Congestive Heart FailurePhase 2NCT00480961
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
A Phase 2 study testing intramiocardiac autograft of autologous stem cells in people with Congestive Heart Failure, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 1 site in Italy.
Trial summary
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. 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?
- intramiocardiac autograft of autologous stem cells
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- May 2007to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 y/o
- CHF with EF > 35%
- Bilirubinemia, serum transaminase> 2.5 times normal max level
- Creatininemia > 2.5 times max level
- NYHA Class > 3
- Negative pregnancy test (for women in fertile age)
Who cannot join
- Impossibility to harvest the bone marrow
- Pregnancy or breast-feeding
- History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
- Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ismett
Palermo, pa, 90127
CESARE SCARDULLA, md
About this study
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.
Read the detailed description
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.
- Conditions
- Congestive Heart Failure
- Being tested
- intramiocardiac autograft of autologous stem cells
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramiocardiac autograft of autologous stem cellsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
Measured: 1 YEAR
Secondary outcomes (1)
Secondary target: determine clinical effects of grafted cells on remodeling pathology.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startMay 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Sponsor type
- University, hospital or other
- Investigators
- CESARE SCARDULLA, md, Principal investigator, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480961
- Sponsor's protocol ID
- IRRB/00/2006
- Status last verified
- May 2007
- First submitted
- 31 May 2007
- Last updated
- 1 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
- ClinicalTrials.gov ID
- NCT00480961
- Acronym / sponsor ID
- IRRB/00/2006
- Conditions
- Congestive Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUniversity, hospital or other
- Study start
- May 2007
- First posted
- 1 Jun 2007 (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.
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.
Detailed description
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 y/o
- CHF with EF > 35%
- Bilirubinemia, serum transaminase> 2.5 times normal max level
- Creatininemia > 2.5 times max level
- NYHA Class > 3
Key exclusion criteria (4 listed)
- Impossibility to harvest the bone marrow
- Pregnancy or breast-feeding
- History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
- Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.
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 |
|---|---|---|
| intramiocardiac autograft of autologous stem cells | Procedure or surgery | – |
Primary outcome
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
Time frame: 1 YEAR
1 secondary outcome
Secondary target: determine clinical effects of grafted cells on remodeling pathology.
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
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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.
CESARE SCARDULLA, md principal investigator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
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 intramiocardiac autograft of autologous stem cells in people with Congestive Heart Failure, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 1 site in Italy.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Jun 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 Italy. 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?
Contact cesare scardulla, MD (0912192284, cscardulla@ISMETT.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. (time frame: 1 YEAR). 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 Jun 2007.