Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
- Estimated Enrollment
- 15
Inclusion Criteria
- Genetic Test confirmation for FSHD
- FSHD phenotype positive
- Age: 18-50
- ...
- Genetic Test confirmation for FSHD
- FSHD phenotype positive
- Age: 18-50
- Both gender
- Weakness of face muscle
Exclusion Criteria
- Not able to sign the consent
- Progressive form of disease
- Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
- Not able to sign the consent
- Progressive form of disease
- Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
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 Criteria
- Genetic Test confirmation for FSHD
- FSHD phenotype positive
- Age: 18-50
- ...
- Genetic Test confirmation for FSHD
- FSHD phenotype positive
- Age: 18-50
- Both gender
- Weakness of face muscle
Exclusion Criteria
- Not able to sign the consent
- Progressive form of disease
- Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
- Not able to sign the consent
- Progressive form of disease
- Co - morbidities: Heart & respiratory diseases,malignancy, rheumatologic disorders
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
Get Well Soon