Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
NCT ID: NCT01508910
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
291 participants
INTERVENTIONAL
2012-04-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Arm
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
Active Control Arm
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
Placebo: Diluent used to suspend Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of placebo
Unblinded Standard of Care (SOC) Arm
No study-related procedures will be performed.
Standard of care
Standard of care for refractory angina
Interventions
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Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
Placebo: Diluent used to suspend Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of placebo
Standard of care
Standard of care for refractory angina
Eligibility Criteria
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Inclusion Criteria
* Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
* Participants without control of their angina symptoms in spite of maximal tolerated doses of anti-angina drugs. Participants must be on optimal therapy for their angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form.
* Participants with obstructive coronary disease unsuitable for conventional revascularization due to unsuitable anatomy or comorbidity as determined at the site and confirmed by an independent adjudication committee.
* Participants must have evidence of inducible myocardial ischemia.
* Participants must experience angina episodes.
* Participants must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization.
* If female of childbearing potential, subject must not be pregnant and agree to employ adequate birth control measures for the duration of the study.
Exclusion Criteria
* Participant has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment.
* Participant has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment.
* Participant has a history of moderate to severe aortic stenosis; or severe aortic insufficiency; or severe mitral stenosis; or severe mitral insufficiency.
* Participant has a prosthetic aortic valve or a mechanical mitral valve replacement.
* Participant has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses.
* Participants with cancer are excluded with the following exceptions:
* Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not excluded.
* Participants that have been cancer free for \>= 5 years as determined by their oncologist are not excluded. Subjects with a prior history of stem cell transplant for cancer are excluded no matter how long they have been cancer-free.
* Participants with a history of leukemia or other bone marrow disease.
* Participant has sickle cell disease or sickle cell trait.
* Participants with proliferative retinopathy.
* Participants with Hb A1c \> 9%.
* Participant has platelet counts \>10% above the upper limit of normal (ULN) or platelet counts \< 70,000.
* Participant has a hematocrit \< 30% prior to potential study enrollment.
* Participant has a serum creatinine \> 2.5 mg/dL prior to potential study enrollment.
* Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant.
* Participant has a known contraindication to Neupogen (filgrastim) or G-CSF.
* Participant was previously enrolled in an active treatment group of cell therapy trials for cardiovascular disease including any phase of CD34+ stem cell trials.
* Left ventricular (LV) thickness of \< 7 mm in the target areas of injection as measured by during a 2-D echocardiogram (ECHO).
* Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection.
* Bleeding diathesis with an INR \> 1.8 when not receiving anti-thrombotic therapy.
* Hepatic dysfunction as evidenced by elevated AST or ALT levels \> 2.5 x ULN.
* Any previous transplant requiring immunosuppression.
* Disease state requiring chronic immunosuppression.
21 Years
80 Years
ALL
No
Sponsors
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Lisata Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Caladrius Study Director
Role: STUDY_DIRECTOR
Caladrius Biosciences
Locations
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Birmingham, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Oxnard, California, United States
San Diego, California, United States
Stanford, California, United States
Boynton Beach, Florida, United States
Daytona Beach, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Saginaw, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Haddon Heights, New Jersey, United States
Newark, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Povsic TJ, Henry TD, Traverse JH, Fortuin FD, Schaer GL, Kereiakes DJ, Schatz RA, Zeiher AM, White CJ, Stewart DJ, Jolicoeur EM, Bass T, Henderson DA, Dignacco P, Gu Z, Al-Khalidi HR, Junge C, Nada A, Hunt AS, Losordo DW; RENEW Investigators. The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1576-85. doi: 10.1016/j.jcin.2016.05.003.
Povsic TJ, Junge C, Nada A, Schatz RA, Harrington RA, Davidson CJ, Fortuin FD, Kereiakes DJ, Mendelsohn FO, Sherman W, Schaer GL, White CJ, Stewart D, Story K, Losordo DW, Henry TD. A phase 3, randomized, double-blinded, active-controlled, unblinded standard of care study assessing the efficacy and safety of intramyocardial autologous CD34+ cell administration in patients with refractory angina: design of the RENEW study. Am Heart J. 2013 Jun;165(6):854-861.e2. doi: 10.1016/j.ahj.2013.03.003. Epub 2013 Apr 19.
Other Identifiers
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RENEW Study
Identifier Type: OTHER
Identifier Source: secondary_id
901001
Identifier Type: -
Identifier Source: org_study_id