Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Alzahra Hospital, Iran

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Biological: mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02116634

rokhsareh

stem cell injection in ALS (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

mesenchymal stem cell

Experimental group

Description:

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

Treatment:

Biological: mesenchymal stem cell