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Trial record 13 of 6528 for:    stem cells

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

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ClinicalTrials.gov Identifier: NCT01933321
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: Intrathecal autologous stem cell Phase 2 Phase 3

Detailed Description:
There is no more extensive information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : September 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2014


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



Primary Outcome Measures :
  1. Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS. [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933321


Locations
Mexico
Servicio Hematología Hospital Universitario
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: David Gomez-Almaguer, MD Hospital Universitario "Dr. José Eleuterio González"
Study Director: Jose C Jaime-Pérez, MD PhD Hospital Universitario "Dr. José Eleuterio González"
Study Chair: Héctor R Martínez-Rodríguez, MD PhD Hospital Universitario "Dr. José Eleuterio González"

Responsible Party: David Gomez Almaguer, Chair of Hematology, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01933321     History of Changes
Other Study ID Numbers: ALS and stem cell therapy
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:
ALS, stem cells

Additional relevant MeSH terms:
Pathologic Processes
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases