Cardiomyopathy, DilatedPhase 1NCT01504594
Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
A Phase 1 study testing Intracoronary autologous stem cell infusion in people with Cardiomyopathy, Dilated, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy. Process: 1. Primary Evaluation Clinical History Echocardiogram to evaluate ejection fraction and other parameters 2. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Cardiomyopathy, Dilated
- What is being tested?
- Intracoronary autologous stem cell infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Aug 2013
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ejection fraction less than 35 percent in echocardiogram
- More than 3 months with complete medical treatment without significant improvement
- Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers
Who cannot join
- Not signing informed consent
- Active infection at enrolling time
- Inadequate G-CSF application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.
Process:
Read more
- Primary Evaluation
- Clinical History
- Echocardiogram to evaluate ejection fraction and other parameters
- Signing of Informed Consent and clearing doubts
- Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously
- On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml).
- Recovery room with family members while the cells are being processed in the Hematology Laboratory.
- Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers.
- Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.
- Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.
Read the detailed description
- The Patient will receive standard surgical care, accompanied by a nurse at all times.
- Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).
- Conditions
- Cardiomyopathy, Dilated
- Being tested
- Intracoronary autologous stem cell infusion
- Keywords
- Dilated cardiomyopathy, Idiopathic, Bone Marrow, Stem Cells, CD34 +, Autologous
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary autologous stem cell infusionProcedure or surgery
Also called Intracoronary CD34+ cell infusion
Under sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Children which meet eligibility criteria and after being assessed, are stimulated with G-CSF, undergo bone marrow extraction and then have them applied directly to the coronary arteries through cardiac catheterization. Receives: Procedure: Intracoronary autologous stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
Patient will be assessed to prove that the procedure did not cause any deterioration of his/her health presented at the beginning of the study.
Measured: 6 weeks
Secondary outcomes (1)
Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013 (estimated)
Why it stopped: Suspended because the lack of patients among the time this clinical trial was running.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, DilatedStudies 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Consuelo Mancias, Hematologist, Study director, Hematology Service, University Hospital of MonterreyGerardo Sanchez, Cardiologist, Principal investigator, Pediatrics Service, University Hospital of Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504594
- Sponsor's protocol ID
- HE-2012
- Status last verified
- Aug 2013
- First submitted
- 15 Dec 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01504594
- Acronym / sponsor ID
- HE-2012
- Conditions
- Cardiomyopathy, Dilated
- Keywords
- Dilated cardiomyopathy, Idiopathic, Bone Marrow, Stem Cells, CD34 +, Autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended because the lack of patients among the time this clinical trial was running.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (estimated)
- First posted
- 5 Jan 2012 (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 purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.
Process:
- Primary Evaluation
- Clinical History
- Echocardiogram to evaluate ejection fraction and other parameters
- Signing of Informed Consent and clearing doubts
- Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously
- On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml).
- Recovery room with family members while the cells are being processed in the Hematology Laboratory.
- Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers.
- Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.
- Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.
Detailed description
- The Patient will receive standard surgical care, accompanied by a nurse at all times.
- Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Intracoronary autologous stem cell infusionChildren which meet eligibility criteria and after being assessed, are stimulated with G-CSF, undergo bone marrow extraction and then have them applied directly to the coronary arteries through cardiac catheterization. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ejection fraction less than 35 percent in echocardiogram
- More than 3 months with complete medical treatment without significant improvement
- Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers
Key exclusion criteria (3 listed)
- Not signing informed consent
- Active infection at enrolling time
- Inadequate G-CSF application
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 |
|---|---|---|
| Intracoronary autologous stem cell infusionAlso: Intracoronary CD34+ cell infusionUnder sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries. | Procedure or surgery | Patients |
Primary outcome
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
Time frame: 6 weeks
Patient will be assessed to prove that the procedure did not cause any deterioration of his/her health presented at the beginning of the study.
1 secondary outcome
Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- University Hospital Dr. Jose E. GonzalezLink 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.
Consuelo Mancias, Hematologist study director
Hematology Service, University Hospital of Monterrey
Gerardo Sanchez, Cardiologist principal investigator
Pediatrics Service, University Hospital of Monterrey
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 Intracoronary autologous stem cell infusion in people with Cardiomyopathy, Dilated, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 3 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: paused, as of the sponsor's last update on 9 Aug 2013. 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 Mexico. 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?
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?
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. (time frame: 6 weeks). 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 9 Aug 2013.