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Exosome-sonotherapy study in dystrophic muscle repair

Investigation of the safety and effectiveness of local administration of exosomes derived from mesenchymal stem cells along with ultrasound radiation in the dystrophic muscle of Duchenne patients: a clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250111064352N1
Enrollment
15
Registered
2025-03-17
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Duchenne patients. Muscular dystrophy

Interventions

Intervention 1: Intervention group 1: the patient group was subjected to selected ultrasound radiation to the internal and external gastrocnemius muscles of the left and right leg and both left and ri

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor
Tarbiat Modares University
Collaborator

Eligibility

Sex/Gender
Male
Age
8 Years to 20 Years

Inclusion criteria

Inclusion criteria: Duchenne patients with a proven in-frame genetic mutation are selected. Movement disorder in lower limbs with age between 8 and 20 years are selected.

Exclusion criteria

Exclusion criteria: Patients with severe movement disorder of the lower limbs and pelvic girdle muscles leading to the inability to walk are not included in the study. People with skin lesions in the areas being treated are excluded. Have no history of allergy to biological products.

Design outcomes

Primary

MeasureTime frame
Muscle thickness. Timepoint: At the beginning of the study (before the start of the intervention), 1 and 3 months after the start of the treatment. Method of measurement: Ultrasound imaging and sequential image processing.;Young modulus. Timepoint: At the beginning of the study (before the start of the intervention), 1 and 3 months after the start of the treatment. Method of measurement: Ultrasound imaging and sequential image processing.;Shear modulus. Timepoint: At the beginning of the study (before the start of the intervention), 1 and 3 months after the start of the treatment. Method of measurement: Ultrasound imaging and sequential image processing.

Secondary

MeasureTime frame
Muscle activity. Timepoint: At the beginning of the study, 1 and 3 months after treatment. Method of measurement: Elastic modulus of muscles.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactManijhe Mokhtari dizaji

Tarbiat Modares university

mokhtarm@modares.ac.ir+98 21 8288 3893

Outcome results

None listed

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