The survey of efficacy of intracoronary autologous bone marrow-derived mononuclear stem cell injection in treatment of children with dilated cardiomyopathy

The survey of efficacy of intracoronary autologous bone marrow-derived mononuclear stem cell injection in treatment of children with dilated cardiomyopathy (The third phase of clinical trial)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100212003331N2

Enrollment

Registered

2022-01-19

Start date

2022-01-08

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy. Dilated cardiomyopathy

Interventions

Patients choose from all cases of dilated cardiomyopathy without cause or due to myocarditis who have not responded well to the usual routine antifailure treatments and have frequent hospitalizations

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age between 1 to 18 years - Definitive diagnosis of dilated cardiomyopathy without a treatable cause (arrhythmia - ALCAPA - tumors, etc.) Lack of response to maximum oral antifailure treatments and the need for frequent hospitalization or dependence on injectable inotropes4 Lack of response to maximum oral antifailure treatments and the need for frequent hospitalization or dependence on injectable inotropes4- Normal kidney function and no serious functional liver damage (INR> 2 - Alb <3 - AST, ALT more than 3 times of Nl Range). - no hematological disorders No syndromic diseases Accepting the participation form in the study and being aware of the side effects of this treatment - If the initial response is appropriate, increase the EF by 5% in the first injection of the second injection, 3 months after the first injection.

Exclusion criteria

Exclusion criteria: Non-compliance with any of the entry conditions at each stage of the study before stem cell injection Not accepting the informed consent form to participate in the study or performing cardiac angiography. Appropriate response to oral antifailure treatment Active infection Less than 6 months have passed since the diagnosis of dilated cardiomyopathy Existence of refractory arrhythmia due to dilated cardiomyopathy Existence of bleeding and serious coagulation disorder

Design outcomes

Primary

Measure	Time frame
Ejection fraction. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: Echocardiography.;6 Min walk test. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: Test in pediatric cardiology ward.;Speckle echocardiography. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: echocardiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Amoozgar

Shiraz University of Medical Sciences

amozgah@sums.ac.ir+98 71 3647 4298

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026