Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral Sclerosis (UwmBmmscALS)
|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.
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|