Congestive Heart FailurePhase 1/2NCT01061580
BMAC Enhanced Coronary Artery Bypass Grafting (CABG)
A Phase 1/2 study testing Harvest SmartPReP2 BMAC System in people with Congestive Heart Failure, run by Harvest Technologies at 1 site in India.
Trial summary
Injection of concentrated bone marrow cells into the myocardium during CABG procedure. 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?
- Harvest SmartPReP2 BMAC System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to Dec 2013
- Phase
- Phase 1/2
- 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
- Subjects must meet all of the following inclusion criteria to be enrolled in the trial:
- 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.
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- NYHA performance status > 3.
- 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
- Subjects will be excluded if they meet any of the exclusion criteria:
- 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.
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- Acute Myocardial Infarction < 4 weeks from treatment date.
- Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult 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
1 site in 1 country.
About this study
Official title: Dose Response Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting (CABG) Surgery
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
Read the detailed description
Injection of autologous concentrated bone marrow cells into the myocardium during CABG procedure.
- Conditions
- Congestive Heart Failure
- Being tested
- Harvest SmartPReP2 BMAC System
- Keywords
- Bone Marrow Concentrate, CABG, Cardiac, Stem Cell
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvest SmartPReP2 BMAC SystemDevice
Injection of 10, 15, or 20 cc of BMAC
| Study group | Role | What they receive |
|---|---|---|
| CABG plus BMAC Injection | Experimental | Injection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure Receives: Device: Harvest SmartPReP2 BMAC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular function
Measured: 12 months
Secondary outcomes (5)
QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire)
Measured: 12 months
NYHA or CCS classification evaluation
Measured: 12 months
Changes in left ventricular ejection fraction
Measured: 12 months
Changes in left ventricular end-diastolic volume
Measured: 12 months
Safety
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 posted3 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionDec 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvest Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naresh Trehan, MD, Principal investigator, Medanta-The Medicity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061580
- Sponsor's protocol ID
- 2009-1
- Status last verified
- Jun 2014
- First submitted
- 16 Dec 2009
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response 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
- NCT01061580
- Acronym / sponsor ID
- 2009-1
- Conditions
- Congestive Heart Failure
- Keywords
- Bone Marrow Concentrate, CABG, Cardiac, Stem Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Harvest TechnologiesIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Feb 2010 (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.
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
Detailed description
Injection of autologous concentrated bone marrow cells into the myocardium during CABG procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG plus BMAC Injection | Experimental | Device: Harvest SmartPReP2 BMAC SystemInjection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 (21 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 |
|---|---|---|
| Harvest SmartPReP2 BMAC SystemInjection of 10, 15, or 20 cc of BMAC | Device | CABG plus BMAC Injection |
Primary outcome
Changes in left ventricular function
Time frame: 12 months
5 secondary outcomes
QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire)
Time frame: 12 months
NYHA or CCS classification evaluation
Time frame: 12 months
Changes in left ventricular ejection fraction
Time frame: 12 months
Changes in left ventricular end-diastolic volume
Time frame: 12 months
Safety
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Naresh Trehan, MD principal investigator
Medanta-The Medicity
1 site 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 Harvest SmartPReP2 BMAC System in people with Congestive Heart Failure, run by Harvest Technologies at 1 site in India.
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 10 inclusion and 21 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study was stopped early. Results are not available in the source record.
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?
Changes in left ventricular function (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 26 Jun 2014.