Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

NCT02116634 | Withdrawn Phase 1 DMC

• 2 other identifiers: rokhsarehstem cell injection in ALS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Whether the mesenchymal injection on ALS patients is effective or not?

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS

  every 6 months up 2 years after transplantation

Secondary Outcomes (2)

• ALS-FRS(functional rating scale) score and EMG scale

  before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation

• FVC (forced vital capacity)and DWSE±QoL score

  before transplantation and every 6 months up 2 years after transplantation

Study Arms (1)

mesenchymal stem cell

EXPERIMENTAL

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Biological: mesenchymal stem cell

Interventions

mesenchymal stem cell BIOLOGICAL

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

mesenchymal stem cell

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sporadic ALS according to escorial criteria
• onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
• mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
• normal polysomnography
• Signed consent form

You may not qualify if:

• pregnancy or lactation,
• vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
• Hospitalization due to serious illness in the last two months
• survival time less than two years
• Hypersensitivity to any component used in the cell culture

Sponsors & Collaborators

• Alzahra Hospital, Iran: lead

Study Sites (1)

Neurosciences Research Center

Isfahan, 0098311, Iran

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• keivan basiri, MD

  Isfahan neurosciences research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: April 17, 2014
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

IR (1)