Trial record 1 of 97 for:    "DMD-associated dilated cardiomyopathy" OR "Cardiomyopathy, Dilated"
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Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

This study has suspended participant recruitment.
(Suspended because the lack of patients among the time this clinical trial was running.)
Sponsor:
Information provided by (Responsible Party):
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01504594
First received: December 15, 2011
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.

Condition Intervention Phase
Cardiomyopathy, Dilated
Procedure: Intracoronary autologous stem cell infusion
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.


Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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).
  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504594

Locations
Mexico
University Hospital Dr. Jose E. Gonzalez
Monterrey, N.l., Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Study Director: Consuelo Mancias, Hematologist Hematology Service, University Hospital of Monterrey
Principal Investigator: Gerardo Sanchez, Cardiologist Pediatrics Service, University Hospital of Monterrey
  More Information

Additional Information:
No publications provided

Responsible Party: Consuelo Mancias Guerra, Pediatric Hematology Professor, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01504594     History of Changes
Other Study ID Numbers: HE-2012
Study First Received: December 15, 2011
Last Updated: August 6, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Dilated cardiomyopathy
Idiopathic
Bone Marrow
Stem Cells
CD34 +
Autologous

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014