Congestive Heart FailurePhase 1/2NCT01074099

Feasibility Study of BMAC Enhanced CABG

A Phase 1/2 study testing BMAC and CABG only in people with Congestive Heart Failure, run by Harvest Technologies at 2 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

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Congestive Heart Failure
What is being tested?: BMAC and CABG only
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 2 sitesUnited States
Study dates: Feb 2011to Apr 2013
Phase: Phase 1/2
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

Age> 18 years and ability to understand the planned treatment.
Patients with ischemic congestive heart failure requiring by pass surgery
Congestive heart failure with ejection fraction ≤ 40%.
Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.
Serum creatinine < 3.0 or no dialysis.
NYHA performance status ≥ 3.

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Negative pregnancy test (in women with childbearing potential).
Subject has read and signed the IRB approved Informed Consent form
Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery

Who cannot join

Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
History of Prior Radiation Exposure for oncological treatment.
History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
History of abnormal Bleeding or Clotting.
History of Liver Cirrhosis.
Acute Myocardial Infarction < 4 weeks from treatment date.

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Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free.
Active clinical infection being treated by antibiotics within one week of enrollment
Terminal renal failure with existing dependence on dialysis
Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
Unable to have 250cc bone marrow harvested.
Medical risk that precludes anesthesia or ASA Class 5
History of ventricular arrhythmia if AICD is not present.
History of ventricular aneurysm.
Concurrent surgery such as CABG with valve surgery.
Minimally Invasive bypass surgery
Life expectancy <6 months due to concomitant illnesses
Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day)
Patients undergoing urgent by pass surgical procedure
Patients with HGB A1C > 8.5%

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The Methodist Hospital
Houston, Texas, 77030
University of Utah
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

Read the detailed description

Conditions: Congestive Heart Failure
Being tested: BMAC, CABG only
Medical subject headings: Heart Failure

What participants receive

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

BMACBiological
Injection of BMAC into ischemic myocardium during CABG
CABG onlyProcedure or surgery
Control subjects will undergo CABG surgery without BMAC injection

Study groups in NCT01074099
Study group	Role	What they receive
Control	Active comparator	CABG only Receives: Procedure: CABG only
BMAC enhanced CABG	Experimental	Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery Receives: Biological: BMAC

What is being measured

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

Change in Cardiac Status (Classification)
A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Measured: Through 12 months post treatment
Safety
as measured by frequency and severity of adverse events
Measured: through 1 Year post tx

Timeline

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

Feb 2011Apr 2013

First posted24 Feb 2010 (estimated)
Study startFeb 2011
Primary completionApr 2013
Study completionApr 2013

Why it stopped: Pilot results in change to protocol, new study needed.

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 Congestive Heart FailureStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01074099
Sponsor's protocol ID: Harvest 2009-1
Status last verified: Aug 2014
First submitted: 1 Feb 2010
Last updated: 18 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery
ClinicalTrials.gov ID: NCT01074099
Acronym / sponsor ID: Harvest 2009-1
Conditions: Congestive Heart Failure
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Pilot results in change to protocol, new study needed.
Enrolment: 5 participants (actual)
Lead sponsor: Harvest TechnologiesIndustry (pharma, biotech, devices)
Collaborators: University of Utah
Study start: Feb 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 24 Feb 2010 (estimated)
Results: Posted 18 Jan 2016

Clinical summary

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

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Procedure: CABG onlyCABG only
BMAC enhanced CABG	Experimental	Biological: BMACInjection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery

Who may qualify

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

Key inclusion criteria (9 listed)

Age> 18 years and ability to understand the planned treatment.
Patients with ischemic congestive heart failure requiring by pass surgery
Congestive heart failure with ejection fraction ≤ 40%.
Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.
Serum creatinine < 3.0 or no dialysis.

Key exclusion criteria (20 listed)

Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
History of Prior Radiation Exposure for oncological treatment.
History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
History of abnormal Bleeding or Clotting.
History of Liver Cirrhosis.

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
BMACInjection of BMAC into ischemic myocardium during CABG	Biological	BMAC enhanced CABG
CABG onlyControl subjects will undergo CABG surgery without BMAC injection	Procedure or surgery	Control

Primary outcome

Change in Cardiac Status (Classification)
Time frame: Through 12 months post treatment
A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Safety
Time frame: through 1 Year post tx
as measured by frequency and severity of adverse events

Results and safety

Results posted to the registry on 18 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	2	2
BMAC Enhanced CABG	3	3

Primary outcome: Change in Cardiac Status (Classification)

Time frame: Through 12 months post treatment

Population analysed: Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.

Primary outcome: Safety

Time frame: through 1 Year post tx. Number. Unit: participants

Measure	Control n = 2	BMAC Enhanced CABG n = 3
Value	0	0

Adverse events

Time frame: From time of treatment through 1 year / study termination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 2 (0%)	0 of 2 (0%)	Not reported
BMAC Enhanced CABG	1 of 3 (33.3%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early. Only 5 subjects were enrolled and they were followed for a year for safety data only. One efficacy data was collected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Congestive Heart Failure

RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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.

Amit Patel, MD principal investigator

University of Utah

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMAC and CABG only in people with Congestive Heart Failure, run by Harvest Technologies at 2 sites in United States.

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 9 inclusion and 20 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Jan 2016). 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?

Change in Cardiac Status (Classification) (time frame: Through 12 months post treatment). The study lists 2 primary outcomes in all. 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 NCT01074099.

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 18 Jan 2016.