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Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy

NCT01504594 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-08-09

No results posted yet for this study

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.

Conditions

  • Cardiomyopathy, Dilated

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Consuelo Mancias, Hematologist · Hematology Service, University Hospital of Monterrey

  • Gerardo Sanchez, Cardiologist · Pediatrics Service, University Hospital of Monterrey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504594 on ClinicalTrials.gov