- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933321
Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
April 1, 2015 updated by: David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is no more extensive information
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Servicio Hematología Hospital Universitario
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intrathecal autologous stem cells
Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria.
|
Mobilization and collection of stem cells for intravenous and intrathecal administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
Time Frame: up to 12 months
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Gomez-Almaguer, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Study Director: Jose C Jaime-Pérez, MD PhD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Study Chair: Héctor R Martínez-Rodríguez, MD PhD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 28, 2012
First Submitted That Met QC Criteria
August 30, 2013
First Posted (Estimate)
September 2, 2013
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
April 1, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALS and stem cell therapy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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