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ACT34-CMI -- Adult Autologous CD34+ Cells

8. ledna 2021 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

321

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35211
        • Cardiology PC
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85054
        • Mayo Clinic Hospital
      • Phoenix, Arizona, Spojené státy, 85005
        • Arizona Heart Institute
    • California
      • La Jolla, California, Spojené státy, 92037
        • Scripps Memorial Hospital
      • Stanford, California, Spojené státy, 94305
        • Stanford University Hospital and Clinics
    • District of Columbia
      • Washington, District of Columbia, Spojené státy, 20010
        • Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, Spojené státy, 33308
        • Holy Cross Hospital
      • Gainesville, Florida, Spojené státy, 32610
        • University of Florida Health Science Center
      • Jacksonville, Florida, Spojené státy, 32209
        • University of Florida Health Science Center
      • Orlando, Florida, Spojené státy, 32803
        • Central Florida Cardiology Group
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30342
        • Saint Joseph's Research Institute
    • Illinois
      • Chicago, Illinois, Spojené státy, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Spojené státy, 60611
        • Northwestern University Medical Center, Bluhm Cardiovascluar Institute
    • Iowa
      • Iowa City, Iowa, Spojené státy, 52242
        • University of Iowa Hospitals & Clinic
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Spojené státy, 02135
        • Caritas Saint Elizabeth's Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55407
        • Abbott Northwestern Hospital
    • New York
      • New York, New York, Spojené státy, 10032
        • New York Presbyterian Hospital - Columbia University Medical Center
      • New York, New York, Spojené státy, 10065
        • New York Presbyterian Hospital - Weill Cornell Medical College of Cornell University
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45267
        • University of Cincinnati Medical Center
      • Cincinnati, Ohio, Spojené státy, 45219
        • The Lindner Clinical Trial Center
      • Cleveland, Ohio, Spojené státy, 44106
        • University Hospitals Case Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh Medical Center
    • Washington
      • Seattle, Washington, Spojené státy, 98122
        • Swedish Heart & Vascular - Swedish Medical Center
    • Wisconsin
      • Madison, Wisconsin, Spojené státy, 53792
        • University of Wisconsin Medical School
      • Milwaukee, Wisconsin, Spojené státy, 53223
        • Comprehensive Cardiovascular Care Group

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

21 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Biologický: CLBS14 (low-dose)
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.
Ostatní jména:
  • G-CSF mobilized, autologous CD34+ cells
Experimentální: 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
Biologický: CLBS14 (high-dose)
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.
Ostatní jména:
  • G-CSF mobilized, autologous CD34+ cells
Komparátor placeba: Placebo injection
10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma
Biologický: placebo injection
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.
Ostatní jména:
  • 0.9% NaCl (saline) in 5% autologous plasma

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Angina Episodes Per Week at 6 and 12 Months
Časové okno: 6 and 12 months
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise
Časové okno: Change from Baseline to 6 months and change from baseline to 12 months after treatment
A modified Bruce Protocol Exercise Treadmill Test was used to evaluate duration of exercise in all subjects.
Change from Baseline to 6 months and change from baseline to 12 months after treatment
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Časové okno: Baseline and 12 months after treatment

The Canadian Cardiovascular Society (CCS) Functional Classification of Angina is as follows:

  • Class I - Angina only during strenuous or prolonged physical activity
  • Class II - Slight limitation, with angina only during vigorous physical activity
  • Class III - Symptoms with everyday living activities, i.e., moderate limitation
  • Class IV - Inability to perform any activity without angina or angina at rest, i.e., severe limitation
Baseline and 12 months after treatment
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Časové okno: 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.
Baseline to 6 months after treatment
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Časové okno: 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.
Baseline to 6 months after treatment
Change in Anti-anginal Medication (ie, Nitroglycerin) Use
Časové okno: Baseline to 6 months
The mean nitroglycerin use per week was analyzed at baseline and 6 months
Baseline to 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Lisata Therapeutics, Inc.

Vyšetřovatelé

  • Ředitel studie: Caladrius Study DIrector, Lisata Therapeutics, Inc.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2006

Primární dokončení (Aktuální)

1. března 2008

Dokončení studie (Aktuální)

1. března 2009

Termíny zápisu do studia

První předloženo

6. března 2006

První předloženo, které splnilo kritéria kontroly kvality

6. března 2006

První zveřejněno (Odhad)

8. března 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. ledna 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. ledna 2021

Naposledy ověřeno

1. ledna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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