- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033278
Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Multicenter Phase IIb Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study population correspond to male and female patients with idiopathic dilated cardiomyopathy.
51 patients diagnosed with this disease are included. After inclusion, will proceed to the random allocation to study group or control group in a 2:1 ratio, 34 patients in the treatment group and 17 in the control group.
The total duration is expected to be 48 months: The inclusion period is 24 months and each patient assigned to the experimental group will be followed for 24 months, whereas that one ramdomized to the control group, will have a folow-up of 12 months. Upon completion there of, the patients will be followed in routine clinical practice.
This is a double blind study, in which all patients will perform the bone marrow harvesting.
All patients will receive the best medical treatment individualized (ACEIs or Angiotensin II receptor blocker, beta-blockers, diuretics and eplerenone) for at least 6 months prior to their participation in the clinical trial, so that the situation is stable and pharmacological basal condition is the same for everyone.
The bone marrow cells of patients assigned to placebo group will be cryopreserved, and once the trial is completed, the blind will be opened and all the patients who had been randomized to the control group, may be processed by the route of compassionate use with their own mononuclear bone marrow cells previously frozen.
The patients who are randomized to experimental group will be treated by the conventional treatment + infusion of autologous mononuclear bone marrow cells not expanded whereas the patients who are randomized to control group will be treated by the conventional treatment + infusion of placebo.
The main objective is to assess comparative the efficacy of intracoronary injection of bone marrow stem cells autologous to improve ventricular function in patients with idiopathic dilated cardiomyopathy who receive conventional medical treatment, compared with a control group who receive a infusion of placebo and conventional medical treatment. The improvement in ventricular function assessed by changes in angiographically determined ejection fraction.
Secondary objectives of the study are:
- To analyze the predictors of good clinical response, functional and biological treatment with adult stem cells autologous mononuclear bone marrow not expanded in terms of functional recovery.
The following parameters were evaluated: Functional class (NYHA), Natriuretic peptide B, Stress test (exercise time), Echocardiographic parameters of ventricular function, for example LVEF (%), TDV (ml), TSV (ml) and TAPSE (ms) and Biological parameters of cellular functionality, for example CD133 +, CD34 +, CD34 +/CD177 + and CD34 +/CD38- (in %).
- To determine, in the light of the obtained results, the application protocol suitable cell therapy for the treatment of dilated cardiomyopathy.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Cádiz, Spain
- Hospital Universitario Puerta del Mar
-
Córdoba, Spain
- Hopistal Universitario Reina Sofía
-
Granada, Spain
- Hospital Universitario Virgen de las Nieves
-
Huelva, Spain
- Hospital Universitario Juan Ramon Jimenez
-
Jerez De La Frontera, Spain
- Hospital de Jerez
-
Marbella, Spain
- Hospital Costa del Sol
-
Málaga, Spain, 29014
- Hospital Regional U. Carlos Haya
-
Sevilla, Spain
- Hospital Universitario Virgen Del Rocio
-
Sevilla, Spain
- Hospital Universitario Virgen Macarena
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of both sexes and ages between 18 and 70 years.
- Patients diagnosed with dilated cardiomyopathy established by echocardiography.
- Minimum evolution since diagnosis of 6 months.
- Absence of coronary injury tested with multislice CT and/or hemodynamic study performed after study entry, or within the previous 36 months (or before in specific low risk clinical profiles) if no angina symptomatology is present.
- Patients receiving optimized medical therapy for at least 6 months prior to enrollment (individually adjusted according to functional status).
- Ejection fraction of the left ventricle <40% or ejection fraction of the left ventricle 40% -50% if left ventricular tele-diastolic volume is > 110 ml/m2.
- Presence of sinus rhythm.
- Writen informed consent for participation in the trial.
- Normal laboratory parameters, defined by: Leukocytes ≥ 3000; Neutrophils ≥ 1500; Platelets ≥ 100,000; Aspartate aminotransferase / Alanine aminotransferase ≤ 2.5 standard range institution; Creatinine ≤ 2.5 mg / dL; Haemoglobin > 9 g/dL
- Women of childbearing potential must have negative results on a pregnancy test and agree to use medically approved methods of contraception thoughout follow up.
Exclusion Criteria:
- Secondary Dilated cardiomyopathy.
- Recent history of myocarditis (< 6 months prior to study entry).
- Patients amenable to receive cardiac resynchronization therapy
- Patients in active waiting list for heart transplantation.
- Coexistence of other serious systemic diseases.
- Coexistence of any type of blood disease
- Pregnant or breastfeeding women; or women of childbearing potential not comminting to use effective contraception.
- Patients who are currently participating, or have completed their participation in a clinical trial within the last 3 months. Patients who have participated in any advanced therapies clinical trial any time previously.
- Patients with malignant or pre-malignant tumors.
- Positive serology for hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
- Use of any protocolo prohibited medication. A wash-out period of 2 months can be considered for inclusion in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infusion of autologous mononuclear bone marrow cells
Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)
|
Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)
|
Placebo Comparator: Placebo infusion
Placebo infusion plus conventional medical treatment (as indicated by clinician)
|
Placebo infusion plus conventional medical treatment (as indicated by clinician)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in ventricular function measured angiographically.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up.
Time Frame: 24 months
|
24 months
|
Clinical and analytical progress (NYHA grade & BNP)
Time Frame: 24 months
|
24 months
|
Time of evolution since diagnosis of idiopathic dilated cardiomyopathy prior to study entry.
Time Frame: 24 months
|
24 months
|
Functional recovery as measured with ergometry
Time Frame: 24 months
|
24 months
|
Echocardiography and Electrocardiography variables
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Miguel Romero Moreno, MD, PhD, Hospital Universitario Reina Sofia
- Principal Investigator: Manuel Sobrino Marquez, MD, Hospitales Universitarios Virgen del Rocío
- Principal Investigator: Luis A Iñigo García, MD, Hospital Costa del Sol
- Principal Investigator: Ricardo Zayas Rueda, MD, Hospital Universitario Puerta del Mar
- Principal Investigator: Manuel De Mora Martín, MD, PhD, Hospital Regional U. Carlos Haya
- Principal Investigator: Silvia López Fernández, MD, University Hospital Virgen de las Nieves
- Principal Investigator: José Francisco Díaz Fernández, MD, Hospital Universitario Juan Ramon Jimenez
- Principal Investigator: Jesús Oneto Otero, MD, Hospital de Jerez
- Principal Investigator: Rafael Ruiz Salmerón, MD, Hospital Universitario Virgen Macarena
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMMo/MD/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Dilated Cardiomyopathy
-
Hospital General Universitario Gregorio MarañonMinisterio de Sanidad, Servicios Sociales e IgualdadUnknownPrimary Idiopathic Dilated CardiomyopathySpain
-
Nantes University HospitalCompleted
-
IRCCS SYNLAB SDNCompletedPatients With Ischemic or Idiopathic Dilated CardiomyopathyItaly
-
Ray HershbergerNational Heart, Lung, and Blood Institute (NHLBI); National Human Genome Research...Active, not recruiting
-
University of TehranCompletedDilated CardiomyopathyIran, Islamic Republic of
-
Qingdao UniversityUnknownDilated CardiomyopathyChina
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); GlaxoSmithKline; AstraZenecaCompletedIdiopathic Dilated CardiomyopathyUnited States
-
mamdouh abdulmaksoud abdulrhmanCompletedIdiopathic Dilated Cardiomyopathy
-
Azienda Ospedaliera Universitaria Integrata VeronaAbbott Medical DevicesRecruitingHeart Failure | Left Ventricular Dysfunction | Idiopathic Dilated CardiomyopathyItaly
-
Stanford UniversityTerminatedDilated CardiomyopathyUnited States
Clinical Trials on Infusion of autologous mononuclear bone marrow cells
-
Federal University of BahiaOswaldo Cruz FoundationUnknownSickle Cell Disease | Chronic Leg Ulcer
-
Xijing HospitalUnknownMyocardial InfarctionChina
-
Andalusian Initiative for Advanced Therapies -...Iniciativa Andaluza en Terapias AvanzadasCompletedCritical Limb Ischemia (CLI)Spain
-
The University of Texas Health Science Center,...National Institute of Neurological Disorders and Stroke (NINDS)CompletedTraumatic Brain InjuryUnited States
-
CellPraxis Bioengenharia Ltda.University of South Florida; Federal University of São Paulo; Cryopraxis Criobiologia...Completed
-
TotipotentSC Scientific Product Pvt. Ltd.Thermogenesis Corp.CompletedCritical Limb IschemiaIndia
-
Universidade Federal do Rio de JaneiroCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Oswaldo Cruz... and other collaboratorsUnknownLiver Cirrhosis Due to Virus C Chronic HepatitisBrazil
-
Andalusian Network for Design and Translation of...Carlos III Health InstituteCompletedDiabetic Foot | Peripheral Vascular DiseasesSpain
-
Vinmec Healthcare SystemCompleted