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

NCT01933321 | Completed Phase 2

• 1 other identifier: ALS and stem cell therapy
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS, stem cells

Outcome Measures

Primary Outcomes (1)

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

  up to 12 months

Secondary Outcomes (1)

• 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

Study Arms (1)

Intrathecal autologous stem cells

EXPERIMENTAL

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

Biological: Intrathecal autologous stem cell

Interventions

Intrathecal autologous stem cell BIOLOGICAL

Mobilization and collection of stem cells for intravenous and intrathecal administration

Intrathecal autologous stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Servicio Hematología Hospital Universitario

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Gomez-Almaguer, MD

  Hospital Universitario "Dr. José Eleuterio González"

  PRINCIPAL INVESTIGATOR

• Jose C Jaime-Pérez, MD PhD

  Hospital Universitario "Dr. José Eleuterio González"

  STUDY DIRECTOR

• Héctor R Martínez-Rodríguez, MD PhD

  Hospital Universitario "Dr. José Eleuterio González"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Hematology

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: September 2, 2013
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

ME (1)