Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

Phase 1

Completed

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

• Registration Number: NCT02492516
• Lead Sponsor: Royan Institute

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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Primary Completion: 2017-03
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell	mesenchymal stem cells	The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.

Primary Outcome Measures

Name	Time	Method
fever	72hours	The increase of body temperature that is defined as fever, within 72 hours after injection.
Unconsciousness	72hours	Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.

Secondary Outcome Measures

Name	Time	Method
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)	2 months	Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
FVC	2 months	Evaluation the improvement of FVC by spirometry, 2 months after cell injection.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of