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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Intrathecal autologous stem cell

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Servicio Hematología Hospital Universitario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrathecal autologous stem cells

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.

Secondary Outcome Measures

To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS.

Full Information

NCT ID

NCT01933321

First Posted

September 28, 2012

Last Updated

April 1, 2015

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

1. Study Identification

Unique Protocol Identification Number

NCT01933321

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

ALS, stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intrathecal autologous stem cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Intrathecal autologous stem cell

Intervention Description

Mobilization and collection of stem cells for intravenous and intrathecal administration

Primary Outcome Measure Information:

Title

Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Gomez-Almaguer, MD

Organizational Affiliation

Hospital Universitario "Dr. José Eleuterio González"

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jose C Jaime-Pérez, MD PhD

Organizational Affiliation

Hospital Universitario "Dr. José Eleuterio González"

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Héctor R Martínez-Rodríguez, MD PhD

Organizational Affiliation

Hospital Universitario "Dr. José Eleuterio González"

Official's Role

Study Chair

Facility Information:

Facility Name

Servicio Hematología Hospital Universitario

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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