Status:
UNKNOWN
Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
Red de Terapia Celular
Collaborating Sponsors:
Spanish National Health System
Hospital Universitario Virgen de la Arrixaca
Conditions:
ALS (Amyotrophic Lateral Sclerosis)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective, single-center, rando...
Eligibility Criteria
Inclusion
- Diagnosis of definite or probable ALS according to the criteria established by the World Federation of Neurology
- Patient that provides reasonable assurance of adherence to protocol.
- Neurophysiological data confirming affectation of lower motor neurons in the lumbar region.
- Assessment of motor deficits in dorsiflexion of both feet (4 or 5 points on the MRC scale)
- The patient must fulfill all inclusion criteria.
Exclusion
- Diabetes Mellitus.
- Other diseases that may present with polyneuropathy.
- Previous history of stroke.
- Prior Pathology of the peripheral nervous system affecting one or both lower limbs with or without clinically evident neurological sequelae.
- Pregnant or breastfeeding patients active.
- Patients physiologically capable of becoming pregnant, unless they are using reliable contraception.
- Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
- Positive serology for hepatitis B, hepatitis C or HIV.
- Clinical and anesthesiologic Criteria, contraindicating either sedation or extraction of MO (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture site, etc.)
- Included in other clinical trials in the last 6 months.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02286011
Start Date
November 1 2014
End Date
December 1 2017
Last Update
March 30 2017
Active Locations (1)
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1
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120