CardiomyopathyNCT04893629
New Horizons for the Treatment of Cardiomyopathy in Children
A study testing mono nuclear cells injection and Digoxin+furosemide+captopril in people with Cardiomyopathy, run by Damascus University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- mono nuclear cells injection and Digoxin+furosemide+captopril
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSyria
- Study dates
- 20 May 2021to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dilated cardiomyopathy diagnosed and treated at least 6 mo. Ago
- LVEF less than 40%
- Use of I.V inotropes
Who cannot join
- Acute infection
- Severe organ failure (other than the heart)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Cardiomyopathy
- Being tested
- mono nuclear cells injection, Digoxin+furosemide+captopril
- Keywords
- Dilated, Cardio-myopathy, pediatric, mono, nuclear, cells
- Medical subject headings
- Cardiomyopathies, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mono nuclear cells injectionBiological
trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
Digoxin+furosemide+captoprilDrug
Also called lasix,capoten
classical heart failure medical treatment
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | children diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells Receives: Biological: mono nuclear cells injection |
| control group | Active comparator | children diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment Receives: Drug: Digoxin+furosemide+captopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricle ejection fraction (LVEF)
measured by echo (mono mode, 3 Dimentional)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start20 May 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: lack of necessary equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- samir srour, prof, Study chair, membership of the French society of the pediatric cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893629
- Sponsor's protocol ID
- UDMS-Cardio-01-2021
- Status last verified
- Feb 2025
- First submitted
- 24 Mar 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23666883Zeinaloo 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.
PubMed 20880092Vrtovec 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.
PubMed 23065358Abdel-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.
PubMed 17533201Mozid 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.
PubMed 21596713
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Autologous Mono Nuclear Cells in the Treatment of Dilated Cardiomyopathy in Children
- ClinicalTrials.gov ID
- NCT04893629
- Acronym / sponsor ID
- UDMS-Cardio-01-2021
- Conditions
- Cardiomyopathy
- Keywords
- Dilated, Cardio-myopathy, pediatric, mono, nuclear, cells
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of necessary equipment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Biological: mono nuclear cells injectionchildren diagnosed with dilated cardiomyopathy , will undergo trans endocardium injection of mono nuclear cells |
| control group | Active comparator | Drug: Digoxin+furosemide+captoprilchildren diagnosed with dilated cardiomyopathy ,will continue the classic medical treatment |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Dilated cardiomyopathy diagnosed and treated at least 6 mo. Ago
- LVEF less than 40%
- Use of I.V inotropes
Key exclusion criteria (2 listed)
- Acute infection
- Severe organ failure (other than the heart)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mono nuclear cells injectiontrans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group | Biological | intervention group |
| Digoxin+furosemide+captoprilAlso: lasix,capotenclassical heart failure medical treatment | Drug | control group |
Primary outcome
Left ventricle ejection fraction (LVEF)
Time frame: 6 months
measured by echo (mono mode, 3 Dimentional)
Results and safety
The study was stopped early (reason given: lack of necessary equipment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 23666883Selem 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.
- Background: PubMed 20880092Zeinaloo 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.
- Background: PubMed 23065358Vrtovec 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.
- Background: PubMed 17533201Abdel-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.
- Background: PubMed 21596713Mozid 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.
- -Wang et al. Stem Cell Research \& Therapy (2019) 10:137Link provided by the sponsor.
- I. M-Behnke et al. Regenerative therapies in young hearts with structural or congenital heart diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samir srour, prof study chair
membership of the French society of the pediatric cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mono nuclear cells injection and Digoxin+furosemide+captopril in people with Cardiomyopathy, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of necessary equipment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricle ejection fraction (LVEF) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893629, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.