Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

NCT02492516 | Completed Phase 1 DMC

• 1 other identifier: Royan-Nerve-008
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

adipose tissue mesenchymal stem cell intravenous injection ALS

Outcome Measures

Primary Outcomes (2)

• fever

  The increase of body temperature that is defined as fever, within 72 hours after injection.

  72hours

• Unconsciousness

  Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.

  72hours

Secondary Outcomes (2)

• The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)

  2 months

• FVC

  2 months

Study Arms (1)

Stem cell

EXPERIMENTAL

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

Biological: mesenchymal stem cells

Interventions

mesenchymal stem cells BIOLOGICAL

mesenchymal stem cells injection via peripheral vein.

Stem cell

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

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

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of department of Regenerative Medicine,Royasn Institute

  STUDY DIRECTOR

• Masood Nabavi, MD

  Professor associated of neurology, Shahed University

  STUDY DIRECTOR

• Leila Arab, MD

  Department of Regenerative Medicine, Royan Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 8, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

IR (1)