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Chronic Myocardial IschemiaPhase 1RECARDIONCT02059681

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

A Phase 1 study testing Autologous bone marrow derived-CD133+ cells in people with Chronic Myocardial Ischemia, run by Centro Cardiologico Monzino at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Myocardial Ischemia
What is being tested?
Autologous bone marrow derived-CD133+ cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesItaly
Study dates
Dec 2013to Feb 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
  • 7.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.

Who cannot join

  • 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,
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  • 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),
  • Have an hematologic abnormality without other explanation,
  • Apparent infection (c-reactive protein (CPR)>30 mg/L, fever > 37 °C),
  • An infectious-disease test result positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, treponema pallidum (VDRL), HTLV 1 and 2,
  • Previous or current documented history of leukemia, myeloproliferative or myeloplastic disorders,
  • Have a cardiac condition that limits lifespan to <1 y,
  • A history of malignancy in the past 5 years,
  • Have a history of drug or alcoholic abuse within the past 24 months,
  • Be on chronic therapy with immunosuppressants,
  • Pregnant or lactating status,
  • Any condition that, in the judgment of the investigator, would place the patient at undue risk.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Centro Cardiologico Monzino, IRCCS

    Milan, MI, 20138

  • Azienda Ospedaliera San Gerardo di Monza

    Monza, MB, 20900

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, TO, 10126

Other trials in Italy

About this study

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.

Read the detailed description

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.

Being tested
Autologous bone marrow derived-CD133+ cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous bone marrow derived-CD133+ cellsOther

    Cell therapy

Study groups in NCT02059681
Study groupRoleWhat they receive
Autologous bone marrow derived-CD133+ cellsExperimentalCD133+ 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.
Receives: Other: Autologous bone marrow derived-CD133+ cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

  1. Efficacy

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2022
  4. Study completionFeb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059681
Sponsor's protocol ID
S225/612
Acronym
RECARDIO
Status last verified
Mar 2022
First submitted
7 Feb 2014
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30217223

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous bone marrow derived-CD133+ cells in people with Chronic Myocardial Ischemia, run by Centro Cardiologico Monzino at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059681, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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