Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell–derived exosomes on improvement of lung disease symptoms

Investigating the effectiveness of exosomes derived from placenta mesenchymal stem cells on improving the symptoms of interstitial lung fibrosis in systemic sclerosis patients, a single-arm clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130812014333N224

Enrollment

Registered

2024-08-24

Start date

2024-09-05

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Systemic sclerosis (scleroderma). Systemic sclerosis [scleroderma]

Interventions

The intervention group will receive exosomes derived from stem cells with a dose between 5.2-1011 × 1011 (three sessions intravenously) particles/unit..

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Definitive diagnosis of systemic sclerosis Interstitial lung disease confirmed by chest CT scan and pulmonary function tests Informed consent

Exclusion criteria

Exclusion criteria: Suffering from other autoimmune diseases Uncontrolled high blood pressure Diabetes and other endocrine disorders Cardiovascular failure Chronic kidney failure Liver dysfunction Depression The presence of life-threatening complications including severe hemolysis of platelets below 40,000 Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Lung involvement. Timepoint: The beginning and end of the study (6 months later). Method of measurement: Chest CT scan, pulmonary function tests and spirometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shirin Assar

Kermanshah University of Medical Sciences

sh758us@yahoo.com009883342276301

Outcome results

None listed

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