Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial)

NCT02059681 | Completed Phase 1

• 1 other identifier: S225/612
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is 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.

Conditions

Chronic Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  1 year

Secondary Outcomes (1)

• Efficacy

  6 months

Study Arms (1)

Autologous bone marrow derived-CD133+ cells

EXPERIMENTAL

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

Interventions

Autologous bone marrow derived-CD133+ cells OTHER

Cell therapy

Autologous bone marrow derived-CD133+ cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic heart failure not amenable to any type of revascularization procedure (percutaneous or surgical) as determined by one interventional cardiologist and one cardiovascular surgeon,
• Canadian Cardiovascular Society Angina functional class III to IV angina and/or symptoms of heart failure (NYHA score IIb to IV) under state-of-the-art maximal medical therapy,
• Left Ventricular Ejection Fraction between 20% and 45%,
• Peak V02 ≤ 21 mL/Kg/min,
• Presence of a reversible perfusion defect ≥ 10% of the left ventricular myocardium (at least 2 segments over 20) as determined by gated-SPECT, 6.18 years ≤ Age ≤ 75 years,
• Hemodynamic stability, 8.Ability to accomplish a cardiopulmonary exercise testing, 9.Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before intervention and must be using oral or injectable contraception (non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start), 10.A signed consent form that has been approved by the institutional review board.

You may not qualify if:

• A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the past 3 months,
• Presence of a documented unstable angina,
• Left ventricular thrombus, as documented by echocardiography,
• Evidence of a life-threatening arrhythmia,
• Presence of any severe mitral valve disease requiring valve replacement or reconstruction,
• Presence of a mechanical aortic valve,
• Presence of stenosis of the aortic valve, graded as ≥+2 equivalent to an orifice area of 1,5 cm2 or less,
• Presence of moderate to severe insufficiency of the aortic valve,
• A left ventricular wall thickness of \<8 mm at the target site for cell injection, as assessed by 2-D echocardiography and/or cardiac MRI,
• Have a known, serious radiographic contrast allergy,
• Contraindications to bone-marrow aspiration,
• Be an organ transplant recipient,
• Have liver dysfunction, as evidenced by enzymes (AST,ALT) \>3x the upper limits of normals,
• Severe renal failure (creatinine plasma levels \> 2.5 mg/dl),
• A bleeding diathesis (defined as an INR greater than 1,5 not because of a reversible cause, i.e. warfarin),

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• A.O.U. Città della Salute e della Scienza: collaborator
• Azienda Ospedaliera San Gerardo di Monza: collaborator

Study Sites (3)

Azienda Ospedaliera San Gerardo di Monza

Monza, MB, 20900, Italy

Location

Centro Cardiologico Monzino, IRCCS

Milan, MI, 20138, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

Location

Related Publications (1)

• Bassetti B, Carbucicchio C, Catto V, Gambini E, Rurali E, Bestetti A, Gaipa G, Belotti D, Celeste F, Parma M, Righetti S, Biava L, Arosio M, Bonomi A, Agostoni P, Scacciatella P, Achilli F, Pompilio G. Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived CD133+ cells in ischemic refractory cardiomyopathy trial (RECARDIO). Stem Cell Res Ther. 2018 Sep 14;9(1):235. doi: 10.1186/s13287-018-0969-z.

  PMID: 30217223 DERIVED

Study Officials

• Giulio Pompilio, MD PhD

  Centro Cardiologico Monzino, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

IT (3)