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

H

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase

Completed
Phase 3
Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Biological: Intrathecal autologous stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT01933321
ALS and stem cell therapy

Details and patient eligibility

About

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

Full description

There is no more extensive information

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Intrathecal autologous stem cells
Experimental group
Description:
Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria.
Treatment:
Biological: Intrathecal autologous stem cell

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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