Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

Royan Institute

Status and phase: Completed; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02492516

Royan-Nerve-008

Details and patient eligibility

About

Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.

Full description

the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both gender
• Age: 18-55
• Sporadic form of disease
• ALS-FRS> = 24
• FVC >= 40%

Exclusion criteria

• Familial form of ALS
• Malignancy
• Autoimmune disease
• Diagnosis of other motor neuron diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Stem cell

Experimental group

Description:

The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.

Treatment:

Biological: mesenchymal stem cells