Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383630
Status:
TERMINATED
Last Update Posted:
2019-04-17
First Post:
2006-09-29
Brief Title:
Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Effect of Intramyocardial Injection of Immunoselected Bone Marrow Cells on Myocardial Function in LVAD Bridge to Transplant Patients
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to logistical barriers to cell processing and poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart failure is a condition in which the heart is unable to pump enough blood to the bodys other organs A heart transplant may be necessary for some individuals with end-stage heart failure Left ventricular assist devices LVADs can assist the heart in pumping blood and are commonly used until a donor heart becomes available Bone marrow cells injected into the heart may improve heart function and may lead to earlier LVAD removal The purpose of this study is to evaluate the safety and effectiveness of injected bone marrow cells in improving heart function in individuals with LVADs who are awaiting heart transplants
Detailed Description:
Congestive heart failure affects 5 million people in the United States and over 60000 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 3000 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 n30 participants will undergo intramyocardial injection of bone marrow mononuclear cells BMCs during LVAD implantation
Group 2 n30 participants will undergo intramyocardial injection of immunoselected CD34 hematopoietic stem cells during LVAD implantation
Group 3 n15 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
This study will enroll individuals undergoing surgery to receive an LVAD Participants will be randomly assigned to one of following three groups
Group 1 n30 participants will undergo intramyocardial injection of bone marrow mononuclear cells BMCs during LVAD implantation
Group 2 n30 participants will undergo intramyocardial injection of immunoselected CD34 hematopoietic stem cells during LVAD implantation
Group 3 n15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL077096-01 | NIH | None | httpsreporternihgovquickSearchP50HL077096-01 |
| P50HL077096 | NIH | None | None |