Dilated CardiomyopathyPhase 1/2STEMDILCARDNCT00615394
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
A Phase 1/2 study testing intramyocardial bone marrow stem cells implantation in people with Dilated Cardiomyopathy, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- intramyocardial bone marrow stem cells implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2004to Dec 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
- left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
- age below 60 years
- absence of neoplasm
- absence of hematologic disease or systemic disease
- no previous cardiac intervention
Who cannot join
- episodes of tachycardia or ventricular fibrillation
- severe or moderated mitral insufficiency
- any other valvulopathies
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 906200001
About this study
Official title: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- intramyocardial bone marrow stem cells implantation
- Keywords
- cardiomyopathy, stem cell, cardiac failure
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramyocardial bone marrow stem cells implantationProcedure or surgery
Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.
What is being measured
The primary outcome is the main question the study is designed to answer.
safety: morbidity/mortality
Measured: eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionOct 2006
- Study completionDec 2006
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 Dilated CardiomyopathyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615394
- Sponsor's protocol ID
- UP3549/04
- Acronym
- STEMDILCARD
- Status last verified
- Feb 2008
- First submitted
- 1 Feb 2008
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Canedo A, Nardi NB, Sant'Anna JR, Prates PR, Nesralla I. Autologous transplantation of bone marrow mononuclear stem cells by mini-thoracotomy in dilated cardiomyopathy: technique and early results. Sao Paulo Med J. 2008 Mar 6;126(2):75-81. doi: 10.1590/s1516-31802008000200003.
PubMed 18553028
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
- ClinicalTrials.gov ID
- NCT00615394
- Acronym / sponsor ID
- STEMDILCARD / UP3549/04
- Conditions
- Dilated Cardiomyopathy
- Keywords
- cardiomyopathy, stem cell, cardiac failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Feb 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.
Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
- left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
- age below 60 years
- absence of neoplasm
- absence of hematologic disease or systemic disease
Key exclusion criteria (3 listed)
- episodes of tachycardia or ventricular fibrillation
- severe or moderated mitral insufficiency
- any other valvulopathies
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 |
|---|---|---|
| intramyocardial bone marrow stem cells implantationPatients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days. | Procedure or surgery | – |
Primary outcome
safety: morbidity/mortality
Time frame: eighteen 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 14 Feb 2008.
- Derived from this study: PubMed 18553028Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Canedo A, Nardi NB, Sant'Anna JR, Prates PR, Nesralla I. Autologous transplantation of bone marrow mononuclear stem cells by mini-thoracotomy in dilated cardiomyopathy: technique and early results. Sao Paulo Med J. 2008 Mar 6;126(2):75-81. doi: 10.1590/s1516-31802008000200003.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 intramyocardial bone marrow stem cells implantation in people with Dilated Cardiomyopathy, run by Instituto de Cardiologia do Rio Grande do Sul 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?
The sponsor lists 6 inclusion and 3 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 14 Feb 2008. 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 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 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?
safety: morbidity/mortality (time frame: eighteen 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 NCT00615394, 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 14 Feb 2008.