Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Forced vital capacity
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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 patients.
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 changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Forced vital capacity
Time Frame: Every 3 months
Secondary Outcomes
- ALS-FRS, MRC and Norris scales(Every 3 months)
- Absence of adverse events(Every week / month depending on the study phase)