Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492516
• Other study ID #: Royan-Nerve-008
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2015
• Last updated: April 26, 2017
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Biological:
• mesenchymal stem cells
mesenchymal stem cells injection via peripheral vein.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fever	The increase of body temperature that is defined as fever, within 72 hours after injection.	72hours
Primary	Unconsciousness	Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.	72hours
Secondary	The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)	Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.	2 months
Secondary	FVC	Evaluation the improvement of FVC by spirometry, 2 months after cell injection.	2 months