Heart Failure, CongestivePhase 2NCT00383630

Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

A Phase 2 study testing Intramyocardial injection of bone marrow mononuclear cells, Intramyocardial injection of CD34+ selected bone marrow mononuclear cells and LVAD alone in people with Heart Failure, Congestive, run by Columbia University at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Congestive
What is being tested?: Intramyocardial injection of bone marrow mononuclear cells, Intramyocardial injection of CD34+ selected bone marrow mononuclear cells and LVAD alone
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 7 sitesUnited States
Study dates: Sep 2007to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Jewish Hospital
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53792-3236
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Columbia University
New York, New York, 10032
Montefiore Medical Center
New York, New York, 10467
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4227

Other trials in United States

About this study

Official title: The Effect of Intramyocardial Injection of Immunoselected Bone Marrow Cells on Myocardial Function in LVAD Bridge to Transplant Patients

Heart failure is a condition in which the heart is unable to pump enough blood to the body's 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.

Read the detailed description

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.

Conditions: Heart Failure, Congestive
Being tested: Intramyocardial injection of bone marrow mononuclear cells, Intramyocardial injection of CD34+ selected bone marrow mononuclear cells, LVAD alone
Keywords: End Stage Heart Failure, LVAD, Bone Marrow Transplantation, Stem Cell Transplantation
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intramyocardial injection of bone marrow mononuclear cellsBiological
Also called BMCs + LVAD
6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
Intramyocardial injection of CD34+ selected bone marrow mononuclear cellsBiological
Also called CD34+ selected BMCs + LVAD
6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
LVAD aloneDevice
LVAD implantation without any intramyocardial injection of bone marrow cells.

Study groups in NCT00383630
Study group	Role	What they receive
Group 1	Experimental	Intramyocardial injection of bone marrow mononuclear cells + LVAD Receives: Biological: Intramyocardial injection of bone marrow mononuclear cells
Group 2	Experimental	Intramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD Receives: Biological: Intramyocardial injection of CD34+ selected bone marrow mononuclear cells
Group 3	Other	LVAD alone Receives: Device: LVAD alone

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Time (Minutes) a Patient is Able to Tolerate Wean
This defines the functional status. Due to poor enrollment, data was not analyzed.
Measured: Measured 90 days post-intervention

Secondary outcomes (2)

Prevalence of Normal Echocardiographic Assessments
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: Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant
Number of Patients Who Completed a Six Minute Walk
6 Minute walk as tolerated at 15 minutes following initiation of hand pumping.
Due to poor enrollment, results was not analyzed.
Measured: Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Dec 2008

First posted3 Oct 2006 (estimated)
Study startSep 2007
Primary completionDec 2008
Study completionDec 2008

Why it stopped: Terminated due to logistical barriers to cell processing and poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00383630
Sponsor's protocol ID: AAAC2128
Other IDs: P50HL077096, P50HL077096-01
Status last verified: Mar 2019
First submitted: 29 Sep 2006
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
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Not yet recruiting
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All Heart Failure, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intramyocardial Injection of Immunoselected Bone Marrow Cells on Myocardial Function in LVAD Bridge to Transplant Patients
ClinicalTrials.gov ID: NCT00383630
Acronym / sponsor ID: AAAC2128
Conditions: Heart Failure, Congestive
Keywords: End Stage Heart Failure, LVAD, Bone Marrow Transplantation, Stem Cell Transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to logistical barriers to cell processing and poor enrollment
Enrolment: 1 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Sep 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 3 Oct 2006 (estimated)
Results: Posted 17 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: Intramyocardial injection of bone marrow mononuclear cellsIntramyocardial injection of bone marrow mononuclear cells + LVAD
Group 2	Experimental	Biological: Intramyocardial injection of CD34+ selected bone marrow mononuclear cellsIntramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD
Group 3	Other	Device: LVAD aloneLVAD alone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intramyocardial injection of bone marrow mononuclear cellsAlso: BMCs + LVAD6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.	Biological	Group 1
Intramyocardial injection of CD34+ selected bone marrow mononuclear cellsAlso: CD34+ selected BMCs + LVAD6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.	Biological	Group 2
LVAD aloneLVAD implantation without any intramyocardial injection of bone marrow cells.	Device	Group 3

Primary outcome

Duration of Time (Minutes) a Patient is Able to Tolerate Wean
Time frame: Measured 90 days post-intervention
This defines the functional status. Due to poor enrollment, data was not analyzed.

2 secondary outcomes

Prevalence of Normal Echocardiographic Assessments
Time frame: Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant
Number of Patients Who Completed a Six Minute Walk
Time frame: Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant

Results and safety

Results posted to the registry on 17 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Subjects	1	1

Primary outcome: Duration of Time (Minutes) a Patient is Able to Tolerate Wean

Time frame: Measured 90 days post-intervention

Population analysed: The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Subjects	1 of 1 (100%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure, Congestive

Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
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RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Recruiting
Peripheral Venous Pressure (PVP) Trial
Congestive Heart Failure
Not yet recruiting
Digital Outreach for Heart Failure Adherence
CHF - Congestive Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoshifumi Naka, MD principal investigator

Columbia University

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Time (Minutes) a Patient is Able to Tolerate Wean (time frame: Measured 90 days post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00383630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019; AzTrials last refreshed its copy on 3 Nov 2026.