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ACT34-CMI -- Adult Autologous CD34+ Cells

8 gennaio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

321

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 21 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Biologico: 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.
Altri nomi:
  • G-CSF mobilized, autologous CD34+ cells
Sperimentale: 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
Biologico: 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.
Altri nomi:
  • G-CSF mobilized, autologous CD34+ cells
Comparatore placebo: Placebo injection
10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma
Biologico: 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.
Altri nomi:
  • 0.9% NaCl (saline) in 5% autologous plasma

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Angina Episodes Per Week at 6 and 12 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline to 6 months
The mean nitroglycerin use per week was analyzed at baseline and 6 months
Baseline to 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Lisata Therapeutics, Inc.

Investigatori

  • Direttore dello studio: Caladrius Study DIrector, Lisata Therapeutics, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2006

Completamento primario (Effettivo)

1 marzo 2008

Completamento dello studio (Effettivo)

1 marzo 2009

Date di iscrizione allo studio

Primo inviato

6 marzo 2006

Primo inviato che soddisfa i criteri di controllo qualità

6 marzo 2006

Primo Inserito (Stima)

8 marzo 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 24779

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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