??Effect of intrapulmonary injection of stem cells in patients with pulmonary hypertention due to congenital heart defect whose heart disease has been repaired

A Clinical trial to evaluate the effects of intrapulmonary injection of bone marrow derived mononuclear cells along with pulmonary hypertension drugs on pulmonary pressure in patients with Eisenmenger syndrome

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017080435442N1

Enrollment

Registered

2017-10-03

Start date

2017-08-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Eisenmenger's syndrome. other congenital malformation of cardiac septa

Interventions

Bone marrow will be aspirated and cultured. Mononuclear cells will be derived. Cell extraction is based on ficoll based gradient method. The injectable sample is a cell suspension containing at least

Treatment - Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: operated VSD (ventricular septal defect) and pulmonary hypertension (Eisenmenger)? not improved pulmunary HTN 2years after surgery (despite recieving routine medical therapy) Exclusion criteria: absence of consent? finding clot in heart? not tolerating catheterism

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pulmonary artery pressure. Timepoint: before intervention and 1month-3months-6months after procedure. Method of measurement: catheterism and echocardiography.;Pulmonary vascular resistance. Timepoint: before intervention and 1month-3months-6months after procedure. Method of measurement: catheterism and echocardiography.	—

Secondary

Measure	Time frame
Right side cardiac output. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: echocardiography and catheterism.;Patients' functional class. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: echocardigraphy and ECG and 6minutes walking test.;Results of 6 minute walking test. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: 6 minute walking test.	—

Measure

Time frame

Right side cardiac output. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: echocardiography and catheterism.;Patients' functional class. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: echocardigraphy and ECG and 6minutes walking test.;Results of 6 minute walking test. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: 6 minute walking test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Hamid 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