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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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

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Detailed Description

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There is no more extensive information

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intrathecal autologous stem cells

Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria.

Group Type EXPERIMENTAL

Intrathecal autologous stem cell

Intervention Type BIOLOGICAL

Mobilization and collection of stem cells for intravenous and intrathecal administration

Interventions

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Intrathecal autologous stem cell

Mobilization and collection of stem cells for intravenous and intrathecal administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No