- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00300053
ACT34-CMI -- Adult Autologous CD34+ Cells
8. Januar 2021 aktualisiert von: Lisata Therapeutics, Inc.
A DB, Randomized, Placebo-controlled Study of the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial CLBS14 for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)
The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor (G-CSF) for the reduction of angina episodes in patients with refractory chronic myocardial ischemia.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
321
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35211
- Cardiology PC
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85054
- Mayo Clinic Hospital
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Phoenix, Arizona, Vereinigte Staaten, 85005
- Arizona Heart Institute
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California
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La Jolla, California, Vereinigte Staaten, 92037
- Scripps Memorial Hospital
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Stanford, California, Vereinigte Staaten, 94305
- Stanford University Hospital and Clinics
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20010
- Washington Hospital Center
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Florida
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Fort Lauderdale, Florida, Vereinigte Staaten, 33308
- Holy Cross Hospital
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Gainesville, Florida, Vereinigte Staaten, 32610
- University of Florida Health Science Center
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Jacksonville, Florida, Vereinigte Staaten, 32209
- University of Florida Health Science Center
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Orlando, Florida, Vereinigte Staaten, 32803
- Central Florida Cardiology Group
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Saint Joseph's Research Institute
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Rush University Medical Center
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Chicago, Illinois, Vereinigte Staaten, 60611
- Northwestern University Medical Center, Bluhm Cardiovascluar Institute
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52242
- University of Iowa Hospitals & Clinic
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02135
- Caritas Saint Elizabeth's Medical Center
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Abbott Northwestern Hospital
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New York
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New York, New York, Vereinigte Staaten, 10032
- New York Presbyterian Hospital - Columbia University Medical Center
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New York, New York, Vereinigte Staaten, 10065
- New York Presbyterian Hospital - Weill Cornell Medical College of Cornell University
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45267
- University of Cincinnati Medical Center
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Cincinnati, Ohio, Vereinigte Staaten, 45219
- The Lindner Clinical Trial Center
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Cleveland, Ohio, Vereinigte Staaten, 44106
- University Hospitals Case Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University of Pittsburgh Medical Center
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Washington
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Seattle, Washington, Vereinigte Staaten, 98122
- Swedish Heart & Vascular - Swedish Medical Center
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53792
- University of Wisconsin Medical School
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Milwaukee, Wisconsin, Vereinigte Staaten, 53223
- Comprehensive Cardiovascular Care Group
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Canadian Cardiovascular Society (CCS) functional class III or IV chronic refractory angina
- subjects without control of their angina symptoms, in spite of maximal tolerated doses of anti-anginal drugs, must be on optimal therapy for their angina and on a stable anti-anginal medication regimen for at least 1 month prior to entering the screening period of the study
- identified as unsuitable for conventional revascularization
- recent coronary angiogram (within the last 12 months) to document the coronary anatomy and to verify the revascularization procedures
- subjects must have objective evidence of inducible ischemia or viable myocardium in the potential target injection zone
- a left ventricular ejection fraction equal to or greater than 25% by ECHO or single photon emission computed tomography (SPECT) at screening
- subjects must experience at minimum an average of 7 angina or anginal equivalent episodes per week
- subjects must be able to complete a minimum of 3 minutes but nor more than 10 minutes on a treadmill following the Modified Bruce Protocol
- subjects must experience angina or anginal equivalent episodes during the screening exercise treadmill test
- female subjects must either be no longer capable of reproduction or using medically valid contraception to prevent pregnancy during the study
- subjects must be willing and able to comply with specified follow-up evaluations
Exclusion Criteria:
- predominant congestive heart failure
- myocardial infarction within 60 days of treatment
- successful or partially successful coronary revascularization procedures (any vessel) within 6 months of study enrollment
- placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure in the past 90 days
- documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment
- history of moderate to severe aortic stenosis or severe aortic insufficiency; severe mitral stenosis or severe mitral insufficiency
- prosthetic aortic valve replacement
- evidence of any life-threatening arrhythmia that requires intervention on the 24-hour Holter monitor. Life-threatening arrhythmia that is successfully treated with an implantable cardioverter defibrillator (ICD) is not exclusionary.
- splenomegaly and/or severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (ie, severe chronic obstructive pulmonary disease, renal failure or cancer [exceptions: in-situ skin cancer or fully removed skin cancer other than melanoma, in-situ cervical cancer, or cancer free for 5 years with no history of a stem cell transplant])
- sickle cell disease or sickle cell trait
- platelet count greater than 10% above the upper limit of normal or a platelet count below 100,000 if on Clopidogrel or 50,000 without Clopidogrel
- hematocrit <30%
- serum creatinine >2.5 mg/dL
- any clinically significant laboratory abnormality on screening laboratories
- currently enrolled in another IDE or IND that has not completed the protocol required primary follow-up period (excludes 15 year follow up of gene therapy trials)
- history of alcohol or drug abuse within 3 months of screening
- joint or peripheral vascular disease or neurologic disease that severely limits treadmill walking
- chronic obstructive pulmonary disease that severely limits walking or FEV1 <30% predicted
- females who are pregnant or lactating
- female subjects who are capable of reproduction and will not use medically valid contraception to prevent pregnancy during the study
- subjects who test positive for HIV, hepatitis B or hepatitis C, or are on chronic immunosuppressive medications or have had a prior stem cell transplant
- subjects with a known hypersensitivity to E. coli-derived proteins, or to any component of Neupogen (Filgrastim) or G-CSF
- subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject´s ability to provide informed consent and/or comply with protocol procedures
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: CLBS14: Low-Dose Group
10 intramyocardial injections of 0.2 mL each of auto-CD34+ cells at a dose of 1 x 10^5 (=100000) cells/kg bodyweight
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Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood.
Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare).
Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 1 x 10^5 (=100000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.
Andere Namen:
|
Experimental: CLBS14: High-Dose Group
10 intramyocardial injections of 0.2 mL each of auto-CD34+ cells at a dose of 5 x 10^5 (=500000) cells/kg bodyweight
|
Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+cells from the bone marrow to the peripheral blood.
Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare).
Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 5 x 10^5 (=500000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.
Andere Namen:
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Placebo-Komparator: Placebo injection
10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma
|
Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood.
Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare).
Placebo will be delivered in 10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma into the target areas of myocardial ischemia.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Angina Episodes Per Week at 6 and 12 Months
Zeitfenster: 6 and 12 months
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The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months.
The four-week angina episodes (per week mean) were used as the frequency for each visit.
A lower number represents fewer angina episodes.
A lower number is better.
|
6 and 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise
Zeitfenster: Change from Baseline to 6 months and change from baseline to 12 months after treatment
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A modified Bruce Protocol Exercise Treadmill Test was used to evaluate duration of exercise in all subjects.
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Change from Baseline to 6 months and change from baseline to 12 months after treatment
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Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Zeitfenster: Baseline and 12 months after treatment
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The Canadian Cardiovascular Society (CCS) Functional Classification of Angina is as follows:
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Baseline and 12 months after treatment
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Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Zeitfenster: Baseline to 6 months after treatment
|
Angina symptoms were evaluated based on the Seattle Angina Questionnaire (SAQ), which was used to analyze the following: physical limitations, angina stability, angina frequency, treatment satisfaction, and disease perception.
The SAQ consisted of 11 questions with 5 or 6 possible responses.
Responses were ordinal values (1-7, 10, 11, 97, depending on the type of question; no uniform ranges throughout); responses that corresponded to the lowest level of functioning (worse outcomes) were assigned values of 1, while responses that corresponded to higher functioning levels (better outcome) were assigned a higher ordinal value.
If the response to any of these questions was 97 it was recoded as a missing value.
Each scale can have a scored value ranging from 0 to 100.
A larger number is better.
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Baseline to 6 months after treatment
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Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Zeitfenster: Baseline to 6 months after treatment
|
The Short Form 36 (SF-36) health survey form was used to analyze physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, general mental health, and health transition.
Responses were coded as ordinal numbers going from worst (=1) to best (=highest number).
These ordinal scores were transformed into scales ranging from 0 to 100.
Higher numbers are generally considered better.
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Baseline to 6 months after treatment
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Change in Anti-anginal Medication (ie, Nitroglycerin) Use
Zeitfenster: Baseline to 6 months
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The mean nitroglycerin use per week was analyzed at baseline and 6 months
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Baseline to 6 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Caladrius Study DIrector, Lisata Therapeutics, Inc.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Losordo DW, Henry TD, Davidson C, Sup Lee J, Costa MA, Bass T, Mendelsohn F, Fortuin FD, Pepine CJ, Traverse JH, Amrani D, Ewenstein BM, Riedel N, Story K, Barker K, Povsic TJ, Harrington RA, Schatz RA; ACT34-CMI Investigators. Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res. 2011 Aug 5;109(4):428-36. doi: 10.1161/CIRCRESAHA.111.245993. Epub 2011 Jul 7.
- Henry TD, Schaer GL, Traverse JH, Povsic TJ, Davidson C, Lee JS, Costa MA, Bass T, Mendelsohn F, Fortuin FD, Pepine CJ, Patel AN, Riedel N, Junge C, Hunt A, Kereiakes DJ, White C, Harrington RA, Schatz RA, Losordo DW; ACT. Autologous CD34+ Cell Therapy for Refractory Angina: 2-Year Outcomes From the ACT34-CMI Study. Cell Transplant. 2016;25(9):1701-1711. doi: 10.3727/096368916X691484. Epub 2016 May 4.
- Povsic TJ, Losordo DW, Story K, Junge CE, Schatz RA, Harrington RA, Henry TD. Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI. Am Heart J. 2012 Nov;164(5):689-697.e3. doi: 10.1016/j.ahj.2012.06.022.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2006
Primärer Abschluss (Tatsächlich)
1. März 2008
Studienabschluss (Tatsächlich)
1. März 2009
Studienanmeldedaten
Zuerst eingereicht
6. März 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. März 2006
Zuerst gepostet (Schätzen)
8. März 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Januar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Januar 2021
Zuletzt verifiziert
1. Januar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Herzkrankheiten
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Koronare Krankheit
- Koronare Herzkrankheit
- Myokardischämie
- Ischämie
- Physiologische Wirkungen von Arzneimitteln
- Immunologische Faktoren
- Adjuvantien, Immunologische
- Lenograstim
Andere Studien-ID-Nummern
- 24779
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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