Status:
UNKNOWN
Biological Treatment of Amyotrophic Lateral Sclerosis
Lead Sponsor:
Pomeranian Medical University Szczecin
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells infusion in the subjects with diagnosed amyotrophic lateral sclerosis.
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a universally fatal neurodegenerative condition that causes weakness leading to paralysis and death. Life expectancy is less that 5 years. The cause is generally...
Eligibility Criteria
Inclusion
- diagnosis of the ALS disease before the cell transplantation (diagnose established following the El Escorial criteria for definite ALS)
- good understanding of the protocol and willingness to consent
- patient is mentally intact and psychologically stable
- signed informed consent
Exclusion
- Concomitant of other systemic disease or diseases:
- inflammation (high protein or lymphocytosis in the CSF), active infections.
- diabetes,
- cardio-vascular disorders,
- cancer,
- autoimmune diseases
- renal failure,
- impaired hepatic function.
- subject is a respiratory dependent.
- subject unwilling or unable to comply with the requirements of the protocol.
- patient has been treated previously with any cellular therapy.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02193893
Start Date
January 1 2010
End Date
December 1 2017
Last Update
July 18 2014
Active Locations (1)
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1
Department of Neurology of Pomeranian Medical University in Szczecin
Szczecin, Poland, Poland, 71-252