Heart FailurePhase 1RCT and SCTNCT00800657
Stem Cells and Resynchronization Cardiac
A Phase 1 study testing Pacing and Stem Cells Implantations. and Pacing and Stem Cells Implantation in people with Heart Failure, run by Instituto de Molestias Cardiovasculares at 1 site in Brazil.
Trial summary
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacing and Stem Cells Implantations. and Pacing and Stem Cells Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Dec 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Dilated Cardiomyopathy
- Heart Failure
- Optimized Therapeutics
- Ventricular Desynchrony
- Functional Class III or IV
- Ejection Fraction(Echo/ Sympson) < 35%
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Imc - Instituto de Moléstias Cardiovasculares
São José do Rio Preto, São Paulo, 15015-210
Oswaldo Tadeu Greco, PhD, 55-17-3203-4000 ext. 4038, oswaldogreco@terra.com.br
Oswaldo Tadeu Greco, PhD
About this study
Official title: Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.
Read the detailed description
About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.
- Conditions
- Heart Failure
- Being tested
- Pacing and Stem Cells Implantations., Pacing and Stem Cells Implantation
- Keywords
- Cardiac Resynchronization, Dilated Cardiomyopathy, Stem Cells Therapy, Heart Failure, Stem Cells/Cardiac Pacing, Artificial
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing and Stem Cells Implantations.Procedure or surgery
Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.
Pacing and Stem Cells ImplantationProcedure or surgery
Pacing and Stem Cells Implantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
Measured: 24 months
Secondary outcomes (1)
Ejection Fraction (Echo/Sympson) and functional class(NYHA).
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Molestias Cardiovasculares
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Oswaldo Tadeu Greco, PhD, Principal investigator, IMC - Institute of Hearth DiseasesOswaldo Tadeu Greco, PhD, Principal investigator, IMC- Institute of Hearth Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800657
- Sponsor's protocol ID
- HFRCTC1
- Other IDs
- HFRCTC1
- Acronym
- RCT and SCT
- Status last verified
- Jun 2011
- First submitted
- 12 Nov 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese.
PubMed 17874006
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
- ClinicalTrials.gov ID
- NCT00800657
- Acronym / sponsor ID
- RCT and SCT / HFRCTC1
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization, Dilated Cardiomyopathy, Stem Cells Therapy, Heart Failure, Stem Cells/Cardiac Pacing, Artificial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto de Molestias CardiovascularesUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Dec 2008 (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.
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.
Detailed description
About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pacing and Stem Cells Implantations.Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics. | Procedure or surgery | – |
| Pacing and Stem Cells ImplantationPacing and Stem Cells Implantation. | Procedure or surgery | – |
Primary outcome
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
Time frame: 24 months
1 secondary outcome
Ejection Fraction (Echo/Sympson) and functional class(NYHA).
Time frame: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Results publication: PubMed 17874006Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese.
- Departamento de Estimulação Cardiaca e Arritmia.Link 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.
Oswaldo Tadeu Greco, PhD principal investigator
IMC - Institute of Hearth Diseases
Oswaldo Tadeu Greco, PhD principal investigator
IMC- Institute of Hearth Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pacing and Stem Cells Implantations. and Pacing and Stem Cells Implantation in people with Heart Failure, run by Instituto de Molestias Cardiovasculares at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Jun 2011. 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 Brazil. 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 Oswaldo Tadeu Greco, PhD (55-17-3203-4000 ext. 4038, oswaldogreco@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative. (time frame: 24 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 NCT00800657, 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 23 Jun 2011.