Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral Sclerosis (UwmBmmscALS)
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|ClinicalTrials.gov Identifier: NCT02881489|
Recruitment Status : Enrolling by invitation
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Other: Biological: Cell-based therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Mesenchymal Stem Cell Culturing Protocols in the Treatment of Amyotrophic Lateral Sclerosis|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Autologous BM-MSCs injection
Intervention: Biological: Cell-based therapy of autologous bone marrow-derived mesenchymal stem cells which are transplanted intrathecally (via a standard lumbar puncture) into the ALS subjects.
Other: Biological: Cell-based therapy
Human autologous bone marrow-derived mesenchymal stem cell transplantation in ALS patients.
- Changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) between patients before and after stem cell transplantation. [ Time Frame: From day of enrolment until the date of first stem cell injection (6 months - first time ALSFRS) + and then every 2 months up to 1,5 year of the trial ]ALSFRS is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. The First time the ALSFRS questionnaire has been dane after enrolment of the patients and then after 6 months of observation and stem cell injections the ALSFRS has been dane every 2 months up to 1,5 year of follow-up period.
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): NCT02881489
|Principal Investigator:||Wojciech Maksymowicz, MD, Prof.||Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland|