludes cardiac catheterization with 8 Fr sheaths. .
• Anterior wall thickness \< 8 mm by echocardiography or MRI one month prior to enrollment.
• Chronic renal failure (creatinine \> 2,5 mg/dL).
• I or IV NYHA functional class. Cardiogenic shock is defined as systolic blood pressure \< 90 mmHg with no response to fluids, or \< 100 mmHg with inotropes and without bradycardia.
• Previous history of drug abuse (alcohol, etc…).
• Acute or chronic infectious disease (including B/C hepatitis and HIV).
• Pregnancy or child-bearing period.
• MRI contraindications: pacemakers, ICD, metalic prosthesis, etc.
• Bleeding or coagulation disorders (INR \> 2 without anticoagulation treatment).
• Cancer history 5 years prior to enrollment.
• Life expectancy less than 1 year.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (2)

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Clinico Universitario de Valladolid

Valladolid, Valladolid, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathies

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Francisco Fernandez Aviles, PhD

  Hospital General Universitario Gregorio Marañón

  STUDY CHAIR

Central Study Contacts

Ricardo Sanz, MD

CONTACT

034 91 426 5882; rsanzruiz@hotmail.com

Francisco Fernandez Avilés, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: October 8, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

ES (2)