New Horizons for the Treatment of Cardiomyopathy in Children

February 15, 2023 updated by: Damascus University

The Effectiveness of Autologous Mono Nuclear Cells in the Treatment of Dilated Cardiomyopathy in Children

Collecting mono nuclear cells from the patient's blood after a course of granulocyte stimulation then injecting them into the weak heart muscle measuring the heart function at the beginning and after 2.4.6 months to assess the improvement due to this procedure, by comparing these patients to patients with the same condition treated the classic way.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dilated cardiomyopathy in children has high morbidity and mortality, current treatment doesn't improve the prognosis and the only cure available is heart transplantation which is limited, has long waiting list (if available), high cost, and has many side effects, leading to the need of novel effective, less costly therapeutic alternatives.

Stem cell therapy has proven to improve the cardiac function, reverse the pathologic histological changes, decrease the morbidity and mortality, offering a possible replacement to heart transplantation, different reports proved the safety and efficacy of this therapy using different types of cells and different routs of application in cardiomyopathy and acute myocardial infarction in children and adults, and in congenital heart disease, but the published cases of this therapy conducted on children with dilated cardiomyopathy are scanty .

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dilated cardiomyopathy diagnosed and treated at least 6 mo. Ago
  • LVEF less than 40%
  • Use of I.V inotropes

Exclusion Criteria:

  • Acute infection
  • Severe organ failure (other than the heart)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells
Biological: mono nuclear cells injection
trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
Active Comparator: control group
children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment
Drug: Digoxin+furosemide+captopril
classical heart failure medical treatment
Other Names:
  • lasix,capoten

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricle ejection fraction (LVEF)
Time Frame: 6 months
measured by echo (mono mode, 3 Dimentional)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Chair: samir srour, prof, membership of the French society of the pediatric cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Cardio-01-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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