Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02492516

Enrollment

Registered

2015-07-08

Start date

2014-09-30

Completion date

2017-04-30

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

adipose tissue mesenchymal stem cell intravenous injection ALS

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.

Interventions

BIOLOGICALmesenchymal stem cells

mesenchymal stem cells injection via peripheral vein.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026