Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial) (RECARDIO)
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|ClinicalTrials.gov Identifier: NCT02059681|
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myocardial Ischemia||Other: Autologous bone marrow derived-CD133+ cells||Phase 1|
This will be a Phase I study investigating the safety and preliminary efficacy of endocavitary injection of bone-marrow-derived CD133+ cells in 15 patients with ischemic heart failure (IHF) not eligible for conventional revascularization. Patients eligible will undergo bone-marrow aspiration. On the day following bone-marrow aspiration patients will undergo fluoroscopy-based endocavitary intramyocardial injections of the target areas previously identified by gated-SPECT/CMR. CD133+ cells suspended in physiological saline supplemented with 5% human albumin solution will be injected into the myocardium via the endocardial route.
After discharge, efficacy follow-up will last 6-months safety follow-up (FU) will be extended up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial)|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Autologous bone marrow derived-CD133+ cells
CD133+ cells (1-12x10^6) suspended in 10 ml physiological saline supplemented with 5% human albumin solution will be injected into the myocardium via the endocardial route; the whole 10 ml solution will be divided into 15-20 injections.
Other: Autologous bone marrow derived-CD133+ cells
- Safety [ Time Frame: 1 year ]The primary objective of this study will be to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment.
- Efficacy [ Time Frame: 6 months ]To determine the effects of autologous CD133+ cells as assessed before and 6-months after injection on a) regional myocardial perfusion on the basis of stress gated-SPECT and CMR when available; b) functional capacity on the basis of peak VO2 consumption at CPET.
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): NCT02059681
|Contact: Giulio Pompilio, MD PhD||+39 02 firstname.lastname@example.org|
|Contact: Beatrice Bassetti, MSc||+39 02 email@example.com|
|Azienda Ospedaliera San Gerardo di Monza||Recruiting|
|Monza, MB, Italy, 20900|
|Contact: Felice Achilli, MD|
|Principal Investigator: Felice Achilli, MD|
|Centro Cardiologico Monzino, IRCCS||Recruiting|
|Milano, MI, Italy, 20138|
|Contact: Giulio Pompilio, MD PhD +39 02 58002562 firstname.lastname@example.org|
|Contact: Corrado Carbucicchio, MD +39 02 58002616 email@example.com|
|Principal Investigator: Giulio Pompilio, MD PhD|
|Azienda Ospedaliera Città della Salute e della Scienza di Torino||Recruiting|
|Torino, TO, Italy, 10126|
|Contact: Sebastiano Marra, MD|
|Principal Investigator: Sebastiano Marra, MD|
|Principal Investigator:||Giulio Pompilio, MD PhD||Centro Cardiologico Monzino, IRCCS|