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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933321
• Other study ID #: ALS and stem cell therapy
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 28, 2012
• Last updated: April 1, 2015
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

There is no more extensive information

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Biological:
• Intrathecal autologous stem cell
Mobilization and collection of stem cells for intravenous and intrathecal administration

Locations

Country	Name	City	State
Mexico	Servicio Hematología Hospital Universitario	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.		up to 12 months	Yes
Secondary	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	Yes