Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
15

Inclusion Criterias

Genetic Test confirmation for FSHD
Age: 18-50
Weakness of face muscle
...
Genetic Test confirmation for FSHD
Age: 18-50
Weakness of face muscle
Both gender
FSHD phenotype positive

Exclusion Criterias

Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
Progressive form of disease
Not able to sign the consent
Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
Progressive form of disease
Not able to sign the consent

Summary

Conditions
Dystrophy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Both males and females

Description

In this study, we select 15 patients with FSHD based on eligibility criteria. All the patients underwent physical examination, laboratory evaluations, EMG-NCV, muscle sonography and muscle MRI. Then, a sample of patient's muscle is taken from Biceps Femoralis to isolate and culture of MDSC. The AD-M...

In this study, we select 15 patients with FSHD based on eligibility criteria. All the patients underwent physical examination, laboratory evaluations, EMG-NCV, muscle sonography and muscle MRI. Then, a sample of patient's muscle is taken from Biceps Femoralis to isolate and culture of MDSC. The AD-MSC is prepared from Royan Adipose Tissue Bank. The patient is admitted in general hospital, and the cell suspensions are injected into biceps, triceps and trapezoids muscles by neurologists. After transplantation, the patients will be under observation for 5 hours and will be discharged if no side effect happen. All the patients will be followed at 1,2,4,6 and 12 months after cell injection.

Inclusion Criterias

Genetic Test confirmation for FSHD
Age: 18-50
Weakness of face muscle
...
Genetic Test confirmation for FSHD
Age: 18-50
Weakness of face muscle
Both gender
FSHD phenotype positive

Exclusion Criterias

Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
Progressive form of disease
Not able to sign the consent
Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
Progressive form of disease
Not able to sign the consent

Locations

Tehran
Tehran

Tracking Information

NCT #
NCT02208713
Collaborators
Not Provided
Investigators
  • Study Chair: Hamid Gourabi, PhD Head of Royan Institute Study Director: Nasser Aghdami, MD,PhD Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute Study Director: Mahdi Vahid Dastjerdi, MD Scientific Board of BouAli Hospital, Azad University Principal Investigator: Leila Arab, MD Department of Regenerative Medicine & cell therapy of Royan Institute
  • Study Chair: Hamid Gourabi, PhD Head of Royan Institute Study Director: Nasser Aghdami, MD,PhD Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute Study Director: Mahdi Vahid Dastjerdi, MD Scientific Board of BouAli Hospital, Azad University Leila Arab, MD Department of Regenerative Medicine & cell therapy of Royan Institute