Biological Treatment of Amyotrophic Lateral Sclerosis (NeuStem-ALS)
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|ClinicalTrials.gov Identifier: NCT02193893|
Recruitment Status : Unknown
Verified July 2014 by Milosz Kawa, Pomeranian Medical University Szczecin.
Recruitment status was: Enrolling by invitation
First Posted : July 18, 2014
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Other: Biological: Cell-based therapeutics Other: Symptomatic treatment of ALS||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety/Efficacy Study for the Biological Treatment of Amyotrophic Lateral Sclerosis With Autologous Stem/Progenitor Cells|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Stem/progenitor cells transplantation.
Intervention: Biological: Cell-based therapeutics Autologous bone marrow-derived stem/progenitor cells will be transplanted intrathecally (via a standard lumbar puncture) into early vs. progressive ALS subjects.
Other: Biological: Cell-based therapeutics
Human autologous bone marrow-derived stem/progenitor cell transplantation in ALS patients.
Sham Comparator: Standard treatment of ALS
Symptomatic treatment of ALS without biologic cell-based treatment
Other: Symptomatic treatment of ALS
Symptomatic neurological treatment of ALS
- Safety of autologous bone marrow stem/progenitor cell infusion in enrolled patients [ Time Frame: 1 year ]Confirm the safety of autologous bone marrow stem/progenitor cell infusion in enrolled patients by repeated follow-up over one year with clinical and laboratory evaluations.
- Efficacy of autologous bone marrow stem/progenitor cell infusion in enrolled patients. [ Time Frame: 1 year ]Confirm the efficacy of autologous bone marrow stem/progenitor cell infusion in enrolled patients by repeated follow-up over one year with clinical and laboratory evaluation tests for neurodegeneration processes analysis and general health outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193893
|Department of Neurology of Pomeranian Medical University in Szczecin|
|Szczecin, Poland, 71-252|
|Study Director:||Boguslaw Machalinski, MD, PhD||Pomeranian Medical University Szczecin|
|Study Chair:||Przemyslaw Nowacki, MD, PhD||Pomeranian Medical University Szczecin|