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Neurotrophic Bone Marrow Cellular Nests Prevent Spinal Motoneuron Degeneration in Amyotrophic Lateral Sclerosis Patients: A Pilot Safety Study.
MedLine Citation:
PMID:  22415951     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Objective: To assess the safety of intraspinal infusion of autologous bone marrow mononuclear cells (BMNC) and, ultimately, to look for histopathological signs of cellular neurotrophism in amyotrophic lateral sclerosis (ALS) patients. Methods: We conducted an open single arm phase I trial. After six months observation, autologous BMNC were infused into the posterior spinal cord funiculus. Safety was the primary endpoint and was defined as the absence of serious transplant-related adverse events. In addition, forced vital capacity (FVC) and ALS-FRS, MRC and Norris scales were assessed six and three months prior to the transplant and quarterly afterwards for one year. Pathological studies were performed in case of death. Results: Eleven patients were included. We did not observe any severe transplant-related adverse event but there were 43 non-severe events. Twenty-two (51%) resolved in ≤2 weeks and only four were still present at the end of follow-up. All were CTCAE grade ≤2. No acceleration in the rate of decline of FVC, ALS-FRS, Norris or MRC scales was observed. Four patients died on days 359, 378, 808 and 1058 postransplant for reasons unrelated to the procedure. Spinal cord pathological analysis showed a greater number of motoneurons in the treated compared to the untreated segments (4.2+/-0.8 mns/section and 0.9+/-0.3 mns/section, respectively). In the treated segments, motoneurons were surrounded by CD90+ cells and did not show degenerative ubiquitin deposits. Interpretation: This clinical trial confirms not only the safety of intraspinal infusion of autologous BMNC in ALS patients but also provides evidence strongly suggesting their neurotrophic activity.
Authors:
Miguel Blanquer Blanquer; Jose M Moraleda Jiménez; Francisca Iniesta Martínez; Joaquín Gómez Espuch; José Meca Lallana; Ramón Villaverde González; Miguel Ángel Pérez Espejo; Francisco José Ruíz López; José María García Santos; Patricia Bleda Díaz; Virginia Izura Azanza; María Sáez Gallego; Pedro de Mingo Casado; Laura Vivancos Moreau; Rafael Carles Dies; Judith Jiménez Veiga; Joaquín Hernández Palazón; Julia Guardiola Jiménez; Silvia Torres Del Rio; Carmen Antúnez Almagro; Pedro de la Rosa Jiménez; Maria Juliana Majado Martínez; Andrés Sánchez Salinas; Javier López; Juan Francisco Martínez-Lage Sánchez; Salvador Martínez Pérez
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-13
Journal Detail:
Title:  Stem cells (Dayton, Ohio)     Volume:  -     ISSN:  1549-4918     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9304532     Medline TA:  Stem Cells     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 AlphaMed Press.
Affiliation:
Hospital Virgen de la Arrixaca. Universidad de Murcia, Hematopoietic progenitors transplant and cell therapy unit.
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