Congestive Heart FailurePhase 1NCT01299324
Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure
A Phase 1 study testing BMAC infusion in people with Congestive Heart Failure, run by Harvest Technologies at 3 sites in 3 countries.
Trial summary
The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF). 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 infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2011to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Congestive Heart Failure
- Left ventricular ejection fraction ≤40% by echocardiogram, per ECHO completed 30 days prior to treatment
- Symptomatic heart failure NYHA class III or IV
- Able to comply with all study-related visits
- Able to tolerate study procedures, including bone marrow aspiration, SPECT,
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- Able to give informed Consent
- Negative for HcG with a serum pregnancy test
- Patients with controlled diabetes mellitus (HbA1c < 9.0%)
- Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000,
- Life expectancy of 6 months or more in the opinion of the investigator
- Patients requiring high dose corticosteroid therapy (more than 7.5 mg/day) with 1 month before the aspiration or 6 months after the infusion.
- Serum bilirubin, ALT, AST ≤2.5 time the upper level of normal.
- Controlled blood pressure (systolic blood pressure ≤140 and a diastolic blood pressure of ≤90 mmHG) and established anti-hypertensive therapy as necessary prior to entry into the study
- Patient has received stable, standard medical therapy for at least one month with no new medications to treat the disease introduced in the last 3 months.
- Pre-existing condition (e.g. thromboembolic risk, diabetes, hypercholesterolemia are adequately controlled in the opinion of the investigator)
- Fertile patients (male and female) must agree to use an appropriate form of contraception while participating in the study.
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.
- End stage renal disease (Creatinine ≤ 3.0 mg / dl) and/or dialysis
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- Acute Myocardial Infarction < 1 week from treatment date.
- Active clinical infection being treated by antibiotics within one week of enrollment
- Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- Unable to have 250cc bone marrow harvested.
- History of life-threatening arrhythmias, except if an automated implantable cardioverter defibrillator (AICD) is implanted
- Life expectancy <6 months due to concomitant illnesses
- Known cancer and undergoing treatment; chemotherapy and/or radiotherapy
- Patients receiving treatment with hematopoietic growth factors (e.g., EPO, G-CSF)
- Patients who can not stop anticoagulation therapy (warfarin) 72hrs prior to bone marrow aspiration and infusion
- Patients who can not stop anti-platelet therapy (clopidogrel) 7 days prior to bone marrow aspiration and infusion
- History of alcohol consumption exceeding the equivalent of 2 drinks/daily (1 drink = 5oz wine, 12oz of beer, or 1.5oz hard liquor) or illicit drug use within 6 months of screening.
- Patient who will require continuous high dose corticosteroid therapy (more than 7.5mg/day) within 1 month before aspiration or 6 months after injection procedure.
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor, the patient is unsuitable for cellular therapy
- Known allergy or sensitivity to contrast agents used in imaging procedures.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Feasibility Study of Retrograde Delivery of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Patients Diagnosed With Congestive Heart Failure (CHF)
The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF).
Read the detailed description
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.
To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina and heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.
To assess the effect of the infusion of bone marrow nucleated cells on heart function as measured by ejection fraction (EF) and left ventricular end-diastolic diameter (LVEDD) by ECHO.
To assess the effect of the infusion of bone marrow nucleated cells on the area of ischemia as measured by myocardial SPECT studies and ECHO.
- Conditions
- Congestive Heart Failure
- Being tested
- BMAC infusion
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC infusionDevice
Also called Coronary infusion of BMAC
Infusion of 60 mL of Bone Marrow Aspirate Concentrate
| Study group | Role | What they receive |
|---|---|---|
| BMAC Infusion | Experimental | Infusion of autologous bone marrow aspirate concentrated nucleated sells into the coronary sinus Receives: Device: BMAC infusion |
| Control | No intervention | Standard of care only. No infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.
Measured: 12 Months
Secondary outcomes (2)
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina
To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.
Measured: 12 Months
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure
To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvest Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amit Patel, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299324
- Sponsor's protocol ID
- CHF2011-1
- Status last verified
- Aug 2014
- First submitted
- 10 Jan 2011
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Retrograde Delivery of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Patients Diagnosed With Congestive Heart Failure (CHF)
- ClinicalTrials.gov ID
- NCT01299324
- Acronym / sponsor ID
- CHF2011-1
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Harvest TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF).
Detailed description
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.
To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina and heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.
To assess the effect of the infusion of bone marrow nucleated cells on heart function as measured by ejection fraction (EF) and left ventricular end-diastolic diameter (LVEDD) by ECHO.
To assess the effect of the infusion of bone marrow nucleated cells on the area of ischemia as measured by myocardial SPECT studies and ECHO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC Infusion | Experimental | Device: BMAC infusionInfusion of autologous bone marrow aspirate concentrated nucleated sells into the coronary sinus |
| Control | No intervention | –Standard of care only. No infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years and ability to understand the planned treatment.
- Patients with Congestive Heart Failure
- Left ventricular ejection fraction ≤40% by echocardiogram, per ECHO completed 30 days prior to treatment
- Symptomatic heart failure NYHA class III or IV
- Able to comply with all study-related visits
Key exclusion criteria (22 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 |
|---|---|---|
| BMAC infusionAlso: Coronary infusion of BMACInfusion of 60 mL of Bone Marrow Aspirate Concentrate | Device | BMAC Infusion |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 12 Months
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.
2 secondary outcomes
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina
Time frame: 12 Months
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMAC infusion in people with Congestive Heart Failure, run by Harvest Technologies at 3 sites in 3 countries.
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 17 inclusion and 22 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: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, India, Peru. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.