Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Phase 1

Withdrawn

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Biological: mesenchymal stem cell

• Registration Number: NCT02116634
• Lead Sponsor: Alzahra Hospital, Iran

Brief Summary

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

Detailed Description

After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.

Study Timeline

• Study First Submitted: 2014-04-06
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-17
• Study Start: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. sporadic ALS according to escorial criteria
2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
3. 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
4. normal polysomnography
5. Signed consent form

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS	every 6 months up 2 years after transplantation

Secondary Outcome Measures

Name	Time	Method
FVC (forced vital capacity)and DWSE±QoL score	before transplantation and every 6 months up 2 years after transplantation
ALS-FRS(functional rating scale) score and EMG scale	before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation

Trial Locations

Locations (1)

Neurosciences Research Center; 🇮🇷 Isfahan, Iran, Islamic Republic of