NCT01504594

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:

  • 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1.6 years

First QC Date

December 15, 2011

Last Update Submit

August 6, 2013

Conditions

Cardiomyopathy, Dilated

Keywords

Dilated cardiomyopathyIdiopathicBone MarrowStem CellsCD34 +Autologous

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (1)

  • Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.

    6 months

Study Arms (1)

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.

Procedure: Intracoronary autologous stem cell infusion

Interventions

Intracoronary autologous stem cell infusionPROCEDURE

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.

Also known as: Intracoronary CD34+ cell infusion
Patients

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Not signing informed consent
  • Active infection at enrolling time
  • Inadequate G-CSF application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dr. Jose E. Gonzalez

Monterrey, N.l., 64460, Mexico

Location

Related Links

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Consuelo Mancias, Hematologist

    Hematology Service, University Hospital of Monterrey

    STUDY DIRECTOR

  • Gerardo Sanchez, Cardiologist

    Pediatrics Service, University Hospital of Monterrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Hematology Professor

Study Record Dates

First Submitted

December 15, 2011

First Posted

January 5, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

ME(1)