New Horizons for the Treatment of Cardiomyopathy in Children

NCT04893629 | Terminated

• 1 other identifier: UDMS-Cardio-01-2021
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy

Keywords

Dilated; Cardio-myopathy; pediatric; mono; nuclear; cells

Outcome Measures

Primary Outcomes (1)

• Left ventricle ejection fraction (LVEF)

  measured by echo (mono mode, 3 Dimentional)

  6 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

Biological: mono nuclear cells injection

control group

ACTIVE COMPARATOR

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

Drug: Digoxin+furosemide+captopril

Interventions

mono nuclear cells injection BIOLOGICAL

trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group

intervention group

Digoxin+furosemide+captopril DRUG

classical heart failure medical treatment

Also known as: lasix,capoten

control group

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Children'S Hospital

Damascus, 011, Syria

Location

Related Publications (5)

• 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.

  PMID: 23666883 BACKGROUND

• 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.

  PMID: 20880092 BACKGROUND

• 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.

  PMID: 23065358 BACKGROUND

• 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.

  PMID: 17533201 BACKGROUND

• 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.

  PMID: 21596713 BACKGROUND

Related Links

• -Wang et al. Stem Cell Research \& Therapy (2019) 10:137
• I. M-Behnke et al. Regenerative therapies in young hearts with structural or congenital heart disease

MeSH Terms

Conditions

Cardiomyopathies; Dilatation, Pathologic

Interventions

Furosemide; Captopril

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• samir srour, prof

  membership of the French society of the pediatric cardiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: May 19, 2021
• Study Start: May 20, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)