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Myocardial InfarctionPhase 2NCT00375817

Safety and Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) Using an Injection Catheter = SEISMIC Trial

A Phase 2 study testing Myoblasts injection with MyoCath catheter in people with Myocardial Infarction and Heart Failure, Congestive, run by Bioheart, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the efficacy and safety of MyoCell therapy on myocardial function in congestive heart failure patients, post-myocardial infarction Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Myoblasts injection with MyoCath catheter
How many people
40 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jan 2008
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • defined region of myocardial dysfunction related to previous MI (most recent MI at least 90 days prior to muscle biopsy involving the anterior, lateral, posterior or inferior walls, assessed by the presence of a Q-wave on the ECG \& a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography
  • NYHA class II or III
  • on optimal medical drug therapy for at least 2 months prior to study entry; defined by the most current ACC/AHA guidelines for the Evaluation \& Management of chronic heart failure in the adult
  • >=18 and <=75 years old
  • need or feasibility for re-vascularization has been r/o by coronary or noninvasive stress testing within 30 days of screening, assessed using Dobutamine Stress Echocardiography
  • able to undergo surgical biopsy of the skeletal muscle \& successful culture of the harvested myoblasts
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  • well demarcated transmural myocardial scar (by echocardiography)Must have a minimum myocardial wall thickness of 5mm
  • must have been fitted w/ an ICD in place for the duration of the study at least 6 months prior to muscle biopsy
  • left ventricular EF at screening of >=20%, <=45% (by MUGA)
  • willing \& able to give written informed consent
  • if female of childbearing potential, serum or urine pregnancy test must be negative w/in 2 weeks of study treatment

Who cannot join

  • MI w/in 90 days of the muscle biopsy
  • NYHA class I or IV
  • CABG w/in 6 months (180 days) prior to scheduled MyoCell implantation
  • PCI w/in 3 months (90 days) prior to scheduled MyoCell implantation
  • aortic valve replacement
  • heart failure secondary to valvular disease
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  • left ventricular mural thrombus
  • known sensitivity to gentamicin sulfate and/or amphotericin-B
  • previous experimental angiogenic therapy and/or myocardial laser therapy
  • previous severe adverse reaction to nonionic radiocontrast agents
  • exposure to any investigational drug or procedure w/in 1 month prior to study entry or enrolled in any concurrent study that may confound the results of this study
  • serum creatinine >2.5 mg/dL or end stage renal disease
  • active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM>IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient's infectious status
  • females who are pregnant or nursing or of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • any illness which might affect patient's survival over the study follow up period or 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
  • patients on chronic immunosuppressive transplant therapy
  • ICDs implanted less than 6 months prior to cellular implantation procedure. ICDs reprogrammed during the course of treatment and stable for less than 3 months. Patients fitted w/a Bi-V pacer are excluded.
  • patients who, in the opinion of the investigator, are not suitable to participate, following review of the catheter information in appendix IV

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Richard Spencer

    Sunrise, Florida, 33325

Other trials in United States

About this study

Official title: A Phase II, Open-Label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCell Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)

To assess the efficacy and safety of MyoCell therapy on myocardial function in congestive heart failure patients, post-myocardial infarction

Being tested
Myoblasts injection with MyoCath catheter
Medical subject headings
Myocardial Infarction, Heart Failure

What participants receive

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

  • Myoblasts injection with MyoCath catheterProcedure or surgery

What is being measured

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

  1. Overall Objective

  2. To assess the effect and safety of MyoCell™ therapy on myocardial function in congestive heart failure patients, post-myocardial infarction(s). Primary Safety Objective

  3. The primary safety objective defined for this study is as follows:

  4. The MyoCell™ implant will be considered safe if the number of serious adverse events at 3 months and 6 months is less than that seen in the control group (receiving standard medical therapy), and falling within levels set in the statistical analysis pla

  5. Primary MyoCellTM Efficacy Objective

  6. The primary efficacy objective of SEISMIC is to demonstrate the response to MyoCell™ implantation on the change in LVEF at 3 and 6 months by MUGA compared to baseline. Comparisons on LVEF will also be made between the two randomized groups (i.e. MyoCell

Timeline

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

  1. First posted13 Sep 2006 (estimated)
  2. Study startNov 2005
  3. Study completionJan 2008 (estimated)

Resources

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
Factorial
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00375817
Sponsor's protocol ID
BMI-EU-02-008
Status last verified
Oct 2007
First submitted
11 Sep 2006
Last updated
12 Oct 2007
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Myoblasts injection with MyoCath catheter in people with Myocardial Infarction and Heart Failure, Congestive, run by Bioheart, Inc. at 1 site 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 11 inclusion and 18 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 12 Oct 2007. 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 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?

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?

Overall Objective. The study lists 6 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 NCT00375817.

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 12 Oct 2007.

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