Congestive Heart FailurePhase 1NCT00050765
Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
A Phase 1 study testing MyoCell™ Autologous Myoblasts in people with Congestive Heart Failure and Coronary Artery Disease, run by Bioheart, Inc. at 5 sites in United States.
Trial summary
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function. Based on existing non-clinical studies and clinical reports, implantation of autologous skeletal myoblasts appears to lead to the replacement… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- MyoCell™ Autologous Myoblasts
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2006to Aug 2006
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Defined region of myocardial dysfunction related to previous myocardial infarction involving the anterior, lateral, posterior or inferior walls, > 12 weeks old at the scheduled time of MyoCell™ implantation procedure
- Patients must have an implantable cardioverter defibrillator (ICD) in place or, patients must receive ICD placement during the CABG procedure or 3 to 4 days after the CABG procedure
- Planned CABG procedure for revascularization
- Heart failure patient in New York Heart Association Symptom Class 2 or 3 who is on optimal medical therapy
- Age > 18 and < 80 years
- Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts
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- Target region wall thickness > 6 mm by echocardiography
- Left ventricular ejection fraction > 20% and < 40% by radionuclide ventriculography or left ventricular angiography at screening
- If a female of childbearing potential, urine pregnancy test must be negative
- Able to give written informed consent
Who cannot join
- Patient medically unable to undergo CABG surgery
- Any patient who has had a documented myocardial infarction (ECG changes or elevated cardiac enzymes consistent with MI) within 30 days of the scheduled surgical revascularization and cellular implantation procedure.
- Known sensitivity to gentamicin sulfate and/or amphotericin-B
- Exposure to any investigational drug or procedure within 4 weeks prior to study entry
- The use or expected use of antineoplastic drugs
- History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.) as determined by a board certified pathologist examining sample of patients muscle biopsy
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- Previous angiogenic therapy and/or myocardial laser therapy
- History of cancer within 5 years, except for basal cell carcinoma of the skin
- PSA suggestive of carcinoma of the prostate (i.e., > 4)
- Patient with CEA >2.5 ng/mL or end stage renal disease
- Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis. If the panel includes antibodies to the HBc and HBV-sAg, then an expert will be consulted.
- Females who are pregnant or nursing. Females of childbearing potential must be using to the investigator's satisfaction, a medically accepted method of birth control (e.g., but not limited to, oral or implanted contraceptive therapy or intrauterine devices) and agree to continue for the duration of the study.
- Any illness which might affect patient's survival over the study follow-up period
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
- Patient with an any previous cardiac surgery
- Patient with valvular disease greater than mild in degree which is considered the primary cause of their heart failure
- Patient in New York Heart Association Symptom Class 1 or 4
- Patient with serum creatinine > 2.5
- No informed consent or unable to provide informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
ACRI
Atlanta, Georgia, 30342
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
Gary Schaer, MD FACC, 312-942-4655, gschaer@rush.edu
Carrie Schlaffer, BS, CCRC, (312) 942-8901, Carrie_Schlaffer@rush.edu
Duke University
Durham, North Carolina, 27705
Bioheart, Inc
Fort Lauderdale, Florida, 33326
Richard Spencer, JD, MBA, (954) 835-1500, RSpencer@bioheartinc.com
Doug Owends, RN, BSN, CCRA, (954) 835-1500, dowens@bioheartinc.com
Mt. Sinai Medical Center
New York, New York, 10029
About this study
Official title: A Phase I Multi-Center Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation in Patients With a Previous MI and Placement of an ICD Requiring De Novo Coronary Artery Bypass Graft Therapy
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function. Based on existing non-clinical studies and clinical reports, implantation of autologous skeletal myoblasts appears to lead to the replacement of non-functioning myocardial scar with functioning muscle and appears to improve myocardial performance relative to case without myoblast implantation. In a few investigational patients, myoblast implantation can be, and has been, done in conjunction with CABG and appears to have the potential to provide for additive treatment during surgery. The present study is being conducted to evaluate more fully the safety of MyoCell™ implantation via epicardial injection during CABG surgery and its effect on regional myocardial function.
Read the detailed description
MyoCell™ mediated cellular cardiomyoplasty is a novel therapeutic approach to the management of progressive heart failure in patients who have damaged myocardial tissue resulting from a myocardial infarct. MyoCell™ consists of patient autologous skeletal myoblasts which are expanded ex vivo and supplied as a cell suspension in a buffered salts solution for injection into the area of damaged, akinetic myocardium with the goal of having the myoblasts populate the implant area and generate elastic, contractile skeletal muscle-like tissue within the damaged myocardium. Because the physiological goal is to replace inelastic, fibrous myocardial scar tissue with skeletal muscle-like tissue, originating from the cellular implants, this therapeutic approach is termed "cellular cardiomyoplasty" or "CCM".
The purpose of this trial is to assess the safety of MyoCell™(expanded autologous skeletal myoblasts) using a dose escalation methodology following epicardial injection into myocardial scar tissue in patients who have experienced anterior, lateral, posterior or inferior wall myocardial infarction, require coronary artery bypass graft (CABG) surgery and who have an implantable cardioverter defibrillator (ICD) in place (ICD can be implanted during the CABG procedure or 3 to 4 days post CABG procedure). Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell™ treatment.
If a patient meets the baseline enrollment criteria, a 5-10 gram skeletal muscle biopsy will be obtained for myoblast isolation and expansion in vitro at Bioheart's designated facility for MyoCell™ production. Biopsy will occur 3 - 4 weeks prior to the anticipated implantation of the MyoCell™ product. At the time of the patient's CABG surgery MyoCell™ will be injected into the akinetic myocardial scar in the region of a previous infarct utilizing a sterile hypodermic syringe fitted with a 25 gauge needle.
This will be a dose escalation study with 3 cohort groups consisting of 5 patients each. A report of the 1 month safety data from each cohort will be presented to the data safety monitoring board for permission to go to the next higher dosage. In the first cohort of this dose escalation study; 2 injections will be performed, for the second cohort; 6 injections and for the third cohort; 18 injections depending on the size of the infarct scar, so as to inject the entire myocardial infarct scar akinetic area.
- Being tested
- MyoCell™ Autologous Myoblasts
- Keywords
- Myocardial Infarction, Heart disease, Coronary bypass graft (CABG) surgery, Implantable Cardioverter Defibrillator (ICD), CABG, ICD, Heart failure
- Medical subject headings
- Heart Failure, Coronary Artery Disease, Myocardial Infarction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoCell™ Autologous MyoblastsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2002 (estimated)
- Study startAug 2006
- Study completionAug 2006
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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Bioheart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050765
- Sponsor's protocol ID
- Protocol BMI-US-01-001
- Other IDs
- Version F
- Status last verified
- Mar 2006
- First submitted
- 18 Dec 2002
- Last updated
- 8 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multi-Center Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation in Patients With a Previous MI and Placement of an ICD Requiring De Novo Coronary Artery Bypass Graft Therapy
- ClinicalTrials.gov ID
- NCT00050765
- Acronym / sponsor ID
- Protocol BMI-US-01-001
- Keywords
- Myocardial Infarction, Heart disease, Coronary bypass graft (CABG) surgery, Implantable Cardioverter Defibrillator (ICD), CABG, ICD, Heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- Bioheart, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Aug 2006
- First posted
- 19 Dec 2002 (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.
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function. Based on existing non-clinical studies and clinical reports, implantation of autologous skeletal myoblasts appears to lead to the replacement of non-functioning myocardial scar with functioning muscle and appears to improve myocardial performance relative to case without myoblast implantation. In a few investigational patients, myoblast implantation can be, and has been, done in conjunction with CABG and appears to have the potential to provide for additive treatment during surgery. The present study is being conducted to evaluate more fully the safety of MyoCell™ implantation via epicardial injection during CABG surgery and its effect on regional myocardial function.
Detailed description
MyoCell™ mediated cellular cardiomyoplasty is a novel therapeutic approach to the management of progressive heart failure in patients who have damaged myocardial tissue resulting from a myocardial infarct. MyoCell™ consists of patient autologous skeletal myoblasts which are expanded ex vivo and supplied as a cell suspension in a buffered salts solution for injection into the area of damaged, akinetic myocardium with the goal of having the myoblasts populate the implant area and generate elastic, contractile skeletal muscle-like tissue within the damaged myocardium. Because the physiological goal is to replace inelastic, fibrous myocardial scar tissue with skeletal muscle-like tissue, originating from the cellular implants, this therapeutic approach is termed "cellular cardiomyoplasty" or "CCM".
The purpose of this trial is to assess the safety of MyoCell™(expanded autologous skeletal myoblasts) using a dose escalation methodology following epicardial injection into myocardial scar tissue in patients who have experienced anterior, lateral, posterior or inferior wall myocardial infarction, require coronary artery bypass graft (CABG) surgery and who have an implantable cardioverter defibrillator (ICD) in place (ICD can be implanted during the CABG procedure or 3 to 4 days post CABG procedure). Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell™ treatment.
If a patient meets the baseline enrollment criteria, a 5-10 gram skeletal muscle biopsy will be obtained for myoblast isolation and expansion in vitro at Bioheart's designated facility for MyoCell™ production. Biopsy will occur 3 - 4 weeks prior to the anticipated implantation of the MyoCell™ product. At the time of the patient's CABG surgery MyoCell™ will be injected into the akinetic myocardial scar in the region of a previous infarct utilizing a sterile hypodermic syringe fitted with a 25 gauge needle.
This will be a dose escalation study with 3 cohort groups consisting of 5 patients each. A report of the 1 month safety data from each cohort will be presented to the data safety monitoring board for permission to go to the next higher dosage. In the first cohort of this dose escalation study; 2 injections will be performed, for the second cohort; 6 injections and for the third cohort; 18 injections depending on the size of the infarct scar, so as to inject the entire myocardial infarct scar akinetic area.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Defined region of myocardial dysfunction related to previous myocardial infarction involving the anterior, lateral, posterior or inferior walls, > 12 weeks old at the scheduled time of MyoCell™ implantation procedure
- Patients must have an implantable cardioverter defibrillator (ICD) in place or, patients must receive ICD placement during the CABG procedure or 3 to 4 days after the CABG procedure
- Planned CABG procedure for revascularization
- Heart failure patient in New York Heart Association Symptom Class 2 or 3 who is on optimal medical therapy
- Age > 18 and < 80 years
Key exclusion criteria (19 listed)
- Patient medically unable to undergo CABG surgery
- Any patient who has had a documented myocardial infarction (ECG changes or elevated cardiac enzymes consistent with MI) within 30 days of the scheduled surgical revascularization and cellular implantation procedure.
- Known sensitivity to gentamicin sulfate and/or amphotericin-B
- Exposure to any investigational drug or procedure within 4 weeks prior to study entry
- The use or expected use of antineoplastic drugs
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 |
|---|---|---|
| MyoCell™ Autologous Myoblasts | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2006.
- Bioheart Inc. websiteLink provided by the sponsor.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MyoCell™ Autologous Myoblasts in people with Congestive Heart Failure and Coronary Artery Disease, run by Bioheart, Inc. at 5 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 10 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 8 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doug Owens, RN, BSN ((954) 835-1500 ext. 100, dowens@bioheartinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 8 Mar 2006.