Intramyocardial Delivery of Autologous Bone Marrow

NCT00820586 | Suspended Phase 2

• 1 other identifier: TVICPR-003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells in patients with refractory angina pectoris.

Conditions

Refractory Angina

Keywords

Intramyocardial; Autologous; Bone; Marrow; Randomized; Percutaneous; CD34+; Refractory; Angina; Pectoris.

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse cardiac events (MACE), defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures and peri-procedural complications.

  1, 6, 12 months

Secondary Outcomes (7)

• Change in Canadian Cardiovascular Society (CCS) angina classification score

  12 months

• Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire

  1,3,6,12 months and every year for 8 years

• Change in exercise duration and exercise tolerance using standardized treadmill exercise testing

  6,12 months

• Cumulative number of hospitalizations for coronary ischemia and congestive heart failure

  12 months

• SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution

  1, 6, 12 months

Study Arms (2)

Mononuclear bone marrow derived cells

EXPERIMENTAL

Intramyocardial injection of total mononuclear bone marrow derived cells

Procedure: Mononuclear bone marrow derived cells

Selected CD34+ bone marrow derived cells

EXPERIMENTAL

Intramyocardial injection of selected CD34+ bone marrow derived cells

Procedure: Mononuclear bone marrow derived cells

Interventions

Mononuclear bone marrow derived cells PROCEDURE

Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells

Also known as: Selected CD34+ bone marrow derived cells

Mononuclear bone marrow derived cells; Selected CD34+ bone marrow derived cells

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects \>21 years old;
• Subjects with functional class (CCS) III or IV angina;
• Subjects with left ventricular (LV) ejection fraction ³ 30%
• Attempted "best" tolerated medical therapy
• Clinical signs and symptoms of myocardial ischemia with reversible ischemia on perfusion imaging;
• Patient deemed to be a poor candidate or at high surgical risk;
• Subject must be able to complete a minimum of 2 minutes but no more than 10 minutes exercise test (Bruce Protocol);
• Subject (or their legal guardian) understands the nature of the procedure and provides written consent prior to the procedure;
• Subject is willing to comply with specified follow-up evaluations;
• Patient must develop angina and a horizontal or down-sloping ST-segment depression of ³ 1 mm during exercise, compared to pre-exercise ST segment, 80 ms from the J point or moderate angina with or without the above ST segment changes.
• Severe obstruction (lumen diameter stenosis \> 70%) in a coronary or surgical conduit felt to be solely or partially responsible for angina and myocardial ischemia;
• There must be at least one coronary or surgical conduit with \< 70% diameter stenosis
• Poor candidate for percutaneous coronary intervention of treatment zone
• Poor candidates for surgical revascularization procedures, such as inadequate target coronary anatomy or lack of potential surgical conduits.

You may not qualify if:

• Pregnant women;
• Left ventricular ejection fraction \<30% as assessed by either echocardiography or left ventriculography;
• Severe cardiac heart failure with NYHA functional class III-IV symptoms;
• Chronic atrial fibrillation;
• Prosthetic aortic valve;
• Severe (grade III-IV) mitral or aortic insufficiency;
• Wall thickness of \<8 mm (defined by echocardiography) of the proposed target region of myocardium;
• Severe co-morbidity associated with a reduction in life expectancy of \<1 year, such as chronic medical illnesses
• Braunwald class II unstable angina
• Severe peripheral (or aortic) vascular disease which might increase the risk of vascular complications (perforation, dissection or embolization);
• Significant aortic valve pathologic sclerosis or stenosis
• LV thrombus (mobile or mural-based) seen on echocardiography;
• Recent (within 4 weeks) documented myocardial infarction (Q and/or non-Q wave) defined as CK-MB \>3times upper normal level;
• Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period;
• Thrombocytopenia or history of heparin-induced thrombocytopenia or thrombocytosis

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS S. Raffaele

Milan, 20132, Italy

Location

Related Publications (35)

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  PMID: 16990385 RESULT

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Invasive Cardiology Unit

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: May 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2018
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

IT (1)