Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02116634
• Other study ID #: rokhsareh
• Secondary ID: stem cell inject
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 6, 2014
• Last updated: January 13, 2016
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: January 2016
• Source: Alzahra Hospital, Iran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Neurosciences Research Center	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Alzahra Hospital, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS		every 6 months up 2 years after transplantation	Yes
Secondary	ALS-FRS(functional rating scale) score and EMG scale		before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation	Yes
Secondary	FVC (forced vital capacity)and DWSE±QoL score		before transplantation and every 6 months up 2 years after transplantation	Yes