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Completed

NCT Number: NCT01933321

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Servicio Hematología Hospital Universitario

Monterrey, Nuevo León, 64460, Mexico

About this study

There is no more extensive information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal autologous stem cell

Biological

Mobilization and collection of stem cells for intravenous and intrathecal administration

Primary outcomes

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

    Time frame: up to 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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