Status:
COMPLETED
Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Instituto de Salud Carlos III
Hospital Universitario Virgen de la Arrixaca
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this clinical trial is to assess the feasibility and the security of the intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Later...
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 18 and less than 70 years old
- Forced Vital Capacity ≥ 50%
- Total time of oxygen saturation \<90% inferior to 5% 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 :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01254539
Start Date
October 1 2010
End Date
November 20 2015
Last Update
March 30 2017
Active Locations (1)
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1
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain