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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933321

Enrollment

Registered

2013-09-02

Start date

2012-09-30

Completion date

2014-06-30

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS, stem cells

Brief summary

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

Detailed description

There is no more extensive information

Interventions

BIOLOGICALIntrathecal autologous stem cell

Mobilization and collection of stem cells for intravenous and intrathecal administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.	up to 12 months

Secondary

Measure	Time frame
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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026