Status:
COMPLETED
Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis pati...
Detailed Description
Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has chan...
Eligibility Criteria
Inclusion
- Diagnose established following the World Federation of Neurology criteria
- More than 6 and less than 36 months of evolution of the disease
- Medullar onset of the disease
- More than 20 and less than 65 years old
- Forced Vital Capacity equal or superior to 50%
- Total time of oxygen saturation \<90% inferior to 2% of the sleeping time
- Signed informed consent
Exclusion
- Neurological or psychiatric concomitant disease
- Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
- Concomitant systemic disease
- Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
- Inclusion in other clinical trials
- Unability to understand the informed consent
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00855400
Start Date
February 1 2007
End Date
February 1 2010
Last Update
December 2 2010
Active Locations (1)
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1
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120