Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

NCT ID: NCT02492516

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-04-30

Brief Summary

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.

Detailed 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell

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

Group Type: EXPERIMENTAL

mesenchymal stem cells

Intervention Type: BIOLOGICAL

mesenchymal stem cells injection via peripheral vein.

Interventions

mesenchymal stem cells

mesenchymal stem cells injection via peripheral vein.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of department of Regenerative Medicine,Royasn Institute

Masood Nabavi, MD

Role: STUDY_DIRECTOR

Professor associated of neurology, Shahed University

Leila Arab, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine, Royan Institute

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

Related Links

http://royaninstitute.com

Related Info

Other Identifiers

Royan-Nerve-008

Identifier Type: -

Identifier Source: org_study_id