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New Horizons for the Treatment of Cardiomyopathy in Children

Primary Purpose

Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
mono nuclear cells injection
Digoxin+furosemide+captopril
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy focused on measuring Dilated, Cardio-myopathy, pediatric, mono, nuclear, cells

Eligibility Criteria

6 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Children'S Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

control group

Arm Description

children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells

children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment

Outcomes

Primary Outcome Measures

Left ventricle ejection fraction (LVEF)
measured by echo (mono mode, 3 Dimentional)

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
February 15, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT04893629
Brief Title
New Horizons for the Treatment of Cardiomyopathy in Children
Official Title
The Effectiveness of Autologous Mono Nuclear Cells in the Treatment of Dilated Cardiomyopathy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy
Keywords
Dilated, Cardio-myopathy, pediatric, mono, nuclear, cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells
Arm Title
control group
Arm Type
Active Comparator
Arm Description
children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment
Intervention Type
Biological
Intervention Name(s)
mono nuclear cells injection
Intervention Description
trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
Intervention Type
Drug
Intervention Name(s)
Digoxin+furosemide+captopril
Other Intervention Name(s)
lasix,capoten
Intervention Description
classical heart failure medical treatment
Primary Outcome Measure Information:
Title
Left ventricle ejection fraction (LVEF)
Description
measured by echo (mono mode, 3 Dimentional)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
samir srour, prof
Organizational Affiliation
membership of the French society of the pediatric cardiology
Official's Role
Study Chair
Facility Information:
Facility Name
Children'S Hospital
City
Damascus
ZIP/Postal Code
011
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23666883
Citation
Selem SM, Kaushal S, Hare JM. Stem cell therapy for pediatric dilated cardiomyopathy. Curr Cardiol Rep. 2013 Jun;15(6):369. doi: 10.1007/s11886-013-0369-z.
Results Reference
background
PubMed Identifier
20880092
Citation
Zeinaloo A, Zanjani KS, Bagheri MM, Mohyeddin-Bonab M, Monajemzadeh M, Arjmandnia MH. Intracoronary administration of autologous mesenchymal stem cells in a critically ill patient with dilated cardiomyopathy. Pediatr Transplant. 2011 Dec;15(8):E183-6. doi: 10.1111/j.1399-3046.2010.01366.x. Epub 2010 Sep 29.
Results Reference
background
PubMed Identifier
23065358
Citation
Vrtovec B, Poglajen G, Lezaic L, Sever M, Domanovic D, Cernelc P, Socan A, Schrepfer S, Torre-Amione G, Haddad F, Wu JC. Effects of intracoronary CD34+ stem cell transplantation in nonischemic dilated cardiomyopathy patients: 5-year follow-up. Circ Res. 2013 Jan 4;112(1):165-73. doi: 10.1161/CIRCRESAHA.112.276519. Epub 2012 Oct 12.
Results Reference
background
PubMed Identifier
17533201
Citation
Abdel-Latif A, Bolli R, Tleyjeh IM, Montori VM, Perin EC, Hornung CA, Zuba-Surma EK, Al-Mallah M, Dawn B. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. doi: 10.1001/archinte.167.10.989.
Results Reference
background
PubMed Identifier
21596713
Citation
Mozid AM, Arnous S, Sammut EC, Mathur A. Stem cell therapy for heart diseases. Br Med Bull. 2011;98:143-59. doi: 10.1093/bmb/ldr014. Epub 2011 May 19.
Results Reference
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Links:
URL
https://doi.org/10.1186/s13287-019-1238-5
Description
-Wang et al. Stem Cell Research & Therapy (2019) 10:137
URL
http://dx.doi.org/10.21037/tp.2019.03.01
Description
I. M-Behnke et al. Regenerative therapies in young hearts with structural or congenital heart disease

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New Horizons for the Treatment of Cardiomyopathy in Children

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