Ischemic Heart DiseasePhase 1/2NCT01353690
Autologous Cell Therapy for Ischemic Heart Failure
A Phase 1/2 study testing AMDC in people with Ischemic Heart Disease, run by Cook MyoSite at 2 sites in Canada.
Trial summary
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- AMDC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Feb 2011to Jun 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 but less than 80 years
- Prior myocardial infarction
- Depressed left ventricular ejection fraction (LVEF) ≤ 35%
- NYHA functional classification of II to IV
Who cannot join
- Not under stable optimal medical management
- Cardiac surgery or percutaneous coronary intervention within 3 months
- Occurrence of myocardial infarction (MI) within 6 months, in the case of first MI, or 3 months, in the case of any subsequent MI
- Prior cell, gene, or transmyocardial laser revascularization therapy
- Ventricular wall thickness in target region ≤ 5 mm
- Moderate to severe aortic valve stenosis or mechanical valve replacement
Show all 22Show fewer
- Left ventricular aneurysm or thrombus
- Left ventricular dysfunction associated with a reversible cause
- Vascular disease preventing percutaneous vascular access
- History of myopathic disease
- History of neoplasia within 5 years, except for basal cell carcinoma
- Receiving or planning to receive anti-cancer medications
- Serum creatinine > 3.0 mg/dl
- Pregnant, planning to become pregnant, or breastfeeding a child in the next 18 months
- Life expectancy of less than 1 year
- Morbid obesity (defined as BMI > 35)
- History of bleeding diathesis or coagulopathy
- Positive for HIV, Hepatitis B, or Hepatitis C
- Known hypersensitivity or contraindication to study product or treatment procedure
- Enrolled in another research project at the time of enrollment
- Unable to provide informed consent
- Unable or unwilling to commit to the follow-up clinical procedures
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta and Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
About this study
Official title: A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.
- Conditions
- Ischemic Heart Disease
- Being tested
- AMDC
- Keywords
- Cell Therapy, Heart Failure, Heart Disease, Myocardial Infarction, Myocardial Ischemia, Autologous, Muscle-derived Cell
- Medical subject headings
- Myocardial Ischemia, Heart Failure, Heart Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMDCBiological
Cell Treatment
| Study group | Role | What they receive |
|---|---|---|
| AMDC | Experimental | Not described Receives: Biological: AMDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events associated with the use of AMDC
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 posted16 May 2011 (estimated)
- Study start5 Feb 2011
- Primary completion12 Dec 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hung Q. Ly, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353690
- Sponsor's protocol ID
- 10-013
- Status last verified
- Jun 2021
- First submitted
- 12 May 2011
- Last updated
- 1 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT01353690
- Acronym / sponsor ID
- 10-013
- Conditions
- Ischemic Heart Disease
- Keywords
- Cell Therapy, Heart Failure, Heart Disease, Myocardial Infarction, Myocardial Ischemia, Autologous, Muscle-derived Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2011 (actual)
- Primary completion
- 12 Dec 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 May 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 aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMDC | Experimental | Biological: AMDC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 but less than 80 years
- Prior myocardial infarction
- Depressed left ventricular ejection fraction (LVEF) ≤ 35%
- NYHA functional classification of II to IV
Key exclusion criteria (22 listed)
- Not under stable optimal medical management
- Cardiac surgery or percutaneous coronary intervention within 3 months
- Occurrence of myocardial infarction (MI) within 6 months, in the case of first MI, or 3 months, in the case of any subsequent MI
- Prior cell, gene, or transmyocardial laser revascularization therapy
- Ventricular wall thickness in target region ≤ 5 mm
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 |
|---|---|---|
| AMDCCell Treatment | Biological | AMDC |
Primary outcome
Incidence of major adverse events associated with the use of AMDC
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 1 Jul 2021.
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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.
Hung Q. Ly, MD principal investigator
Montreal Heart Institute
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 AMDC in people with Ischemic Heart Disease, run by Cook MyoSite at 2 sites in Canada.
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 4 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: stopped early, as of the sponsor's last update on 1 Jul 2021. 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 Canada. 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?
Incidence of major adverse events associated with the use of AMDC (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 1 Jul 2021.