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

April 1, 2015 updated by: David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.

Study Overview

Status

Completed

Detailed Description

There is no more extensive information

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Servicio Hematología Hospital Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrathecal autologous stem cells
Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria.
Mobilization and collection of stem cells for intravenous and intrathecal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Gomez-Almaguer, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Study Director: Jose C Jaime-Pérez, MD PhD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Study Chair: Héctor R Martínez-Rodríguez, MD PhD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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