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Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504594
Recruitment Status : Suspended (Suspended because the lack of patients among the time this clinical trial was running.)
First Posted : January 5, 2012
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

Tracking Information
First Submitted Date  ICMJE December 15, 2011
First Posted Date  ICMJE January 5, 2012
Last Update Posted Date August 9, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 6 months ]
Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Official Title  ICMJE Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
Brief 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. Signing of Informed Consent and clearing doubts
  3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously
  4. 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).
  5. Recovery room with family members while the cells are being processed in the Hematology Laboratory.
  6. 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.
  7. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.
  8. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiomyopathy, Dilated
Intervention  ICMJE Procedure: Intracoronary autologous stem 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.
Other Name: Intracoronary CD34+ cell infusion
Study Arms  ICMJE Experimental: Patients
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.
Intervention: Procedure: Intracoronary autologous stem cell infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 4, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not signing informed consent
  • Active infection at enrolling time
  • Inadequate G-CSF application
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504594
Other Study ID Numbers  ICMJE HE-2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor  ICMJE Hospital Universitario Dr. Jose E. Gonzalez
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Consuelo Mancias, Hematologist Hematology Service, University Hospital of Monterrey
Principal Investigator: Gerardo Sanchez, Cardiologist Pediatrics Service, University Hospital of Monterrey
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP