Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Biological: Intrathecal autologous stem cell

• Registration Number: NCT01933321
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.

Detailed Description

There is no more extensive information

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-02
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years.
• Over 18 years old. Forced vital capacity ≥ 40%.
• One year of evolution.
• Adequate nutritional state

Exclusion Criteria

• Severe bulbar ALS involucre.
• Inadequate nutritional status.
• Spondylotic myelopathy, or abnormalities in imaging study.
• Having concomitant neurological or psychiatric disease.
• Systemic disease with poor-control.
• History of treatment with steroids or immunoglobulins in the last year.
• Participate in the past three months in a Clinical Trial.
• History of malignancy or cancer today.
• Intracranial hypertension.
• Clinical suggestive data of infection in the site of lumbar puncture.
• Tracheostomy.
• Use of mechanical ventilation. Forced vital capacity less than 40%. HIV-seropositive or presence of antibodies against hepatitis B or C in the serological studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrathecal autologous stem cells	Intrathecal autologous stem cell	Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria.

Primary Outcome Measures

Name	Time	Method
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.	up to 12 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS.	During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure

Trial Locations

Locations (1)

Servicio Hematología Hospital Universitario; 🇲🇽 Monterrey, Nuevo León, Mexico