Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
The Effect of Intramyocardial Injection of Immunoselected Bone Marrow Cells on Myocardial Function in LVAD Bridge to Transplant Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Congestive heart failure affects 5 million people in the United States, and over 60,000 are diagnosed with end-stage heart failure. Treatment options for these individuals are extremely limited. Because of a limited supply of donor organs, fewer than 3,000 people receive heart transplants each year. LVADs are battery-operated devices that can act as a temporary solution until a donor heart becomes available. Upon being surgically implanted into a weakened heart, the LVAD mechanically pumps blood from the heart to the rest of the body. There are, however, serious risks associated with LVADs, including infection, blood clots, and stroke. Early removal of the LVAD may be possible by injecting stem cells to regenerate new heart cells and improve heart function. The purpose of this study is to compare the safety and effectiveness of two types of bone marrow cells -- bone marrow mononuclear cells (BMCs) and immunoselected CD34+ hematopoietic stem cells -- in improving heart function in individuals with end-stage heart failure.
This study will enroll individuals undergoing surgery to receive an LVAD. Participants will be randomly assigned to one of following three groups:
Group 1 (n=30): participants will undergo intramyocardial injection of bone marrow mononuclear cells (BMCs) during LVAD implantation
Group 2 (n=30): participants will undergo intramyocardial injection of immunoselected CD34+ hematopoietic stem cells during LVAD implantation
Group 3 (n=15): participants will undergo LVAD implantation
Prior to LVAD implantation, participants in Groups 1 and 2 will have a sample of bone marrow removed. Following LVAD implantation, study visits will occur at Days 45 and 90, and then every 60 days thereafter until participants receive a heart transplant. At each visit, participants will undergo a LVAD wean procedure, during which the mechanical pump of the LVAD will be gradually turned off, and the LVAD will be operated with a hand pump. The length of time that a participant tolerates the wean procedure will be evaluated. Heart size and function, blood flow, and nerve function will also be assessed. Some participants will undergo a 6-minute walk test. At the time of heart transplant surgery, the LVAD will be removed, and heart cell regeneration and heart function will be evaluated.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Christ Medical Center
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Jewish Hospital
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University
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New York, New York, Estados Unidos, 10467
- Montefiore Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4227
- University of Pennsylvania
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792-3236
- University of Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53215
- St. Luke's Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents
- Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test
- Admitted to the clinical center at the time of study entry
- Listed with United Network for Organ Sharing (UNOS) for cardiac transplantation
- Clinical indication and accepted candidate for implantation of an FDA approved LVAD as a bridge to transplantation
- Hemoglobin between 9.0 gm/dl and 16.1 gm/dl within 24 hours prior to study entry
- Platelet count between 100,000/ul and 450,000/ul within 24 hours prior to study entry
- White blood cell count between 2,500/ul and upper limit of normal within 24 hours prior to study entry
Exclusion Criteria
- Cardiothoracic surgery within 30 days prior to study entry
- Myocardial infarction within 6 months prior to study entry
- Prior cardiac transplantation, left ventricular (LV) reduction surgery, or cardiomyoplasty
- Acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)
- Anticipated requirement for biventricular mechanical support
- Stroke within 30 days prior to study entry
- Received investigational intervention within 30 days of study entry
- Pregnant or breastfeeding at time of study entry
- HIV positive within 30 days prior to study entry
- Active systemic infection within 48 hours prior to study entry
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1
Intramyocardial injection of bone marrow mononuclear cells + LVAD
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6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
Otros nombres:
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Experimental: Group 2
Intramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD
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6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
Otros nombres:
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Otro: Group 3
LVAD alone
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LVAD implantation without any intramyocardial injection of bone marrow cells.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of Time (Minutes) a Patient is Able to Tolerate Wean
Periodo de tiempo: Measured 90 days post-intervention
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This defines the functional status.
Due to poor enrollment, data was not analyzed.
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Measured 90 days post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of Normal Echocardiographic Assessments
Periodo de tiempo: Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant
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Echocardiographic assessments of myocardial size and function by transthoracic echocardiography with the LVAD at full support, and as tolerated at 1, 5, 10 and 15 minutes following initiation of hand pumping. Due to poor enrollment, data was not analyzed. |
Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant
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Number of Patients Who Completed a Six Minute Walk
Periodo de tiempo: Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant
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6 Minute walk as tolerated at 15 minutes following initiation of hand pumping. Due to poor enrollment, results was not analyzed. |
Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yoshifumi Naka, MD, Columbia University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAC2128
- P50HL077096 (Subvención/contrato del NIH de EE. UU.)
- P50HL077096-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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