Chronic Ischemic Symptomatic Heart FailurePhase 2NCT00933621
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
A Phase 2 study testing Autologous bone marrow intracoronary infusion in people with Chronic Ischemic Symptomatic Heart Failure, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Chronic Ischemic Symptomatic Heart Failure
- What is being tested?
- Autologous bone marrow intracoronary infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2003to Dec 2003
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography
Who cannot join
- Idiopathic or non-ischemic cardiomyopathy
- Other etiology for heart failure, history of past or current disease involving the bone marrow
- Patients on dialysis
- Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.
Read the detailed description
Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.
- Being tested
- Autologous bone marrow intracoronary infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow intracoronary infusionProcedure or surgery
Also called Intracoronary mononuclear bone marrow cell infusion
Percutaneous intracoronary mononuclear bone marrow cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Autologous Bone Marrow infusion | Experimental | Percutaneous intracoronary autologous bone marrow infusion Receives: Procedure: Autologous bone marrow intracoronary infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success
Measured: 9 months
Secondary outcomes (1)
Functional class improvement
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startApr 2003
- Primary completionMay 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ischemic Symptomatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Alex Blatt, MD, Principal investigator, Assaf Harofeh MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933621
- Sponsor's protocol ID
- 19-03
- Status last verified
- Jul 2009
- First submitted
- 30 Jun 2009
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdel-Latif A, Bolli R, Tleyjeh IM, et al. Adult bone marrow-derived cells for cardiac repair. Arch Intern Med. 2007;167:989-997. 12. Murry CE, Reinecke H and Pabon LM. Regeneration Gaps: Observation on stem cells and cardiac repair. J Am Coll Cardiol. 2006;47:1777-1785.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
- ClinicalTrials.gov ID
- NCT00933621
- Acronym / sponsor ID
- 19-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Apr 2003
- Primary completion
- May 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 7 Jul 2009 (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 study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.
Detailed description
Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Bone Marrow infusion | Experimental | Procedure: Autologous bone marrow intracoronary infusionPercutaneous intracoronary autologous bone marrow infusion |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography
Key exclusion criteria (4 listed)
- Idiopathic or non-ischemic cardiomyopathy
- Other etiology for heart failure, history of past or current disease involving the bone marrow
- Patients on dialysis
- Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease
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 |
|---|---|---|
| Autologous bone marrow intracoronary infusionAlso: Intracoronary mononuclear bone marrow cell infusionPercutaneous intracoronary mononuclear bone marrow cell infusion | Procedure or surgery | Autologous Bone Marrow infusion |
Primary outcome
Procedure success
Time frame: 9 months
1 secondary outcome
Functional class improvement
Time frame: 9 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 7 Jul 2009.
- BackgroundAbdel-Latif A, Bolli R, Tleyjeh IM, et al. Adult bone marrow-derived cells for cardiac repair. Arch Intern Med. 2007;167:989-997. 12. Murry CE, Reinecke H and Pabon LM. Regeneration Gaps: Observation on stem cells and cardiac repair. J Am Coll Cardiol. 2006;47:1777-1785.
Related trials for Chronic Ischemic Symptomatic Heart Failure
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.
Alex Blatt, MD principal investigator
Assaf Harofeh MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous bone marrow intracoronary infusion in people with Chronic Ischemic Symptomatic Heart Failure, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 4 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 7 Jul 2009. 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 Israel. 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?
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?
Procedure success (time frame: 9 months). 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 NCT00933621, which also lists 1 linked publication.
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 7 Jul 2009.